Message From the President · species not normally associated with man, in human habitation encroaching upon animal environment. This can be suburban development building into woodland

Inside This Issue:

Book NookPage 3

UCSF AIDS Specimen Bank -30th Anniversary

Page 4

4th ANRRC International MeetingPage 6

OBBR is now BBRB!Page 8

Better Mousetrap: Ambient Storage on Silk: Vaccines and Antibiotics!

Page 8

Komen Tissue Bank Seeking Genetic Clues for Breast Cancer

Page 9

Public Policy Update: New De-identification Guidance

Page 10

Hot TopicsPage 11

5th Annual Beaumont Biobank SymposiumPage 13

Smart MovesPage 14

ISBER Global Expansion FundPage 16

ISBER Members Help Save PreciousSamples at New York Biorepositories

Page 17

Better Mousetrap: Calculating SampleVolume Using Weight

Page 21

ESBB Biobanking ConferencePage 23

Better Mousetrap: Trinean’sDropSense96/cDrop Platform for

Sample Prep QCPage 25

Message From the PresidentI hope everyone had a wonderful holiday season and is enjoying a happy newyear! 2012 was a very productive year for our Society and we have many excitingthings to look forward to in 2013, not least of which will be our next annual meeting& exhibits in Sydney, Australia. We have another record breaking year for abstractsubmission, with 172 abstracts submitted and accepted from countries across theglobe. The submissions are excellent, covering many new topics and providingmore evidence-based data than ever before. It is clear that Turning the WorldUpside Down: Emerging Perspectives on Biorepositories is an appropriate themefor our 2013 meeting.

The ISBER Council, Chapter, Working Groups and Committees all have had a very productive endof the year. The second annual ESBB meeting took place in Granada, Spain between the 9th and11th of November with the theme Biobanks—Advancing Science and Serving Society in the 21stCentury. The meeting was a huge success with 523 participants joining this regional meeting!

Our Proficiency Testing (PT) program launched additional schemes for cell viability, tissue histologyand tissue antigenicity. In December, we conducted surveys for these new schemes and for theexisting DNA quantification and purity and RNA integrity schemes. We had 97 registrations for 118methods this year, which is almost twice the level of participation we had in 2011.

As I mentioned in my August message, a major focus of the 2012-2013 ISBER Council has been tore-evaluate our support structures to ensure we are properly positioned for continued global growth.As part of this process, the Strategic Planning Committee evaluated our strategic plan foreffectiveness and re-assessed the goals for our Society. The strategic plan was revised as a result

Editor’s CornerBIG BREAKING NEWS FOR 2013: Long-time ISBER member Rick Michels ofDataworks Development, Inc., has graciously agreed to serve as the next ISBERNewsletter Editor. Prior to Rick and his wife Cheryl (our esteemed ISBERSecretary-Treasurer) forming their software company in the 1980s, Rick was awriter for several publications. (That already gives him way more capability thanthe current ISBER Editor, whose writing style was forever ruined after a careerspent writing government-speak…) In a feature article on their company’s historythat Rick wrote for our October 2012 issue, he described his role as “thecompany’s ‘utility infielder’ who handles Marketing and Customer Relations, and

also serves as the company ‘visionary’.” He also possesses two of the attributes most needed inthis job: people skills and a strong sense of humor. We will work together for this issue and the next,to provide a smooth transition.

Whenever I do the quarterly trolling exercise for contributions for the newsletter,it’s always with fingers crossed that I’ll be able to get enough articles topull the issue together. The response this time has really exceeded

www.isber.orgVol. 13, No. 1, January 2013

Promoting consistent, high quality standards, ethical principles and innovation in biospecimen banking throughout the global biobanking community.

(Continued on page 2)Message From the President

(Continued on page 3)Editor’s Corner

Council

Katheryn E. Shea, BS President

Marianne K. Henderson, MS Past President

Fay Betsou, DrSc HDR President-Elect

Cheryl Michels Secretary-Treasurer

Heather Siefers, MS Secretary-Treasurer-Elect

Paul Bartels, PhD, BVSc Councilor

Lori D. Campbell, PhD Councilor

Jane Carpenter, MAppSci, FIBMS Councilor, Program

Committee Co-Chair

Rebecca Pugh, MS Councilor

Andy Zaayenga Councilor

Ex-Officio Members

Roger L. Aamodt, PhD Strategic Planning

Committee Chair

Robert Hewitt, MBBS, PhD Publications Committee Chair

David Lewandowski Marketing Committee Chair

Peter Riegman, PhD Chapter Liaison - ESBB

Brent Schacter, MD FRCPC Program Committee Co-Chair

Katherine C. Sexton, MBA Education and Training

Committee Chair

Nicole Sieffert, CCRC Science Policy Committee

Administrative Chair

Mark E. Sobel, MD, PhD Executive Officer

Society Office Staff

Ann Marie Bocus Membership Manager

James Douglas, CPA Chief Operating Officer

Sara Hamilton Meetings Manager

Laurie Menser Director of Marketing and

Development

Chris Wallington Web Developer

Michele Zink Project Manager

ISBER News Editor

Elaine W. Gunter, MT (ASCP)

ISBER News is published 4 times per year. Copyright by theInternational Society for Biological and EnvironmentalRepositories. Newsletters are posted in PDF format on theISBER website at www.isber.org/newsletters/.

Advertising rates are posted on the ISBER website atwww.isber.org/advertising/, or direct inquiries to Laurie Menser,Director of Marketing and Development at [email protected],Tel: 301-634-7908.

International Society for Biological and

Environmental Repositories (ISBER)

9650 Rockville Pike, Suite E133Bethesda, MD 20814-3993 (USA)

Tel: 301-634-7949, Fax: 301-634-7990Email: [email protected], Web: www.isber.org

ISBER is a division of the

American Society for Investigative Pathology (ASIP)

www.asip.org

International Society for Biological and Environmental RepositoriesISBER News, Vol 13, No. 1, January 2013 Page 2


Message From the President(Continued from page 1)

of these evaluations and the updated plan was approved by theISBER Council at our November meeting. We will focus on nine goalsover the next five years and have identified sub-goals and tasks foreach of the major goals. Our standing committees and workinggroups are evaluating how they will accomplish the goals and whatmetrics we will use to track progress. The major goals are:

Goal 1: Improve ISBER’s Financial StatusGoal 2: Increase ISBER’s Organizational EffectivenessGoal 3: Encourage International ParticipationGoal 4: Encourage Participation from a Wide Range of

RepositoriesGoal 5: Advance the Field of BiobankingGoal 6: Improve Membership ServicesGoal 7: Partner with Other Organizations and CommunitiesGoal 8: Influence, Educate and Inform the Broader

Community about Emerging Ethical, Legal and Social Issues Associated with Biorepositories

Goal 9: Increase Society Membership

In order to ensure we have the proper infrastructure to accomplishthese goals, the Council formed a task force at the beginning of myterm to evaluate the management support structure in place and tolay out the requirements for the support that will be needed in thefuture. I appreciate all of the effort that the task force has dedicatedto ensuring the future success of ISBER. Major emphasis is beingplaced on ensuring that we are positioned for global growth withbroad representation from the biorepository community. Additionalinformation about the findings of the task force and therecommendations of the Council will be disseminated to themembership in the near future.

Please remember that in order for our Society to be successful weneed your help! If you are interested in volunteering, please visit ourwebsite (www.isber.org/GetInvolved) to learn more about ourcommittees and working groups. In 2013, we will be introducingSpecial Interest Groups (SIGs) to allow our members to focus onparticular topics of interest. SIGs differ from working groups in thatthey are not expected to develop work products such as publications.Rebecca Pugh, the Chair of our Working Group Chairs Committee,will be providing additional information about SIGs and how you canstart one for your special interest.

Kathi SheaVice President, Bioservices OperationsPrecision Bioservices, Inc

Book NookBy Andy Zaayenga

The Book Nook is a column for ISBER members to talk about bookswe’ve read that we feel could be interesting for our colleagues. Areyou reading a book (scientific or not) you’d like to share with theISBER community? It doesn’t have to be science related. Share itwith us! Email your suggestions to: [email protected].

Title: Spillover: Animal Infections and

the Next Human Pandemic

Authur: David Quammen

Description from Amazon.com(http://www.amazon.com/Spillover-Animal-Infections-Human-Pandemic/dp/0393066800/)

Amazon’s rating: 4.7 out of 5 starsAmazon’s synopsis: The emergence of

strange new diseases is a frightening problem that seems to begetting worse. In this age of speedy travel, it threatens a worldwidepandemic. We hear news reports of Ebola, SARS, AIDS, andsomething called Hendra killing horses and people in Australia—but those reports miss the big truth that such phenomena are partof a single pattern. The bugs that transmit these diseases share onething: they originate in wild animals and pass to humans by aprocess called spillover. David Quammen tracks this subject aroundthe world. He recounts adventures in the field—netting bats inChina, trapping monkeys in Bangladesh, stalking gorillas in theCongo—with the world’s leading disease scientists. In SpilloverQuammen takes the reader along on this astonishing quest to learnhow, where from, and why these diseases emerge, and he asks theterrifying question: What might the next big one be?

ISBER reviewer Andy Zaayenga rates this book: êêêêê

“Zoonoses - pathogens such as a virus, bacterium, prion, or fungusthat are transmitted from animals to human, are the focus of thisexcellent book. Quammen writes in a manner that is very accessibleto a non-scientist, and the presentation is compelling. Although Iread quite a bit about pathogens this book really captivated me. Ilearned a lot about amplifier species (an animal that accelerates avirus' lethality between the reservoir species and humans), why batsare such a common pathogen reservoir, Lyme disease, caterpillarpopulation cycles, avian influenza, the long genesis of AIDS andmore. I was fascinated by his description of how a virus essentiallyliquefies a caterpillar. At the same time he debunks the descriptionof how Ebola melts away a person's organs and sends gushers ofblood from every orifice, so terrifyingly depicted in The Hot Zone.

Quammen relates that the common scenario for emergence of azoonotic pathogen is the forced intersection of humans and animalspecies not normally associated with man, in human habitationencroaching upon animal environment. This can be suburbandevelopment building into woodland as in Lyme disease orbushmeat consumption while timber is felled in the rain forests asin HIV. He leaves little doubt that "the next big one" will be azoonotic disease generated by just such a situation.”

- Andy’s review on Goodreads(http://www.goodreads.com/review/show/450208291)



Editor’s Corner(Continued from page 1)

my expectations. We always strive fora good balance representing the widevariety of ISBER members, and thisissue really reflects that varietyperfectly. After you’ve read this issue,you may be thinking, “Hmm, ourbiorepository/collection/business/grouphas a great story to tell, too.” Act on it,send us a note ASAP! Remember, ourmotto is “It’s all about telling us yourstory.” The blessing of an electronicnewsletter is fewer size lengthlimitations!

