Innovative Biopharmaceutical Manufacturing Solutions for Multi-Product Pipelines, Global Markets, On-Demand Scale-up/Scale-down and Capacity Optimization

IBC Life Sciences 2nd Annual

FlexibleFacilities

Premier Publication: Silver Sponsors:

February 24-25, 2014 The Claremont Hotel Club & Spa Berkeley, CA

Share New Ideas in 2 Interactive Discussions

• Novel Facility Design Concepts

• Flexible Vaccine Facilities

• Single-use vs. Stainless Steel: Pros and Cons

• Functionally-Closed Processing in CNC Environments: What is Holding Us Back?

• Where Do You Have to Compromise When Designing and Implementing a Flexible Facility?

Abdullah Baaj, M.D., PharmD. CEO, Boston Oncology

Adam Goldstein Principal Scientist, Global Manufacturing Sciences, Genentech, Inc.

Wallace Lauzon, Ph.D. Acting Chief, Cytokines Division, CERB, BGTD, Health Canada

Alex Tschumakow Director, Manufacturing, Shire HGT

EMERGING MARKETS & BIOSIMILARS

RISKS OF SINGLE-USE

REGULATORY PERSPECTIVES

FACILITY CASE STUDY

Biopharmaceutical Pipelines and Facility Needs are Changing ... Are You Prepared?

Organized by:

• Clinical and Commercial Implementation

• Facilities for Emerging Markets

• Lessons from the U.S. Government: BARDA and DOD

“Gave me the pulse of the industry on this topic.”

Marc Devlaminck, Associate Director, Merck & Company

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Bronze Sponsors:

www.IBCLifeSciences.com/Facilities

Register Today for a Look at State-of-the-Art Facilities, Technologies and Processes to Optimize Your Future Production Needs

IBC’s 2nd Annual Flexible Facilities conference brings together senior level executives and scientists from biopharmas, CMO’s, technology providers, engineering firms and regulatory groups to explore the changing landscape of biologics manufacturing and to share case studies of the latest flexible facility implementations, lessons learned and practical experiences.

Attend this ground-breaking event to learn about current and future state-of-the-art innovations in flexible technology, facility design and process design. You will learn about the technical, business, regulatory and economic considerations, as well as the opportunities and challenges of creating flexible production facilities for your organization.

LEARN about Novel Facility Design Conceptsâ �100% disposable and hybrid facilities

â �Retrofitting stainless steel to be more flexible

â �Modular systems and plug & play designs

â �Multi-product facilities, open ballrooms and closed systems

PREPARE Yourself for Rapid Deployment and Emerging Market Opportunitiesâ �Biosimilars, flexible systems and emerging markets

â ��Establishing manufacturing capacity in BRIC regions

â �Production strategies for pandemics and biothreats

HEAR about Practical Experiences in Single-use Implementationâ �Single-use in vaccine upstream processes

â �Case study comparing a single use mAb process to a stainless steel process

â �Functionally-closed systems and multi-product facilities

DISCOVER How BARDA and the DOD are Developing Flexible Facilitiesâ �Emergent’s flexible manufacturing capabilities and facilities

â �Novartis Vaccines and the Holly Springs manufacturing site

â �Kalon Therapeutics and Texas A&M University’s Collaboration

â �Nanotherapeutics flexible manufacturing for Medical Countermeasures

“.. a timely meeting that addressed the benefits and challenges of flexible facilities and single use bioreactors and the necessity to

prepare ourselves for the future.”Tony D’Amore, Vice President, Bioprocess Research &

Development North America, Sanofi Pasteur

“Great dialogue on how “adaptable” and flexible designs and facilities are likely to be in the future.”

Kevin Lear, Senior Process Engineer, NNE Pharmaplan

“Very worthwhile conference providing excellent information on different facility design options.”

Maik Jornitz, Vice President, G-Con LLC

“Thank you for a great conference. I thought it was fantastic.”Andy Walker, Ph.D., Vice President,

Process Development, CMC Biologics

Kalon/TAMU

G-CON

KEYPLANTS

2 This event sold out in 2013 – be sure to register early to save your spot: www.IBCLifeSciences.com/Facilities

7:30 Registration and Coffee

8:15 Chairman’s Welcome and Opening Remarks

The Changing Landscape of Biomanufacturing Facilities

Featured Presentations 8:20 Critical Aspects and Risks in Implementing

Single Use Technologies in Flexible Facilities Single use technologies offer a number of advantages in terms of increased flexibility, however, there are some important issues one must consider. This presentation highlights the areas of benefit and gain when implementing disposables, as well as the potential risks and challenges.Adam Goldstein, Principal Scientist, Global Manufacturing Sciences, Genentech, Inc.

9:00 Regulatory Perspectives on Flexible Facilities The introduction of disposable equipment into the manufacturing process for biological drugs has been taking place gradually over the last several years. This has been accelerating recently with the introduction and uptake of more robust disposable manufacturing solutions. The existing regulatory framework for biologics can accommodate these changes though challenges exist in the application particularly where flexibility is maximized. An overview of the regulatory perspective on flexible facilities will be discussed. Wallace Lauzon, Ph.D., Acting Chief, Cytokines Division, CERB, BGTD, Health Canada

9:40 Networking Refreshment Break and Exhibit/Poster Viewing

Rapid Deployment and Facilities for Emerging Markets

Featured Presentation 10:10 Flexible Facilities Democratization of Biosimilars'

Opportunity in Emerging Markets This presentation will take the perspective of an executive examining the biomanufacturing options for production of biosimilars in emerging markets. In this investigation, we will explore the levers and inflexion points that drive such decisions and facilitate an objective decision-tree analysis to choose facility type. Since 2007 Boston Oncology has operated in developing countries and emerging markets (EM). Now The Company aims to localize production capabilities in 4 contents, conduct transcontinental clinical trials, utilize regulatory bodies in EM as primary reviewers in an emerging-markets-centric strategy. Relying on the experience of Boston Oncology, we will conclude with identifying factors for successful entry with lessons learned from effective strategies and major mistakes.Abdullah Baaj, M.D., PharmD, CEO, Boston Oncology

10:50 Case Study Reinventing Biomanufacturing: Case Studies of Flexible Facilities; Multi-product Vaccine Facility – Benefits and ChallengesCase study 1: Real success criteria for flexible facilities: From ground breaking to 20 GMP batches in 18 months. The facility is not the end point, the first batch is. Organizational capabilities crucial for realization of single use technology facility value. Technology transfer capability as a critical business process for flexible manufacturing facilities. Case study 2: Multi-product Vaccine facility – benefits and challenges. How to secure sufficient segregation to minimize the risk of cross contamination. High level flexibility based on standardization of layout principles. Logistic issues by running multi-product facilities. Niels Guldager, Senior Technology Partner, NNE Pharmaplan, DenmarkKlaus Hermansen, Senior Technology Partner, NNE Pharmaplan, Denmark

Monday, February 24, 2014

Register Today for a Look at State-of-the-Art Facilities, Technologies and Processes to Optimize Your Future Production Needs

Flexible Facility Design Strategies and Practical Implementation Experiences

11:30 Case Study Facility of the Future – Single Use Facility, A Case Study from Biogen IdecIn 2012, Biogen Idec completed its first single use disposable manufacturing facility named FVM (Flexible Volume Manufacturing). This new manufacturing facility incorporated many innovative designs and seamlessly integrates operations into its existing facility in RTP (Research Triangle Park). This case study will highlight some of the design feature and intent, compare the cost of construction of this facility vs. comparable traditional stainless steel facility, and finally some lessons learned from its first campaign. Chien Lin, Senior Manager, Process Engineering, Global Project Engineering, Biogen Idec, Inc.