This month, the LISTSERV was reallybusy with discussions (one of the great

advantages of ISBER membership, to get lots of good adviceanswers right away when you have a burning question), so we havea lengthy HOT TOPICS section in this issue. Of great interest wasthe timely discussion on long-term storage of specimens at -80°Cvs VP-LN2 or LN, and in hot discussion thereafter, more than 20members posted notes about problems with the compressors ofone particular type of mechanical freezer.

A terrific new feature that we are inaugurating this month is Andy

Zaayenga’s “Book Nook” contribution. Andy will review a new bookeach issue from his lengthy GoodReads personal list (suggestedcontributions from our readers are also welcome). He promises tochallenge our minds and this issue’s selection is a perfect example.Plans are well underway for our 2013 ISBER meeting in Sydney,so I hope everyone is looking forward to the excitement of this greatexperience. I know that both the Program and MarketingCommittees have been working hard. Those of you whoparticipated in the 2012 5K Race, be sure and sign up early; the 2013 t-shirt is going to be a great collectible!

Keep those cards, letters, dark chocolate, and newslettercontributions coming!

Elaine GunterISBER Newsletter Editor

Rick Michels

ISBER 2013 Annual Meeting

& ExhibitsMay 5-9, 2013, Sydney, Australia

www.isber.org/2013



UCSF AIDS Specimen Bank – 30th

Anniversary

In the summer of 1981, the Center for Disease Control (CDC)reported five cases of Pneumocystis carnii pneumonia among fiveyoung homosexual men. A month later 26 cases of Kaposi’ssarcoma were reported in New York and San Francisco.

The University of California San Francisco (UCSF) AIDS SpecimenBank (ASB) was founded on December 2, 1982 in response to thegrowing epidemic of AIDS. The causative agent was unknown andDr. John Greenspan along with investigators from pathology,infectious diseases, dentistry, oncology, epidemiology, andpediatrics developed a small biobank for the processing, storage,and dissemination of specimens.

ASB has evolved from a single staff member and one freezerbiobank to a mid-size biobank that has 25 ultra-low and 15 liquidnitrogen freezers, 6 full-time staff, a director and co-director. As acampus resource, ASB provides its repository services toinvestigators involved in HIV and non-HIV studies at UCSF. During2012, ASB received and processed over 30,000 sets of studyparticipant samples and sent out 40,000 vials. (see graph below)

Evolution of ASB

In the early days of ASB, specimen tracking was done on a wordprocessor and a lab notebook. Today ASB’s database tracks theexact location of each cryovial within a freezer, which allows foraccurate retrieval of specimens to be shipped for analysis. ASB’sfirst alarm system was a monitoring system that was hard-wired intothe telephone system. This system would monitor ultra-low freezers

only. Whenever there was a power outage or freezer failure, ASBstaff would be contacted by telephone. ASB’s current alarm systemis a web-enabled, wireless system that monitors ultra-low and liquidnitrogen freezers. The alarm system sends email and textmessages when there is a freezer failure or power outage.

ASB laboratory has been designed to have areas designated forspecific biobanking tasks. ASB occupies a biosafety Level 2laboratory and there are individual rooms for specimen processing.Other areas of the bank are designated for specimens receipt,specimen shipment, data entry, specimen inventory, and freezerspace. Due to space limitations the majority of ASB freezers arelocated off the main campus, about 30 minutes away by car. Thatoff-site facility has emergency backup power and support staff thatmonitor the freezers.

Nature and Human Made Incidents

The director and co-director of ASB plan for growth, review changesin technology, and emergencies. Over the past 30 years, ASB hasexperienced events due to natural and human made incidents.

Examples of human-made incidents are power-outages due toremodeling of laboratories on campus or utility firms repairing anunderground power line. A group of laboratory/repository managersmet with campus facility executives to explain that communicationmemos must be sent out electronically to alert laboratories thatpower will be shut down in certain areas of a building. Thelaboratory/repository managers emphasized that shutting off powerfor more than 4-6 hours was detrimental to the freezers and theircontents. This meeting led to improved communications betweenthe biobanks, laboratories and facility personnel. Today, emails aresent out two weeks in advance of power outages and they arelimited to one or two hours.

(Continued on page 5)UCSF AIDS Specimen Bank

UCSF AIDS Specimen Bank(Continued from Page 4)

The Loma Prieta 1989 earthquake was a major event. Once theearthquake hit, all power was lost on the campus for several hours.Emergency power was available for the hospital only. ASB staffmembers evacuated the building and returned as soon as they wereinformed the building was safe. The freezers held temperatureduring the power outage. Emergency supplies of dry ice were madeavailable for labs with freezers. Today, UCSF has emergency powerfor laboratories, but in a limited capacity. ASB director and co-director decided that it would be advisable to move the majority oftheir freezers off-campus to a location that provided emergencyback-up power. Our first rental space was located in the basementof Irwin Memorial Blood Bank. Eventually we had to move due toincreasing research demand at the blood bank.

ASB’s freezers are now located at the UCSF Freezer Farm nearSan Francisco International Airport. The facility has emergencybackup power, empty back-up freezers and support staff that

monitor the freezers for temperature fluctuations. ASB installed awireless alarm system at the Freezer Farm and at their processinglabs located on the main campus. This allows ASB staff to view thestatus of freezers anytime.

Recently, we had a heavy storm that affected the T-line connectionto the internet at the Freezer Farm. We were unable to monitor ourfreezers but one of the staff members at the Freezer Farmvolunteered to go to the warehouse and monitor the freezers. Healso contacted AT&T and informed them of the problem. The co-director and the freezer farm staff member were in constant contactover the weekend of the storm. Internet connection was sporadicduring the stormy weekend thus we were able to receive intermittenttemperature readings.

ASB has been providing its biobanking services to the researchcommunity at UCSF for thirty years. We will continue to providequality specimen management to our customers, provide well-characterized specimens to support UCSF investigators basic andtranslational research objectives, and provide consultation toinvestigators seeking information on optimal specimen collection,processing, storage, and shipment. As technology changes, ASBwill continue to seek new methods in the improvement and qualityof specimen processing and storage.



ASB freezers stored at UCSF Freezer Farm.

ASB staff checking in specimens.

Joy Dionisio pulling an order for plasmaand serum.

LN2 freezers at processing lab.

Director, Dr. John Greenspan (L) and Co-Director, Yvonne De Souza


International Society for Biological and Environmental RepositoriesISBER News, Vol. 13, No. 1, January 2013 Page 6

The 4th ANRRC International Meeting

in Korea By Kyungsook Ahn, PhDManager of Department of Education & Research, KNRRC

The Korea National Research Resource Center (KNRRC) hostedthe 4th Asian Network of Research Resource Centers (ANRRC)International Meeting Oct. 17-19, 2012 at the ShineVille Resort onJeju Island, Korea. More than 200 attendees from 18 countries werepresent to hear the latest developments related to biologicalresearch resources. The meeting included an opening ceremonyand plenary lectures, 8 parallel sessions, an ISBER workshop, ageneral assembly and closing ceremony.

One of the highlights of the meeting was signing a Memorandumof Understanding between the European, Middle Eastern & AfricanSociety for Biopreservation & Biobanking (ESBB) and the ANRRC.With the goal of maintaining maximum cooperation, the presidentsof the two societies (Dr. Peter Riegman and Dr. Yeonhee Lee)signed the memorandum at the general assembly. The cooperationwill facilitate access to information, promote joint research and invitespeakers to annual meetings.

In the plenary session, Dr. Yuichi Obata, Director of the RIKENBioResource Center (BRC) and incoming President of ANRRC,emphasized the importance of staff training and of securing long-term funding. He presented Japan’s National Bioresource Project(NBRP) supporting 29 core facilities and how they try to meet theneed of scientific researchers. One example is that all human iPS(induced Pluripotent Stem) cells and mouse strains generated byKyoto University’s Nobel Prize laureate Dr. Shinya Yamanaka’sresearch on regenerative medicine have been deposited in the BRCand are being distributed for research. The second lecture wasgiven by Dr. Xiuzhu Dong (Institute of Microbiology, ChineseAcademy of Sciences, IMCAS) on Metagenome-based generesources. Dr. Lee then discussed the foundation of ANRRC andits future directions. Former ISBER and ESBB President Dr.Riegman then presented how the ESBB was organized as aregional chapter of ISBER. Lastly, Dr. Shyamkumar Sharma

(India) lectured on Bioresource regulatory mechanism inaccordance with the Convention of Biological Diversity (CBD) andAccess to genetic resources and Benefit Sharing (ABS).

Animal and microbial resources were covered in the New Methodsand Application session and plant resources in the Regulation andUtilization of Biological Resources session. A Data Managementsession was organized by Dr. Juncai Ma (IMCAS) who introducedthe global catalogue of microorganisms. The fourth joint seminarwas held as a full-day session and the main topics wereenvironmental application of microalgae and zebrafish as aresearch model. The Korea Biobank Network (KBN) and NationalCulture Collection for Pathogens (NCCP) were introduced in theNational/Regional Network of Research Resource Centers session.Diverse resources in Asian countries were also presented, includinganimal resources of Malaysia, a biobank in Yanbian, China, plantresources in India, and microbial resources in Vietnam.

Because of Dr. Tan Soo Yong’s (Singhealth Tissue Repository)efforts organizing the biobanking sessions, the 4th ANRRC meetinghad more lectures on the subject of human-derived specimens thanprevious meetings. Two biobanking sessions consisted of 12 oralpresentations by prominent speakers from 9 countries. Dr. Yukio

Nakamura gave a talk about the collection of human cell lines atRIKEN BRC and the latest national biobank project “Tohoku Medical

Megabank Organization” for revival of the areas devastated by thedisaster that occurred on March 11, 2011. Jane Carpenter

(Australian Breast Cancer Tissue Bank) introduced biobanking inAustralia and its support for basic and translational research. Dr.

Robert Hewitt outlined how to secure long-term funding forhospital-integrated biobanks in the Biobanking of Human-derivedSpecimens session. Dr. Tan introduced Singapore’s unique‘donation’ system of tissues samples by patients and discussedethical and legal issues. Dr. Chon Boon Eng (Tissue Repository,National University Health System, Singapore) introduced theISBER Best Practices and Self-Assessment Tool (SAT) andbiorepository accreditation. The current status of biobanking inAsian countries was presented by Dr. Endang SR Hardjolukito

(Indonesia), Dr. Menghong Sun (Shanghai Cancer Center, China)and Dr. Quehn Park (Human Serum Bank of Korea). Dr. El-Nasir

Lalani (Aga Khan University, Pakistan) gave a clear comparison ofbiobanking and tissue banks of United Kingdom and Pakistan. Dr.

Anwar Ali Siddiqui, also from Pakistan, discussed the difficultiesin setting up a tissue bank in developing countries.