12:00 Flexible Facilities: Too Much Too Soon?Flexible facilities have been promoted as a cost-effective solution for smaller companies and startups. With the adoption of single-use pilot plants by global pharmaceuticals, the concept of flexible facilities is changing and becoming more sophisticated. An analysis will be presented about typical deployments of single-use facilities, and why in many cases “small and simple” is more than enough when planning a single-use strategy.Barbara Paldus, Ph.D., Chief Executive Officer, Finesse Solutions

12:30 Networking Luncheon followed by Exhibit/Poster Viewing and Dessert

1:45 Development Pilot Plant Design and Considerations for Vaccine and Cell Therapy ProjectsGiven that possessing the capabilities and capacity to simultaneously develop processes of varying nature and scales within an R&D facility is a challenging task, this presentation will focus on the past history, present operations, and future efforts to allow multiple projects to co-exist in Janssen R&D’s Large Scale Development Lab.Paul Ko, Ph.D., Senior Scientist, Janssen Research & Development

2:15 Creating Flexibility in Biomanufacturing FacilitiesAbstract not available at time of print. Please visit www.IBCLifeSciences.com/Facilities for updates.Thermo End-User Speaker TBA

2:45 Flexible Supply Chain – A Complement to Flexible Facility OperationsWith changes in technology and industry practices moving toward flexible facility design and operations, it is imperative that flexibility is built into the supply chain. A flexible supply chain can mitigate the risk of bottlenecks from stock out or excessive carrying costs in the rapidly changing environment created by a truly flexible facility. With all of the potential that flexible facility design enables, having a flexible supply chain can support pushing the operational capability of a plant instead of hindering it.Eric Hanson, Senior Manager, Facilities & Operations, Gilead Sciences, Inc.

3:15 Networking Refreshment Break and Exhibit/Poster Viewing

“The conference provided a balanced view of the current

state-of-the-art technologies available to support flexible manufacturing options.

The discussions around regulatory requirements and expectations

were invaluable.”Jose A. Caraballo, Director Global QA,

Bayer HealthCare

For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/Facilities 3 2 This event sold out in 2013 – be sure to register early to save your spot: www.IBCLifeSciences.com/Facilities

Monday, February 24, 2014 (continued)

Flexible Facilities and Closed Systems

3:45 Case Study Implementing New Flexible and Single-Use Devices and Processes for Vaccine Manufacturing: Case Study on Formulation and FillingThis presentation will cover two case studies as they relate to biopharmaceutical manufacturing. The first discusses formulating a multi-component vaccine product in closed system, single-use manifolds: technical considerations for filtration, mixing, sampling and fluid transfer. The second will review experiences designing and testing novel pre-sterile, single-use filling lines. Both will cover challenges and lessons learned from planning, process design and implementation stages.Kirsten Strahlendorf, Senior Scientist, Sanofi Pasteur, Canada

4:15 New Data Evaluating the Effectiveness of Liquid Sanitizing Agents to Establish Functionally-Closed SystemsFunctionally-closed systems are frequently encountered when single-use systems are connected to stainless steel systems. The effectiveness of sanitization methods can impact the facility design and operation. Approaches for evaluating sanitization effectiveness are presented as well as how that data can potentially be leveraged to simplify facility design.Scott Probst, Ph.D., Group Head, HealthCare and Biotechnology, Bayer Technology Services, Germany

Panel Discussion 4:45 Functionally-Closed Processing in CNC Environments:

What is Holding Us Back?• What defines a closed system?• How closed is closed in a closed system process?• Regulatory perspectives in closed systemsPanelists:Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers Scott Probst, Ph.D., Group Head, HealthCare and Biotechnology, Bayer Technology Services, Germany Sebastien Ribault, Ph.D., Director, Bioproduction and Development, Merck Millipore, France

5:15 Close of Day One

7:45 Registration and Coffee 8:30 Chairman’s Remarks

R. Thomas Warf, Director, Manufacturing, Facilities & Engineering, BARDA, U.S. Department of Health & Human Services

Flexible Biomanufacturing Facilities: Lessons from the U.S. Government Centers for Innovation in Advance Development and Manufacturing 8:40 HHS Centers for Innovation in Advance Development and

Manufacturing (CIADM) FacilitiesThis presentation reviews the current and designed facilities of the Health and Human Services Centers for Innovation in Advance Development. The current facilities and the designs of future facilities will be discussed to show the support the CIADM contracts. The contractors are Emergent BioSolutions, Baltimore, MD, Novartis Vaccines, Holly Springs, NC and Texas A & M University System, College Station, TX, and they support flexible process development (phase I thru III) and manufacturing of final product. The HHS requirements and some potential HHS projects will be reviewed.R. Thomas Warf, Director, Manufacturing, Facilities & Engineering, BARDA, U.S. Department of Health & Human Services