Dr. William Grizzle and Katherine Sexton held a highly interactiveISBER workshop on “How to Start a Biobank: Designing andMaintaining a Tissue Repository.” They also gave permission totranslate the workshop handout into Korean so the workshopmaterial will be more accessible to Korean researchers. As arepresentative of ISBER, Jane Carpenter attended the ANRRCExecutive Board meeting, at which 12 board members, 2 observersand secretariats were present. The board members agreed to inviteAustralia and New Zealand as ANRRC member countries.

At the closing ceremony Dr. Lee handed the ANRRC gravel to Dr.Obata and ended her 2-year term as the first president of ANRRC.Under Dr. Obata’s leadership, ANRRC hopes to expand itsmembership and strengthen the network among Asian biologicalresource centers. The presentation files are posted on the ANRRCmeeting homepage (http://anrrc2012.knrrc.or.kr). After the meeting,participants took an optional tour of the Citrus Research Station and the Oedolgae seashore trail.

The next meeting will be hosted by RIKEN BRC, Japan. Weanticipate meeting new members from Australia and New Zealand,and colleagues from Europe and America are always welcome.

Presidents of ANRRC (from left to right – Yeonhee Lee, founding president, YuichiObata, the 2nd president, Xiuzhu Dong, vice president and president-elect)

(Continued on page 7)4th ANRRC International Meeting



4th ANRRC International Meeting - Group Photo

Katherine Sexton and William GrizzleSigning the Memorandum of Understanding between ANRRC and ESBB, YeonheeLee and Peter Riegman.

4th ANRRC International Meeting(Continued from Page 6)



OBBR is now BBRB!

The United States National Cancer Institute(NCI) Office of Biorepositories andBiospecimen Research (OBBR) hasundergone an organizational transition withinthe NCI and is now known as theBiorepositories and Biospecimen ResearchBranch (BBRB).

The BBRB will continue its mission to raise thequality of biospecimens for research andmolecular medicine. Many of the staff in thenew branch transitioned from the OBBR,including Jim Vaught (Branch Chief), Helen

Moore, and Chana Rabiner, and contractors Latarsha Carithers,

Phil Branton, and Ben Fombonne. New faces include Lokesh

Agrawal and Ping Guan.

The activities of BBRB include the following:

n BIOSPECIMEN STANDARDS: Creating and Facilitating Biospecimen Standards Development and Adoption.

n BIOSPECIMEN RESEARCH: Developing scientific evidence to drive harmonization of biospecimen practices across different NCI and NIH-funded research programs.

n TOOLS AND PUBLIC PRODUCTS: Public resources for the research community.

n TECHNICAL ASSISTANCE: Provision of expert assistance to NCI, NIH, and the research community atlarge.

Specific continued activities include the NCI Best Practices forBiospecimen Resources, the Biospecimen Research Network(BRN), the Biospecimen Research Database, and biospecimenacquisition for the NIH GTEx program. Some new activitiesinclude the expansion of the NCI Best Practices project to includeEvidence-Based Biospecimen Best Practices as well as new workin biorepository economics research and tool development.

BBRB’s new parent organization is the NCI Cancer DiagnosisProgram, led by Associate Director Barbara Conley. The CancerDiagnosis Program (CDP) strives to improve the diagnosis andassessment of cancer by effectively moving new scientificknowledge into clinical practice. This national program stimulates,co-ordinates and funds resources and research on diagnosticsand improved technologies to better characterize cancers toguide the choice of treatment as well as to evaluate the responseto treatment. BBRB contributes to the goals of CDP byimplementing programs that will promote the collection of highquality specimens that can be used for assay development,biomarker discovery, and broad future research.

Better Mousetrap: Ambient Storage on

Silk: Vaccines & Antibiotics!!!

ISBER member and passionate technophile Jim Robb broughtthis one to our attention.

It is very expensive, difficult, and often ineffective to store and shipvaccines and antibiotics around the globe because of the need tooften refrigerate and/or freeze (freeze drying is also a bit expensive)the substance. The Science Translational Medicine and Economistarticles mentioned below describe an inexpensive way to store andship vaccines and antibiotics (and many other biomolecules) atAMBIENT temperature using silk.

Abstract: Sensitive biological compounds, such as vaccines andantibiotics, traditionally require a time-dependent "cold chain" tomaximize therapeutic activity. This flawed process results in billionsof dollars worth of viable drug loss during shipping and storage, andseverely limits distribution to developing nations with limitedinfrastructure. To address these major limitations, we demonstrateself-standing silk protein biomaterial matrices capable of stabilizinglabile vaccines and antibiotics, even at temperatures up to 60°Cover more than 6 months. Initial insight into the mechanistic basisfor these findings is provided. Importantly, these findings suggest atransformative approach to the cold chain to revolutionize the waymany labile therapeutic drugs are stored and utilized throughoutthe world. Proc Nat Acad Sci 2012;109:11981-6.

Although not overly exponential, this novel idea is a significant stepin providing people in the world's less accessible regions thevaccines and/or antibiotics they need. Check this link at theEconomist Online for a picture of the silk pouches (about the sizeof a cotton balls): http://www.economist.com/blogs/babbage/2012/07/vaccine-technology/print.

Jim Vaught Branch Chief

Read the 3rd Edition of theISBER Best Practices (BP) forRepositories: Collection,Storage, Retrieval andDistribution of BiologicalMaterials for Research,published in the April 2012issue of Biopreservation andBiobanking (BIO).

ISBER Members:

Access BIO online atwww.isber.org/members

ISBER Best Practices

for Repositories



Seeking Genetic Clues for Breast

Cancer: Komen Tissue Bank to Collect

Samples in Kenya

The Susan G. Komen for the Cure® Tissue Bank at the IU SimonCancer Center, also known as the Komen Tissue Bank (KTB),collects healthy breast tissue for breast cancer research. Locatedin Indianapolis, Indiana, in the Midwest region of the United States,it is the only known biobank of its kind in the world. Since 2006, theKTB has been collecting and storing breast tissue, whole blood,serum, and plasma, and making the samples available to scientistsaround the world to use in research which seeks a cause and a curefor breast cancer.

To date, the Komen Tissue Bank has collected tissue samples frommore than 3,000 donors, mainly from women in the MidwesternUnited States. Over the years, it has become increasingly evidentthat special steps would need to be taken to ensure that these tissuesamples would be collected from a diverse population of women.Breast cancer affects people of different races and ethnicities indifferent ways, and the KTB has made it a priority to collectethnically and regionally diverse samples so that studies can bemade which take these differences into account. As an example,even though Caucasian women have the highest incidence ofcontracting breast cancer, women of African descent are more likelyto get a more aggressive form of the disease called Triple Negative.This type of cancer is more likely to be resistant to treatment, andwomen who contract it have a significantly higher likelihood of dyingfrom their breast cancer. The Komen Tissue Bank believes that itis very important to examine why.

In January 2012, Indy’s Super Cure, a partnership between the KTBand the Indianapolis Super Bowl Host Committee, was successfulin raising both awareness and funding for the tissue bank. Becauseof the fundraising, the KTB will be able to travel to Kenya to collectscientifically valuable samples from Kenyan tissue donors.

The KTB plans to travel to Eldoret, Kenya in January 2013 to meetwith doctors and administrators of Moi University School of Medicineand the Moi Teaching and Referral Hospital, as well as to interactwith city and community residents. The emphasis for the Januaryvisit will be to acquire and exchange information necessary to planan actual tissue collection in July 2013.

Why do we need to collect healthy breast cancer tissue?

Cancer can be described as a “control signal” problem: the wrongpopulation of cells experience uncontrolled growth. In breast cancerit seems to make sense that if it were known what the signals looklike in normal settings, we would have clues as to what is goingwrong when cancer develops.

What is the importance of collecting the tissue of women in

Africa?

It is becoming increasingly clear that breast cancer is a differentdisease in women of African descent. It is very important that thisgenetic link be identified. As an example, the incidence of breastcancer for women in Japan is significantly lower than for Caucasianwomen in America. When Japanese women come to live in theUnited States, however, after three generations, the Japanese havethe same risk for developing breast cancer as American women, aswell as contracting the same types of cancer as Caucasian women.

Is this because of the diet and environment in America? If so, it hasnot happened in the African American community, which continuesto have much higher rates of risk and incidence. Clearly there is agenetic effect. We know that African American women have a widediversity of backgrounds. We need to understand why Africanwomen, and those of African descent, develop different breastcancer. If the breast cancer is different, then is the breast different?

There would be many ways to measure the success of doingresearch with samples acquired by the KTB. Perhaps there couldbe an outcome similar to the sickle cell story. Sickle cell anemia isvery common in Africa. The question could be raised: if sickle cell isbad, why has it not genetically cycled out? As it turns out, sickle cellwas determined to be protective against malaria. Could there be agenetic reason why Triple-Negative breast cancer is so prevalent inAfrica and in those of African descent? This is just an example ofsome theories which may be followed by researchers seeking to doprojects using the tissue samples taken from African women.

Why Kenya in particular?

In 1989, Indiana University and Moi University partnered to establishAMPATH, which focused on treating those infected with HIV/AIDS.Today, AMPATH has grown to encompass knowledge and treatmentof other health concerns, including oncology. Because of thispartnership and growth, a sound infrastructure is already in placein Kenya. The existing facilities in Eldoret, as well as the relationshipwith the surrounding community, are two factors that combine toease some of the complications normally associated with such achallenging endeavor.

What projects are already being done with KTB samples?

Some examples of questions that researchers are asking are: Whatis the difference between the normal breast and the cancerousbreast? How does the aging process change the breast? What kindof genetic links can be found with regards to breast cancer? Whatchanges happen to the breast during the process of pre-pregnancy,pregnancy, and weaning? Research involving these and otherquestions is currently being done; there are also completed projectsusing KTB tissue samples that have produced published papers.

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opportunity to advertise to the ISBER

membership throughout the year.

Ads appear in the newsletter issue PDFs

posted on the ISBER website, as well as in

any print copies produced for meetings.

www.isber.org/advertising/



New De-identification Guidance

Available

Repositories often remove identifying information beforedistributing specimens in order to maintain the privacy of theindividuals from whom the specimens were obtained and theconfidentiality of their data. Thus, de-identification is an importantand useful concept for human specimen repositories.

On November 26, 2012, the US Department of Health andHuman Services (HHS) Office for Civil Rights (OCR) issued newguidance about how to achieve de-identification in accordancewith the Health Insurance Portability and Accountability Act of1996 (HIPAA) Privacy Rule. In the US, the HIPAA Privacy Rulegoverns the uses and disclosures of protected health informationby “Covered Entities” (healthcare providers, health plans, andhealthcare clearinghouses). The recently issued guidance on de-identification under the Privacy Rule was developed from inputobtained from various stakeholders with practical, technical andpolicy experience in de-identification.

The Privacy Rule at Sections 164.514(b)(1) and 164.514(b)(2)provides two methods by which health information can bedesignated as de-identified. The “Safe Harbor” method at164.514(b)(2) involves the removal of 18 specified identifiers andthe Covered Entity must have no actual knowledge that theremaining information can be used alone or in combination withany other information to re-identify the individual. The secondmethod, the “Expert Determination” method at Section164.514(b)(1), involves an expert applying generally acceptedstatistical and scientific principles and methods to determine thatthe risk of re-identification is very small.

The new OCR de-identification guidance addresses both de-identification methodologies. With regard to the Safe Harbormethod, the document discusses when partial zip codes, partialdates and unique codes may be included in de-identifieddatasets and when covered entities would fail to meet the “actualknowledge” provision. It also provides additional guidance on theExpert determination method including the acceptable level ofidentification risk for an expert determination, how long an expertdetermination is valid for, and how experts assess the risk ofidentification of information. The complete text of the documentmay be downloaded from the HHS OCR website athttp://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html.

Marianna Bledsoe1

ISBER Past President, 2007 - 2008

1This article reflects the personal understanding of the author. It does notconstitute policy guidance nor does it represent the official position of the USDepartment of Veterans Affairs or the US government.

ISBER Corporate

PartnershipsHighlighting your products and servicesto the international specimen repository

community!

ISBER Organizational members

are invited to participate as

Corporate Partners. Corporate

Partnerships are designed to

provide our member

organizations additional high-

visibility opportunities to highlight

their company, products and

services at the Annual Meeting

and on the ISBER website. Partnerships provide

unparalleled opportunities to connect with professionals in

the specimen collection and storage industry in domestic

and international markets. Corporate Partnerships are

renewable each year and support the educational

initiatives of the Society through unrestricted educational

grants at three levels of support. Corporate Partners must

be an Organizational member of ISBER. ISBER is a

Division of the American Society for Investigative

Pathology (ASIP), a 501(c)3 not-for-profit organization.

We invite your company/organization to participate as an

ISBER Corporate Partner. If your company/organization is

not yet a member of ISBER, we encourage you to select

ISBER as your professional home, and participate as an

ISBER Corporate Partner.

www.isber.org/CP/Exhibit at ISBER 2013!

Download the ISBER 2013 ExhibitorProspectus at www.isber.org/2013/

Direct inquiries to Laurie Menser, Director of Marketing and Development

[email protected]: 301-634-7908



Hot TopicsReminder: These discussions are the biggest topics of interest on the ISBER ListServ.

#1 – CRYOSHIPPERS

Cynthia Ballion of Hamilton Regional Laboratory MedicineProgram at McMaster University asked this question: “Has anyonehad problems with cryoshipper shipping? That is, having them tiltedfor extended periods leading to loss of nitrogen, elevatedtemperature, and samples being compromised.” Michel Barnes ofCincinnati Children’s Hospital recommended dry storage cryogenicshippers designed to absorb LN2 and then out-gas VP-LN2 fromthe shipper walls. He noted, “These shippers also have theadvantage that they are not considered hazardous for shippingpurposes, since the LN2 is absorbed and there is no liquid to sloshout.” Richard Thorp of ILSBio said that they have several types ofportable LN2 freezers, and had these comments: “The standardshipping cases for some models are rectangular, which,unfortunately, encourages them to be laid down or even placedupside down in shipping. It seems that, no one ever reads to (sic)‘THIS SIDE UP’ labels. Other plastic shipping containers are shapedlike mushrooms. They come in all sizes, which makes it difficult forthe carrier to lay it down or ship it upside down. It is kind of like theold fashioned hump back trunks that savvy travelers used on shipsand in stagecoaches, and it’s impossible to stack other things ontop of them. Given the irreplaceable nature of these shipments, wefind it necessary to take every precaution.”

Yasmin Isler of Promedica Laboratories expanded the discussionby asking: “Currently the only location we would be shippingsamples to would be to an Academic location within the same citythat we are located in. Would shipping samples on dry ice besufficient for such short distance transportation?” Kelly Feil of theKellyn Group responded: “My recommendation is that you checkinto courier services in your city (regular couriers, not necessarilycold chain services). In many cases, you will find the costs to becheaper than overnight shipping of containers with dry ice via FedEx or similar and certainly cheaper than cryoshippers. You may alsobe able to negotiate a discounted rate if you plan to use the samecourier service on a regular basis. Finally, this approach also givesyou the advantage of having the samples delivered the same dayand eliminates the risk of them being delayed (beyond the smallwindow of a traffic jam) or misplaced. Using LN2 vs dry ice willdepend upon the circumstances of your end users. Will you beshipping a small number of samples or bulk shipments? Are thesamples rare or easily replaced? Will your end users be willing toincur the extra shipping costs? You want to make sure you ‘right-size’ the solution to your precise needs.”

#2 – SHARED BIOREPOSITORY PRACTICES

Dan Mercola, Director, Translational Cancer Biology at theUniversity of California at Irvine, CA, asked if anyone hadexperience in developing links among multiple biorepositories ofrelated institutions, whether public or within multi-site commercialenterprises. Kelly Feil described her experiences with theCooperative Human Tissue Network (CHTN) and working withUCSF and UC-Davis for the Chordoma Foundation Biobank.Svetlana Mihaylova-Todorova, of the IHS Biorepository Resourceat Maricopa Integrated Health System in Phoenix, AZ, pointed Danto the Arizona Biospecimen Locator (ABL)https://abl.azdhs.gov/tissuelocator-web/browse.action webpage, asan example of a centralized web-based biospecimen database oftissue stored at participating Arizona Hospitals. The goal is to postand share biospecimens that are in excess to what is needed forpatient care, or biospecimens collected for research but no longer

needed. Researchers (not affiliated with the participatinginstitutions) may use the site to browse, search and requestbiospecimens to use in qualified studies. A standardized ArizonaBiospecimen Consortium MTA is in place.

Going a little further, Nannan Yang of the University of Tromsø,Norway, asked about quality control protocols. Brent Schacter ofthe Canadian Tumor Repository Network (CTRNet) project, advised:“You should check the SOPs, freely available on the www.ctrnet.cawebsite.” (http://www.ctrnet.ca/operating-procedures)

#3 -STORAGE OF SPECIMENS AT -80°C VS VP-LN2

(This topic was really lively, and is one of great current researchinterest.)

Emma Raymond from Ventyx Wesley Research Institute askedwhether storage in -80°C or VP-LN2 was preferable.

Ashley Highfill of the Kansas University Medical Center replied:“For long-term storage, say many years, bio-markers and proteinsare more stable in -180°C than -80°C. This is what my directorpreaches. Also, with vapor phase liquid nitrogen, if the freezer fails,you have a much greater amount of time to address the issue if thefreezer has a good seal(couple of days realistically) than if a -80°Ccompressor goes out (hours). Also, you just have to worry about thecomputer going out on the LN2 freezer, where you have to worryabout the compressor going out with the -80°C units (which can bealmost as expensive as the freezer). [Mechanical freezers] have alifespan of 10 years on average; LN2s last much longer. I think thoseare very big proponents for liquid nitrogen.”

Sarah Dry, UCLA Department of Pathology Director, crystallized thedifficulty with this issue, though: “Until such time that published,peer-reviewed references are found, I would respectfully ask thatwe stop saying (on this ListServ and elsewhere) that liquid nitrogenis better than -80°C storage for biosamples. We are entering a newera of biorepository standards and accreditation (already started byCAP), as well as a new era of examining the reliability of researchdata based on how biospecimens were handled prior to researchuse. In this climate, there is a risk that these statements, if said byenough people, become seen as fact, even if there is no data tosupport them. This in turn leads to the risk of influencingbiorepository standards/accreditation requirements or ofdetermining that some samples are "unsatisfactory" for research. Ifthis were the case, many biobanks may need to get rid offunctioning freezers and make expensive investments in newequipment, and some biosamples may unnecessarily be consideredunacceptable for certain types of research. Furthermore, it ispossible that not all biobanks may have reliable access to liquidnitrogen, versus a plug for a -80°C, and thus may not be able toachieve accreditation if standards were changed. When and if harddata emerges that one of these methods is better than the other,then of course we will need to re-examine our practices accordingly.”

Joe Galbraith of the University of Iowa replied: “This is a questionfor which everyone is waiting for experimental evidence to supportan appropriate answer. As you may already know the argument maytheoretically hinge on the concept of the glass transition temp ofwater at around -132°C. Storage at colder temps may or may notfurther retard degradation of specimens (particularly fresh frozentissue) better for instance when LN2 vapor temps of around -185°Cbut the data to support this is (sic) not yet available though I havespoken with researchers and companies that have long term experiments currently underway to test the validity of the hypothesis.

(Continued on page 12)Hot Topics



Hot Topics(Continued from page 11)

Long term storage may prove more effective at the colder tempsbut we are all awaiting the proof.“

Rebecca Pugh of the Hollings Marine Center Marine MammalsBiorepository in Charleston, SC, provided this sample stabilityreference: Anulacion, B.F., B.D. Bill, and T.K. Collier. 1997. Stabilityof cytochrome P4501A-associated enzyme activity in cryogenicallystored teleost liver samples. Chemosphere 34:2029-2039.

Fay Betsou, Chief of Biospecimen Science at IBBL, added:” Thereare very few evidence-based data on blood analytes which areunstable at -80°C. Because residual molecular Brown movementpersists at -80°C, some enzymatic activities might decrease overtime and some proteolysis might take place. Protein S activity inplasma decreases after years of storage at -80°C. MMP9 in plasmaand VEGF in serum have been shown to degrade after prolongedstorage at -80°C. The same [is true] for some cytokines in serumand plasma (IL1b, IL10, IL15).

For some analytes, including vitamins, we know that they areunstable at -20°C, but we don't know if they are unstable at -80°C;if we trust Arrhenius logic, much slower degradation at -80°C couldtake place for these analytes (but no real time stability data areavailable!) You can find all the references that the BiospecimenScience Working Group has put together on the ISBER website.There is also a publication which will soon come out in J Mol Diagnon this subject (the reference will be posted on the ISBER websitevery soon). As a conclusion, with today's knowledge, -80°C can beconsidered a reliable storage temperature, for storage durations inthe order of magnitude of years. When it comes to storagedurations in the order of magnitude of decades and centuries,measurement of few molecules and of some enzymatic activitiesmay become inaccurate.”

Helen Moore of NCI BBRB, forwarded this response from Kelly

Engel, lead literature curator for the NCI Biospecimen ResearchDatabase (BRD; http://brd.nci.nih.gov): “BBRB is actually draftinga review paper on variables associated with snap freezing tissuespecimens. Similar to what others have shared, I have not beenable to locate any papers that specifically compare the stability ofanalytes at -80°C versus liquid nitrogen over a prolonged period.

I have been able to locate a few papers comparing the stability ofvarious analytes at -70 or -80°C versus liquid nitrogen for shortdurations (the longest duration examined was 21 days). Generally,the two temperatures produced equivalent results for short-termstorage (McLeay 1992; Mackey 1999), although it's important tonote that specimens shipped in liquid nitrogen produced superiorresults to those shipped on dry ice (Muschenheim 1978). As I'vecome to learn, there are several subtle variables associated withstorage in liquid nitrogen versus an ultra-low freezer, includingcontamination risk and differences in temperature fluctuations dueto the size and type of freezer (chest versus upright), the locationof the specimen within the freezer, and how many times the freezeris opened. Each method seems to have its own pros and cons.There are also additional papers comparing methods of initialpreservation, where differentially cryopreserved specimens werestored at -80 degrees C until analysis. Data from these types ofstudies suggest that, with the notable exception of morphology(where liquid nitrogen vapor was superior), analytes wereequivalent when preserved at either -80°C or in liquid nitrogen orliquid nitrogen vapor.

I've included the full citation for those papers comparing the effectsof short-term storage at different temperatures below as well as alink to the BRD curation page, which includes a summary and alinkout to PubMed when applicable.

Hope this helps and we look forward to sharing the final results ofour meta-analysis

1. McLeay, W.R., et al., Epidermal growth factor receptor in breast cancer: storage conditions affecting measurement, and relationship to steroid receptors. Breast Cancer Res Treat, 1992. 22(2): p. 141-51.http://brd.nci.nih.gov/BRN/paperStudyDetails.seam?paperId=10309

2. Mackey, E.A., et al., Quality assurance in analysis of cryogenically stored liver tissue specimens from the NIST National Biomonitoring Specimen Bank(NBSB). Science of the Total Environment, 1999. 226(2-3): p. 165-176.http://brd.nci.nih.gov/BRN/paperStudyDetails.seam?paperId=10665&cid=94756&dataModelSelection=paper%3AsearchResults%5B0%5D

3. Muschenheim, F., J.L. Furst, and H.A. Bates, Increased incidence of positive tests for estrogen binding in mammary carcinoma specimens transported in liquid nitrogen. Am J Clin Pathol, 1978. 70(5): p. 780-2.

http://brd.nci.nih.gov/BRN/paperStudyDetails.seam?paperId=11543

Finally, in addition to the references being compiled by the ISBERBiospecimen Working Group, Sarah Dry reminded us about thisresource: Dr. Alison Hubel of the University of Minnesota BioCoRis also compiling a bibliography on effect of storage temps ondifferent biosamples. She currently has an extensive workingbibliography on storage temperatures. Alison said: “We getrequests on a regular basis from individuals or organizationswanting to know the 'correct' temperature for storage of a biologicalsample (proteins, cells, tissue, and nucleic acids). As a result, weare starting a working bibliography on the influence of storagetemperatures on stability of a preserved biological samples. If youhave written or are aware of studies in which different storagetemperatures are evaluated, please send us ([email protected])the reference or an electronic version of the paper and we willcollate this information and pass it on via BioCoR's library. We havestarted the bibliography and will be posting it in the library andupdating it regularly.”

And on a final note, a BUNCH of discussion was generated on theListserv starting the week of December 10th after member Lizzi

Neylon of the Phoenix Children’s Hospital won our prize for mostresponses generated in 2012 (and they’re still coming in!) when sheasked about recommendations for purchasing -80°C mechanicalfreezers. Members responded immediately about problems theyhad encountered. Bottom line: if you have had problems with thecompressors of certain models of recently purchased -80°Cmechanical freezers, contact the manufacturer ASAP forreplacement service!

Get to Know ISBER

Learn about ISBER from thepoint of view ofmembers andmeeting attendees! Watch the Video!

www.isber.org/youtube/



5th Annual Beaumont Biobank Symposium:

Forming a Great Lakes Biobank NetworkThe announcement of a pending merger of two major health systems by Dr. Ananias

Diokno, CMO of the Beaumont Health System, gave special meaning to this year’stheme to the Beaumont Biobank Symposium: Forming a Great Lakes Biobank Network.

The merger of the William Beaumont and Henry Ford Health Systems will create thelargest hospital system in Michigan and one of the tenth largest in the nation. Accordingto Dr. Diokno, a strong collaborative area will be translational research. He said, “Theforming of a Great Lakes Biobank Network would fit in nicely in these plans. Thisnetwork, that will bring the large institutions together around emerging research fieldslike biobanking and translational research, will truly help us build relations in the region.”

The symposium ended with a panel discussion that led to a verbal manifesto for theregion to move forward with a Great Lakes Biobank Network, and an executivecommittee will be formed to develop a plan to get the network going.

According to Dr. Jan Akervall, Clinical Directorof the Beaumont Biobank at Royal Oak,Michigan, the goals of building a Great LakesNetwork of Biobanks “are to enhancestandardization of specimen handling andintegrity, increase collaborations, share costsand strengthen the region as a major player inthe emerging field of biobanking.”

The effort to share costs fits in well with theremarks by keynote speaker Dr. Scott Jewell

of the Van Andel Institute (and formerPresident of ISBER), who noted thatbiobanking and biorepositories have becomemuch more expensive to operate due tosignificant changes over the last decade.

“Translating research for personalizedhealthcare is a key component in the future ofbiobanking, but how the biobank operates tomaintain a sustainable value to its institution isa key issue,” Dr. Jewell said, noting that“sustainable revenues” are an importantelement to maintaining a successfulbiorepository.

The speakers at the Symposium were allinvited to discuss:

1. Biobank models; 2. Ethical issues; 3. Specimen integrity; 4. How to bridge biobanking to

translational research.

About the William Beaumont Biobank

William Beaumont Biobank has beenoperational for 5 years, and is an integratedbiorepository and core molecular laboratory fortranslational biomarker studies. It has growntremendously over its 5 years, and now has60,000 samples collected from 45 investigatorsin 14 specialties. The Beaumont Biobankoperates independent of special interests fromresearch groups or departments and focuseson investigator-driven translational research “incontrast to traditional grant driven, translationalresearch,” according to Dr. Akervall.Investigators can get assistance with manyaspects of research, such as approvedconsenting processes and documents, labanalyses of biomarkers, or manuscript writingthrough the Biobank. The model is designedfor a private academic center where physiciansmay not have protected research time, but itcould be applied to community and pureacademic centers as well, since it is dynamicand can be adjusted to any scientific needs.The effort to build a Great Lakes Network ofBiobanks is to enhance standardization ofspecimen handling and integrity, to increasecollaborations, to share costs and strengthenthe region as a major player in the emergingfield of biobanking.

Staff of the Beaumont Biobank in Royal Oak, MI

Scientific panel discussion: Dr. George Wilson at podium, Dr. Jan Akervall (left), Dr. Thomas Tomlinson(center), Dr. Scott Jewell (right)



SeraCare Bioservices is Now Precision

Bioservices, Inc.I am very excited to announce that theSeraCare Bioservices repository will nowbe Precision Bioservices, Inc, a whollyowned subsidiary of Precision HealthHoldings. Precision Health is committedto the advancement of PersonalizedMedicine by supporting the life sciencescommunity to accelerate developmentand commercialization of individualizedmedicines and targeted therapeutics.

Precision Health shares the same values we do and exceededour hopes for a company we can combine with. Together, weare committed to continue the tradition for excellent service,deep expertise, and an environment our clients and associateswant to be a part of.

Kathi SheaVice President, Bioservices OperationsPrecision Bioservices, Inc

Andy Zaayenga Uses Creative Technology to

Survive During Superstorm SandyOur resident ISBER Technocrat, Andy Zaayenga, used hisfaithful Prius hybrid automobile to help his family surviveduring the Hurricane Sandy, the Superstorm that ravaged theNew York City and New Jersey coastal area. Andy’sFacebook page chronicled their struggle: “Sweet Prius,powering the house through day 9 of no power and anor'easter at under 7 ounces of gas per hour... ” It poweredtheir refrigerator, computer TV, FIOS, phone, network, andsome lights, using at peak only 400 out of 1000 potentialwatts, thus letting Andy save the portable generator for morecritical uses such as water refills and showers – importantwhen few gas stations were open and purchase lines werefour hours long.

Andy also directed readers interested in this process to anexcellent NBC News how-to article with valuable safety

information: http://editorial.autos.msn.com/blogs/autosblogpost.aspx?post=7f887013-60d3-4465-a14b-6bbf588c03bc(“How a Prius can power your home in an outage - At leasttwo resourceful hybrid owners were able to watch TV whiletheir neighbors were stranded in the dark during theblackouts after Sandy.”)

For another commentary on how the research communitywas affected, see: “NYC Science Stunned by Sandy”(http://www.the-scientist.com/?articles.view/articleNo/33109/title/NYC-Science-Stunned-by-Sandy/) and “Sandyvs. Science: On Long Island, Prominent Research LabWeathers the Storm” (http://news.sciencemag.org/scienceinsider/2012/11/sandy-vs-science-on-long-island-.html).

UF CTSI Biorepository Achieves

Accreditation From College of American

PathologistsOn November 1, 2012, the University of Florida Clinical andTranslational Science Institute (CTSI) Biorepository(http://biorepository.pathology.ufl.edu/) became the 12thbiorepository to achieve College of American Pathologists(CAP) accreditation based on results of a recent on-siteinspection. The facility’s director, Michael J. Clare-Salzler,

MD, was advised of this national recognition by CAPPresident, Stanley J. Robboy, MD, FCAP, and wascongratulated for the excellence of the services beingprovided.

The UF CTSI Biorepository was conceived in mid-2009 andhas undergone a tremendous evolution over the last coupleof years in order to fulfill the mission of providing extensivebiobanking infrastructure to support translational researchconducted by investigators at UF and beyond. It provides avariety of services, including the creation of an institutionalbiospecimen library as well as tissue procurement andstorage for investigator-led studies, such as a national agingtrial involving 10 sites across the U.S. for which thebiorepository manages 252,000 aliquots. The goal of the UFCTSI Biorepository is to ensure the highest qualitybiospecimens through adherence to strict operatingprocedures, redundant and automated storage, inventorytracking, and emergency response planning. It is also closelyintegrated with other institutional resources, including the UFacademic health center’s integrated data repository and asystem-wide consent process through which patients canallow the UF CTSI Biorepository to store biospecimensleftover from their healthcare visits for future use in research.

The Biorepository houses equipment for storage, processingand sample tracking, and equipment temperature monitoring.Samples are stored in automated sample managementsystems (2) or manual freezers (8) at -80°C with either CO2or LN2 back-up, emergency power back-up, and a 24/7/365

remote monitoring system. Liquid nitrogen storage will be

developed to expand the infrastructure and cell storage

Smart Moves

(Continued on page 15)Smart Moves



capabilities of the Biorepository, which also has equipmentfor both small volume DNA, RNA and protein purification andfor quality-control analysis. The samples stored within theBiorepository are securely managed using a web-basedLaboratory Information Management System (LIMS), andinformation regarding availability of samples is accessiblethrough the university's integrated data repository. The LIMSsoftware supports all aspects of biospecimen managementincluding tracking of patient consent, collection andannotation of biospecimens, storage location and quantity,capture of quality assurance data, and distribution of samplesto ensure proper chain of custody. The databasemanagement system also allows comprehensive searchesand has reporting features that provide flexible biospecimenreporting capabilities. The Standard Operating Proceduresused by the Biorepository are managed using an electronicdata management system and are based on the best-practice guidelines set forth by ISBER and the NCIBiorepositories and Biospecimen Research Branch (BBRB).The desire to provide the highest quality biospecimens ledthe UF CTSI Biorepository staff to seek accreditation by theCollege of American Pathologists.

The CAP Biorepository Accreditation Program is based onthe principles of its Laboratory Accreditation Program. It is athree-year accreditation cycle, including an on-siteinspection, desk review, and optional education modules andgap assessment. As part of the on-site inspection, the CAPuses Accreditation Checklists to provide a comprehensiveand up-to-date blueprint of quality practices to assistbiorepositories in improving their operations and ensurequality. Further, a desk review offers a remote review of abiorepository’s quality management plan, certain proceduresand select quality and process statistics. The U.S. federalgovernment recognizes the CAP Laboratory AccreditationProgram, begun in the early 1960s, as being equal-to ormore-stringent-than the government’s own inspectionprogram. Currently, there is no federal mandate forbiorepository accreditation.

ISBER has been working closely with CAP on this program.At the May 2012 meeting in Vancouver, ISBER memberswere invited to be trained as inspectors for this programand do the following:

n Lead a CAP inspection team,n Discover, synthesize, and assess processes to a

requirement, andn Understand the philosophy of CAP inspections

and deliver the value of CAP Accreditation to the biorepository industry.

Mark Cosentino - Director of

Biogen BiobankLong-time ISBER member (Louis) Mark

Cosentino has accepted a position withBiogen Idec, the oldest independentbiotechnology company in the world,making products for the treatment ofmultiple sclerosis and new therapies forpatients with neurodegenerativediseases, autoimmune disorders andhemophilia. Mark will serve as Director ofthe Biobank for Translational Medicine at

the Biogen Idec facility in Cambridge, MA. Previously Markwas Project Manager for the Central Repository, Head of theBioprocessing Laboratory, & Head of the DNA ExtractionLaboratory at the SAIC Biorepository facility in Frederick, MD,working on many biorepository projects for NCI.

Brett Roberts Promoted to the Position of

Commercial Director for Bluechiip, Ltd, of

AustraliaBluechiip (an ISBER Platinum CorporatePartner) offers a proprietary Radio FrequencyIdentification (RFID) system, including chipsand an interrogator system that will providecustomers with key functional advantagesthat cannot be met by alternative RFIDtechnologies. At Bluechiip, Brett isresponsible for planning, controlling andmanaging sales, marketing and businessdevelopment activities. He is an experiencedsenior leader with a track record of deliveringresults in complex and challengingenvironments across a broad range of

industries. (Read more at http://www.bluechiip.com/about-us/team/brett-roberts/)

ISBER Corporate PartnershipsHighlighting your products and services to theinternational specimen repository community!

Corporate Partnerships are designedto provide ISBER memberorganizations additional high-visibilityopportunities to highlight theircompany, products and services atthe Annual Meeting and on theISBER website.

Partnerships provide unparalleledopportunities to connect withprofessionals in the specimencollection and storage industry indomestic and international markets.

www.isber.org/CP

Smart Moves(Continued from page 14)

Brett Roberts

Mark Cosentino

Get Involved...Join an ISBER

Working Group!www.isber.org/wg/

ISBER Working Groups are organizedaround imely, challenging issues relatingto biobanking. They are composed ofindividuals with expertise and experiencein the subject areas and who arecommitted to producing outcomes to the

discipline of biobanking.

Current Working Groups

n Automated Repositoriesn Biospecimen Sciencen Environmental Biospecimenn Hospital-Integrated

Biorepositoriesn Informaticsn Informed Consent Procedures for

the Collection of Biospecimensn International Repository Locatorn Pharma-Academian Rare Diseasesn Rights to and Control of Human

Tissue Samples

Contact information for ISBER WorkingGroup Organizers and complete details aboutissues currently being addressed by thesegroups is available on the ISBER Website. Ifyou are interested in getting involved with aWorking Group, please contact the Group’sOrganizer.

www.isber.org/getinvolved



Make your Tax-Deductible Contribution to theISBER Global Expansion Fund!

Since its creation in 2007, the ISBER Global Expansion Fund hasbeen used to support ISBER’s effort to increase ISBER’s world-widemembership and presence. One of the major goals of this effort hasbeen to provide annual financial sustenance for the ISBER TravelAward, which provides travel support for individuals from emergingcountries to attend the ISBER Annual Meeting. Since 2007 the fundhas provided support to scientists from Nigeria, Colombia, and Sudan.This year, our goal is to raise at least $6,000 specifically to fund theISBER Travel Award. We ask our ISBER members to support thiseffort. To learn more about the ISBER Global Expansion Fund or toread reports from ISBER Travel Award recipients about theirexperiences attending the ISBER Annual Meeting, visit:http://www.isber.org/global.html. From this page you can also easilymake a secure online donation or download a printed form that canbe returned to the ISBER Office.

Thank You to Our Current Donors!We gratefully acknowledge the 2012 donors to the ISBER GlobalExpansion Fund.

Roger Aamodt

Bonginkosi Duma

Elaine Gunter

Susan Hilsenbeck

Paula Kim

Miral Patel

Francesca Poloni

Kaj Henrik Rydman

Jim Vaught

We would also like to acknowledge the contributions of the 2012

Annual Meeting 5K Fun Run/Walk sponsors and registrants along

with the meeting attendees who participated in the 50/50 drawing.

ISBER is a division of ASIP, a non-profit educational 501(c)(3)organization under US tax law and can accept tax deductiblecharitable contributions. Therefore your contribution to the GlobalExpansion Fund is tax deductible under current IRS regulations aswell as the regulations of some other countries. Please consult yourtax accountant for specific information about the tax deductibility ofyour contribution.

Financial support is just the tip of the iceberg. Over the past year manyISBER members have supported us in a host of ways, as volunteers,mentors, sponsors and partners. We acknowledge your invaluablecontributions with appreciation and gratitude. Thank you for helping tomake ISBER a place where groundbreaking research, innovativeteaching and cutting-edge technology come together to produce theworld’s biobanking leaders – like you!

James DouglasISBERChief Operating Officer



ISBER Members Help Save Precious Samples at

New York City Biorepositories

Indianapolis-Based Biorepository Leads

Hurricane Sandy Disaster Recovery

EffortsBy Meredith Formsma, MBA, BioStorage Technologies, Inc.

In the aftermath of destruction due to Hurricane Sandy, thousands ofrefrigerated and frozen biological samples, decades of research, wereat risk of being lost or destroyed because of the loss of power in theManhattan area due to the storm.

Immediately upon learning of the power outages, sample managementindustry leaders at BioStorage Technologies knew it was one of only afew companies with the capabilities of rescuing these research samples.By having the operational resources, mobile biorepository vehicle andstaff with the ability to save research samples including blood, tumortissue and infectious disease agents, it was an easy decision toproactively send expert disaster recovery teams to New York City.

BioStorage Technologies’ Chief Executive Officer Gregory Swanberg,

MBA put into action the company's mobile biorepository to New YorkCity, and what unfolded was a disaster recovery mission for not only thegood of the scientific community, but the world.

It was the first time the BioStorage Technologies' Relofleet® truck, sinceits inception less than three years ago, was used in a natural disasterrelief effort. The high-tech mobile biorepository is capable of transportingthousands of samples with varied temperature storage requirements,ranging from liquid nitrogen phase to room temperature.

"It really was an easy decision for us," says Swanberg. "We knew [losingthe samples] would be devastating for science, and ultimately couldimpact our biopharmaceutical clients——because these [samples] arethe early-phase research samples that support the research to producethe pharmaceutical therapies of tomorrow. Many of the samples requirespecial handling, and with the capabilities of our truck, we knew we wereone of the few companies in the world that could help them."

Swanberg made a call to Manhattan-based business partner Andy

Brooks, PhD, chief operating officer of RUCDR Infinite Biologics atRutgers University Cell and DNA Repository—which was weatheringthe storm—to see who else needed help; RUCDR provides

Disaster Planning for a High Rise

SocietyBy Alan Davis, Novare, LLC

In October, Superstorm Sandy slammed into the UnitesStates’ East Coast, impacting nearly 20 percent of thecountry’s population and causing billions of dollars in damageand losses. New York City was one of the hardest hit regionswith extensive power outages and flooding, wreaking havocon medical institutions throughout the area. Vivariums andbiological sample collections that took decades to build weredestroyed, and the impact on our research community willcertainly be felt for many years to come.

Researchers at New York University (NYU) reporteddevastating losses on campus including the destruction ofhundreds of thousands animals and biospecimens being usedfor research. While backup generators were in place toaccount for power outages, no one anticipated majorbasement flooding would cause fuel pumps to fail, renderingthe generators useless. The difficulty in transporting liquidnitrogen and dry ice to research facilities on the 17th floor ofbuildings with no operational elevators was alsounderestimated. Sufficiently icing every freezer proved to beimpossible. Many specimens were lost forever.

Superstorm Sandy reiterated the importance of disasterplanning for any repository, and the value of ISBER’s BestPractices for creating recovery/incident plans that can betested and practiced through simulated emergencies.However, it also brought the unexpected and unprecedentedto the forefront.

Rescuing Precious Samples at the NYU Dental School

NYU’s College of Dentistry is the largest dental school in thenation and implements a synergistic translational researchstrategy to move fundamental basic science discoveries intopractice. Its collections include an eight-year longitudinal studyon twins followed since birth (that still actively collectssamples), a large collection of specimens from paired mothersand their children, and a six-year longitudinal study examiningoral flora in HIV patients pre- and post- highly activeantiretroviral therapy (HAART). Such, collections are trulypriceless and irreplaceable. Additionally, many of their sourcespecimens are not extracted until ready for analysis andrequire storage at -80°C. Oral plaque samples, saliva andbiopsy tissues collected for microbiome and proteomicanalysis would all be rendered useless if thawed for even ashort period of time.

Leading up to and during the Superstorm, Louis Terracio,

PhD, Vice Dean for Research at NYU College of Dentistry,and his colleagues initiated an emergency plan for providingsufficient dry ice to the freezers for a 24-hour period (they werenot equipped with an electric generator). Unfortunately,

BioStorage Technologies Relofleet mobile biorepository arrived at the NYU MedicalCenter

(Continued on page 18)BioStorage Technologies

(Continued on page 20)Novare



BioStorage Technologies(Continued from page 17)

lab processing services for BioStorage Technologies' clients. At thetime, three medical centers in Manhattan, NYU Hospital, BellevueHospital, and Veterans Affairs (VA) Hospital—all partners ofRUCDR—were evacuating as water poured in and power failed.

"The moment they started moving thousands of patients to otherhospitals and medical centers, we knew there was going to be aproblem with all of their biological and clinical samples," saysBrooks. "I was concerned from a researcher's perspective;collectively between those three institutions, you've got a couplehundred years' worth of research and very important samples."

Though the centers represented only a loose business connectionat best (partners of a partner) BioStorage Technologies dispatchedits Relofleet® truck and a team of eight employees to the Manhattanhospitals at its own cost.

"Manhattan was absolutely off the grid," says Swanberg. "It tookalmost a day of Dr. Brooks’ coordination efforts just to be able to geta large semi into New York City; as you can imagine, everyone elsewas exiting. The tunnels were down and flooded, many of thebridges were out or going through structural engineering reviews,and our rental car filled with employees ran out of gas, it was alogistics nightmare."

Once it finally arrived, the truck and BioStorage Technologies teamwere immediately put to work rescuing samples from the VAHospital—a process Brooks knew was physically possible butpresented some significant challenges.

"We had to climb 18 stories in a high-rise that had no power, so nolights, and move tens of thousands of samples and freezercontents," says Brooks. "The samples had been kept cold after theylost power by the investigators, who had been climbing the stairsfor a couple days putting dry ice in the freezers. We were carryingthis precious biomaterial, including infectious biomaterials, and celllines that are irreplaceable down 18 stories of this Manhattan high-rise."

With the help of the BioStorage Technologies operations team,RUCDR staff and 100 volunteers, the samples were cataloged,

loaded into "bunker" carts, and moved to the Relofleet truck fortransport to RUCDR Infinite Biologics inland facility or thecompany's Indianapolis-based headquarters.

"We were in the dark at just about all of the institutions," saysBrooks. "We had to rescue samples from inside Bellevue, and allthe patient rooms were empty. Linens were all over the place. Itlooked like everybody just rushed out of there. It was very eerie;there are usually thousands of patients there, and it was empty."

After almost three days of around-the-clock work, Brooks says "wewere able to get it done," and the most critical samples wereretrieved from all three hospitals. Since the original action plan,BioStorage Technologies says the Relofleet® truck has made threeround-trip drives to New York City, including extra stops in variouscities to pick up additional freezers and supplies.

"It was an incredible effort, and the truck will make numerous tripsback as we repatriate those samples back to the scientists," saysSwanberg. "Part of our mission is to be an enabler for science; we'refulfilling our mission here. These scientists aren't doing this researchfor financial gain; they're doing it as a life calling to try to betterscience."

By the same token, Swanberg says the company provided itsservices not for financial gain, but to support the research industryby saving invaluable samples that could have been a devastatingloss to science.

Relofleet® was power equipped to store samples within freezers and bunkers of dryice.

BioStorage Technologies sample management experts worked fast to store andtransport research samples.

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INTERNATIONAL SOCIETY FOR BIOLOGICAL AND ENVIRONMENTAL REPOSITORIES

ISBER 2013 Annual Meeting & ExhibitsTurning the World Upside Down: Emerging Perspectives on Biorepositories

May 5-9, 2013Sydney, Australia

We invite you to join us for the International Society for Biological and Environmental Repositories(ISBER) 2013 Annual Meeting, May 5-9, 2013 in Sydney, Australia. The Program Committee hasbeen working hard to plan a comprehensive program which we hope will encourage dialogue anddiscussion amongst attendees. We look forward to interacting with ISBER members from allcorners of the World! This meeting will feature plenary sessions, educational workshops,corporate workshops, contributed papers, poster sessions, and working group discussions.Vendors from around the world will demonstrate the latest products, services, and technology inthe field of repository and specimen collection.

The ISBER 2013 Annual Meeting & Exhibits will be held at the Sydney Convention & ExhibitionCentre, conveniently located in the heart of the city within close proximity to Darling Harbourand many other major attractions. Plan now to attend this premier event in the field of repositoryand specimen management. Meet with your colleagues from around the world and view thelatest technology and equipment in the specimen collection and repository industry!

Session topics are expected to cover, but are not limited to the following areas:• Turning the World Upside Down: Cutting Edge Biorepository Developments • Emerging and Cross-Cutting Issues • New Biological Perspectives in Biospecimen Science • Securing Components of our Natural World • Innovative Technologies • Late Breaking International Policy Issues and Global Harmonization Efforts

Related to Biobanking• The Nagoya Protocol and its Implications for Biobanks • Biobanking for Translational Science: Mobilizing Research Specimens for Action

www.isber.org/2013

Advance (Reduced)Registration Deadline

March 5, 2013



Give the Gift

of Knowledge

to Your

Customers!

ISBER now offers

Bulk Memberships!



Bulk Memberships are available to ISBERMembers wishing to provide complimentarymembership in ISBER to their customers andclients. The ISBER Bulk MembershipProgram provides you with the opportunity topurchase DISCOUNTED memberships inpackages of as few as five memberships at atime. You can then gift these memberships toyour clients and customers.*

*Bulk Memberships can only be gifted to NEW ISBERmembers. Some restrictions apply.

For complete program details, contact LaurieMenser ([email protected]).

Novare(Continued from page 17)

the vendor had no drivers available so faculty and staff picked iceup themselves in their personal vehicles. When supplies diminished,they resorted to obtaining ice from trucks on the street, payingexorbitant prices in cash (US $2,400 for 1,000 lbs), and breakingup blocks manually. While this process allowed them to ice the 28freezers on campus prior to losing power and maintain thetemperature of their specimens for 24 hours, it was not sustainable.

Meanwhile, a local professional repository, Novare, had also beenplanning for the storm by ordering ice, topping off LN2 and fuel,bringing a truck from California, scheduling staff for 24/7 on sitecoverage , and working to provide secure specimen storage andredundant backup systems for many New York research institutions.These pre-planning efforts allowed them to keep their own storedspecimens unaffected and put them in a position to help the NYUCollege of Dentistry.

Novare assembled emergency supplies, a team of biologicalspecimen moving experts, and a moving company to safely relocateNYU College of Dentistry’s irreplaceable collections. According toDr. Terracio, they would not have been able to maintain theirspecimens for much longer without help. “Novare saved our mostcritical samples. They were responsive to us under the most difficultof circumstances when no one else would even return a phone call,”Dr. Terracio said. The College’s collections remain stored inNovare’s facilities while their campus recovers from the storm.

Lessons Learned

Overall, we can learn multiple lessons from Superstorm Sandyand the damage done to repositories up and down the EastCoast.

n Ensure that freezers and all components of emergency backup equipment are in locations not susceptible to flooding

n Keep emergency supplies accessible when utility and backup power is not available

n Have accessible cash for getting supplies while in a state of emergency

n Prospectively split collections and store a portion at a different location to avoid complete loss if your facility isrendered unusable.

n Establish relationships with professional repositories that allow for transfer of collections if your facility is compromised for an extended period of time

Better Mousetrap: Calculating Sample

Volume Using Weight

The Social & Scientific Systems, Inc. (SSS) repository andprocessing laboratory in Durham, North Carolina, serves multiplecontracts for receiving, aliquoting, and tracking biospecimens andenvironmental samples. A critical role is to ship frozen samples tovarious analytic labs for testing. Generally, the analytic labs specifythe minimum volume required for analysis and SSS selects samplesthat meet the volume/mass requirements. The analytic lab will thawand mix the samples, remove volume required for analysis, performthe testing, and return the frozen remainders to our repository. Thereare times when the testing lab removes multiple samples from a vialin order to perform intended duplicate tests or repeat a test due toQC problems, sampling error, etc. It is problematic to accuratelydecrement the returned vial amount when the lab either does notreport the volume of the remainder or does so inaccurately. Theissue becomes even more critical when small samples collectedfrom pediatric, elderly, or seriously ill study participants are usedand the principal investigator is concerned with maximizing thefuture research use of those samples. To those ends our staffdecided to research a method to accurately record the volume of afrozen biological sample.

In order to solve this problem SSS developed a volume-determination methodology where the returned frozen sampleswere weighed on an A&D GH-200 analytical balance that wasdirectly connected to a computer using the vendor supplied softwareto determine the volume of frozen sample in each vial. The methodwas simple and required that the samples spend a maximum of 15seconds out of dry ice. .

Testing Procedure

Setup• Weighed 10 empty Nalgene 5.0 ml cryovials (5000-0050)

and calculated the average weight • Weighed 10 empty Nalgene 5.0 ml cryovials with the same

labels used on the vials we were measuring. An average weight of 3.043g was calculated for the Nalgene 5.0 ml cryovials with the labels.

• Aliquotted 3 sets of serum with volumes ranging from 250 ul to 3.6 mL(250 uL increments, except after 2500 ul because of pipet)into vials with labels.

Weighing• To obtain a baseline of known volumes for comparison, we

weighed 10 x 3 sets of labeled Nalgene 5.0ml cryovials with increasing volume of unfrozen commercially acquiredserum (3 sets of serum at each volume between 250 ul to 3600 ul) at room temperature. We obtained an average for each volume then subtracted the tared weight (3.043g)of the cryovials from each average weight. The volume ofserum in each cryovial was then calculated by comparing the remaining weight to volume pipetted using a blood serum density of 1.0235 g/ml . The 3 sets of serum samples were then placed in a -80°C freezer overnight.

• It is critical that temperature fluctuations and warming be minimized when working with serum and plasma samples.With our first weight experiment we placed a small insulated container filled with dry ice on the analytical balance to maintain the temperature of the samples as they were weighed. The frozen serum vials were placed on top of the dry ice for weighing but they gained weight rapidly as water condensed on the dry ice. The weight continually climbed making an accurate measurement impossible.

• The 30 frozen serum cryovials, kept on dry ice when not being weighed, were weighed after wiping off the frost andplaced directly on the scale (ambient). The average weightfor each volume set was calculated and the weight of the cryovials (3.043g) was subtracted (tared) from each average weight. The volume of the serum was calculatedby comparing the remaining weight to a blood serum density of 1.0235 g/ml. The samples spent a maximum of 15 seconds out of dry ice for each weight measurement.

Figure 1: Comparison of the pipetted serum volume to thecalculated volume of the serum at room temperature and thecalculated volume of serum frozen at -80°C.

Figure 2: Chart of the pipetted serum volume compared to thecalculated volume of the serum frozen at -80°C (Average STDEV= 0.200).

Nick VernaLab ManagerSocial & Scientific Systems,Inc.

Mary WatsonStudy ManagerSocial & Scientific Systems,Inc.

(Continued on page 22)Calculating Sample Volume



Calculating Sample Volume(Continued from page 21)

Conclusions• Overall, average total weight of sample (minus tared

weight of tube/label ) was very close to the expected weight based on pipetted volume regardless of whether sample was weighed 1) unfrozen at room temperature or2) frozen and measured at ambient temperature.

• Unfrozen serum samples weighed at room temperature weighed 100% of the expected value on average.

• Frozen serum samples with frost wiped off and then weighed ambient on scale weighed 97.3% of the expected value based on aliquotted amount.

• Frozen samples were out of the dry ice bucket for a maximum of 15 seconds during the weighing process and should have minimal impact on the temperature of the sample.

i Sniegoski, l; Moody, J, Analytical Chemistry, Vol. 51, No. 9,August 1979, 1577, Determination of Serum and Blood

Densities

Self-Assessment Tool (SAT) forISBER Best Practices

ISBER has created this online Self-Assessment

Tool (SAT) to assist repository operators indetermining how well their repository follows theISBER Best Practices for Repositories. Theassessment is confidential and aimed at helpingspecimen collection centers strengthen their practicesthrough the identification of areas in need ofimprovement.

ISBER is pleased to announce that the tool is nowavailable to non-members for a fee of $180 (US).ISBER Members can continue to access the tool

for FREE as part of their member benefits!

n Available FREE to ISBER Members (non-members can access the tool for $180US)

n 158 Questions

n Sections corresponding to sections of ISBER Best Practices for Repositories

n Updated in 2012 to reflect changes in the 3rd edition of Best Practices!

n Assessment can be completed in approximately one hour...online for your convenience!

n Personalized feedback for your repository

n Participants receive a “risk-balanced assessment score” that will help you to evaluate how well your current practices conform to the ISBER Best Practices.

www.isber.org/SAT

Certified Repository Technician

Program

ISBER recognizes that a need exists for broadly

available, consistent education and trainingopportunities for repository technicians. TheCertified Repository Technician Training Programwill ensure that those who desire it can have accessto a body of knowledge that will support theirunderstanding of successful strategies forsupporting the collection, processing, storage anddissemination of high quality biospecimens forresearch. To this aim, the Society is partnering withthe Board of Certification of the American Societyfor Clinical Pathology (ASCP) to explore thefeasibility of developing what is being called aCertification Program for Repository Technicians.Successful participants in the program will becertified for their acquisition of knowledge essentialto repository operations.

Updated information will be posted onwww.isber.org as it becomes available.





Report on the ESBB Biobanking

Conference in Granada

In November 2012 the European, Middle Eastern & African Societyfor Biopreservation & Biobanking (ESBB) and the Spanish NationalBiobank Network (Red Nacional de Biobancos) held a joint annualconference in Granada, southern Spain and the venue was theGranada Conference and Exhibition Centre. The local host and co-organiser for the conference was the Andalusian Public HealthSystem Biobank (Biobanco del Sistema Sanitario Público deAndalucía).

The conference attracted a total of 523 attendees from 41 countriesand there were a total of 48 companies participating in theconference exhibition. Gold sponsors were MVE Chart, Cryo BioSystem, Hamilton and Sysmex. Silver sponsors included Tecan,ThermoFisher, Visiopharm, Perkin Elmer, Brooks Life ScienceSystems and Taylor Wharton.

The conference theme was “Biobanks: Advancing Science andServing Society in the 21st Century” and the 10 speaker sessions(4 plenary and 6 concurrent) covered a range of diverse topics.There were 33 invited speakers and 10 contributed papers in thesesessions.

The first session on future directions for biobank networks includeda keynote talk by Manuel Morente who described the Spanishperspective and emphasised the importance of buildingcollaborative environments. In the same session there were talksby Peter Riegman (EurocanPlatform), Peter Watson (CanadianTumour Repository Network) and Yeonhee Lee (Asian Network ofResearch Resource Centers), which provided a very global start tothe conference.

Biobanking in emerging countries was a major focus at thisconference. This was the subject of two sessions for whichspeakers included Muntasser Ibrahim, Rupert Langer, Patrick

Sluss, Pasquale De Blasio, Maher Sughayer, Khalid Siddiqui,

Michael Igbe, and Bongiosi Dumas. Thanks to the generosity of5 corporate sponsors (Biobusiness Consulting, Tissue Solutions,Taylor Wharton, Qiagen and Freezerworks) it was possible to fund

6 travel fellowships from emerging countries across the ESBBregion and this allowed awardees from Zimbabwe, Nigeria, Kenya,Uganda and the West Bank to attend the conference. A workshopon biobanking in emerging countries was organised and chaired byRita Lawlor and Erik Steinfelder. Speakers also included Rupert

Langer and Maimuna Mendy. The workshop followed the IdeasLab format and featured a series of topics to kick off interactivesubgroup discussions aimed at answering a number of keyquestions. Topics included: feasibility of biobanking; lack ofpathology; problems of infrastructure; and protecting localpatrimony. The level of enthusiasm and engagement seen at thisworkshop, made it a very memorable occasion and a promising stepforward for ESBB. As a result, an Africa Biobanking subgroup wasestablished by Rita Lawlor and communications are continuing inthe corresponding subgroup of the ESBB LinkedIn group.

There were many outstanding presentations in sessions onbiopreservation science; data protection (ELSI and technicalaspects); and biodiversity biobanking. There was also a verypopular workshop on automation chaired by Gunnel Tybring andMarcel Bruinenberg, and a session on “Defining Biobank”presented by Robert Hewitt and Peter Watson. For furtherinformation, please visit the conference website at:http://www.esbb.org/granada/. Many of the presentations from thespeaker sessions are available for download.

Over 170 abstracts were accepted for poster presentation and 20of these were singled out for attention at the poster discussionsession. Abstracts were published in the online version of theOctober issue of Biopreservation and Biobanking and are freelyavailable at http://online.liebertpub.com/toc/bio/10/5. Prizes wereawarded in 6 categories and the prize winning posters can be seenon-line.

At the Society Forum, the gavel was passed from outgoingPresident, Peter Riegman, to incoming President Rita Lawlor.Election results were announced: Manuel Morente is the newPresident-Elect and Christina Schroeder and Roger Bjugn arethe two new Councilors.

The gala dinner was held atthe Carmen de losChapiteles and forentertainment during thedinner there were liveperformances of Flamencodancing, including sometruly impressiveperformances by severalmembers of the audience!

The conference ended witha night-time guided tour ofthe famous Alhambrapalaces. The Alhambra or“red fortress” wasconstructed in the mid-14thcentury by the Berberrulers of Granada. Itcontains a number ofpalaces and courtyardswith fountains and

reflecting pools.. Many conference attendees were so impressedby the tour that they made a second visit to Alhambra the followingday.

Granada Conference & Exhibition Centre (photo by Christina Schroeder)

Flamenco dancing at the Gala dinner (photo by Ingo Kuehl)

(Continued on page 26)ESBB



Better Mousetrap – Trinean’s DropSense96/cDrop Platform for

Sample Prep QC

Problem

The spectrophotometric absorbance ratio’s A260/A230 and A260/A280 are the conventional way for purity assessment of DNA and RNAextractions. However, this method only provides a rough estimation, while being influenced by sample characteristics like pH and saltconcentrations and insensitive for certain impurities like RNA residue in DNA samples (see figure below). This is contradictory to therequired quality control needed in biorepositories and genetic labs ensuring the robustness of complex analytical processes.

Solution - Trinean’s DropSense96 droplet reader with cDrop UV/VIS spectral decomposition software

Trinean developed an innovative approach to analyze the full UV/VIS spectral shape measured to determine the actual fraction of theDNA or RNA extract present, while listing interfering impurities as an in-depth purity analysis. This state-of-the-art mathematical analysissoftware (cDrop™) uses a model-driven approach to unravel the measured spectra into the relevant molecular components that contributeto the absorption, thereby not only reporting a highly specific concentration of the DNA or RNA extract but also estimating the sampleturbidity and amount of possible interfering impurities. The cDrop software is an add-on to the Trinean DropSense96® platform for directUV-Vis spectroscopy on microliter volume samples using unique 96well microfluidic DropPlates for manual or robotic sample loading,sample conservation and micro-cuvette read-out.

Specific nucleic acid quantification

With a single click for protocol selection, the cDrop algorithms are able to discriminate similar molecules like dsDNA and RNA withinthe measured UV/VIS spectrum. Figure 1 demonstrates the power of cDrop for quantifying dsDNA extracts spiked with RNA. Purity analysis and extraction QC

Specific quantification of the DNA or RNA samples is key before storage, but also sample purity analysis is crucial as contaminantslike phenol, salts or hemoglobin present in the extraction buffers or the sample source are known to influence downstreamapplications (PCR, qPCR, Next Generation Sequencing). The cDrop software is able to detect and quantify contaminants givingyou the opportunity to detect impure sample prior to costly and time consuming experiments. Data in Figure 1 illustrates theaccuracy of the cDrop approach for contamination detection.

The cDrop™ software enables accurate quantification of all types of biomolecule samples combined with thorough purity analysis. Overall,the Trinean DropSense96 platform combines the simplicity of micro-volume UV/Vis spectroscopy with the specificity of fluorescentquantification assays. This innovative approach is a breakthrough technology in DNA/RNA or protein sample preparation and QC.

For more information contact Tony Montoye, Email: [email protected] or visit our website www.trinean.com



International Society for Biological

and Environmental Repositories

9650 Rockville Pike, Suite E133Bethesda, MD 20814-3993 (USA)

A Division of ASIP, a Constituent Society of FASEB

ESBB(Continued from page 23)

The above photo of an Alhambra palace courtyard by Ingo Kuehl,won 1st prize in our photo competition. The other entries can beseen at: http://www.esbb.org/granada/

The post-conference survey was helpful in identifying specific areasfor improvement and in general the feedback was very positivewhich is encouraging for all concerned. The next ESBB conferencewill be in Verona, Italy from the 9th – 11th October 2013 and this willbe held in collaboration with BBMRI-Italy. Hope to see you there!

Robert HewittESBB Executive Officer

Alhambra palace courtyard (photo by Ingo Kuehl)

Exhibit Space

Still Available!

There’s still space available to

exhibit at the ISBER 2013

Annual Meeting in Sydney,

Australia! ISBER Members

receive a discount on exhibit

space rental fees. Plan now

to join us at the premier event

in Biobanking!

For complete details visit:

www.isber.org/2013


Documents

Message From the President · species not normally associated with man, in human habitation encroaching upon animal environment. This can be suburban development building into woodland