9:00 Partnering with HHS BARDA to Establish Flexible Manufacturing Capacity to Develop Medical CountermeasuresDiscussion will include an overview of the Novartis Vaccines and the Holly Springs manufacturing site. The site is the product of a public/private partnership between HHS BARDA and Novartis Vaccines. This site is comprised of Bulk Cell Culture Influenza manufacturing, a pre-filled syringe filling facility, and a pilot plant facility. The pilot plant facility is being retrofitted to provide additional capabilities for clinical trial filling as part of an HHS contract to provide a Center of Innovation and Advanced Development and Manufacturing (CIADM) capability to develop medical countermeasures.Chris McDonald, Site Head, Holly Springs Site, Novartis Vaccines and Diagnostics

9:30 Emergent’s Flexible Manufacturing Facility In June 2012, Emergent was selected by DHHS as one of the Centers for Innovation in Advanced Development and Manufacturing (CIADM). This presentation gives an overview as to how this important public-private partnership builds on Emergent’s existing flexible manufacturing capability and further expands it for pandemic influenza surge production, as well as for advanced development of other medical countermeasures for emergencies and threats. Vijay Yabannavar, Ph.D., Senior Vice President, Manufacturing Operations and Process & Analytical Development, Emergent BioSolutions

10:00 Networking Refreshment Break and Exhibit/Poster Viewing

10:30 Case Study Flexibility Defined: A Case Study on Multi-Product, Multi-Technology Vaccine Manufacturing FacilitiesIn partnership with BARDA and the Texas A&M University System, Kalon operates the National Center for Therapeutics Manufacturing (NCTM) which employs multi-product, single use technologies and mobile clean rooms. In addition, the partnership is breaking ground on next generation, high containment facilities for pandemic influenza response and viral-based vaccines. This case study examines the NCTM operations and the design basis for the new facilities.Andrew Strong, President and CEO, Kalon Biotherapeutics

11:00 Intersection of cGMP & Biocontainment Design in Biopharmaceutical Medical Countermeasure ProductionThis presentation provides an overview of several projects funded by the Biomedical Advanced Research & Development Authority (BARDA) in which biocontainment and biosafety design elements had to be incorporated into pilot- and commercial-scale biopharmaceutical facilities. The projects will encompass both retrofitting and new construction (green field).Michael P. Angelastro, Deputy Director, Manufacturing, Facilities & Engineering, BARDA, U.S. Department of Health & Human Services

11:20 The Application of Single Use Technology for Agile, Flexible Manufacturing of Medical CountermeasuresNanotherapeutics, Inc. (Alachua, FL) has recently been awarded a government contract to provide the Department of Defense with an Advanced Development and Manufacturing (NANO-ADM) Center as a dedicated resource to rapidly develop and manufacture Medical Countermeasures (MCMs). The NANO-ADM Center will include facilities, equipment and expertise to manufacture biologic products to respond to the US Government’s national security needs for Medical Countermeasures, leveraging flexible manufacturing and modern platform technologies to provide warm-based vaccine and MCM capabilities for potential outbreaks of emerging infectious pathogens of currently known or unknown threats. The facility design will integrate flexible, modular (single use, disposable), adaptable and scalable processes and equipment in a facility that is compliant with cGMP and BSL-3 guidelines.Andrew Graham, Senior Director, Operations-Manufacturing, Nanotherapeutics, Inc.

Tuesday, February 25, 2014

“Excellent industry overview of new facility and process design

concepts including single use, HVAC and automation trends.”Chuck Reed, Associate Director,

Engineering, Biogen Idec

Group Savings: Register 3 or More and Save 20%

See page 7 for complete details

4 Register Early for Best Savings • www.IBCLifeSciences.com/Facilities • 800-390-4078

Tuesday, February 25, 2014 (continued)

Panel Discussion 11:50 Where Do You Have to Compromise When Designing and

Implementing a Flexible Facility?• What facility design criteria are most important for your product portfolio?• How to balance optimal facility needs with accelerated timelines and

limited resources?• What compromises should you never make when designing your facility?

Moderator: R. Thomas Warf, Director, Manufacturing, Facilities & Engineering, BARDA, U.S. Department of Health & Human ServicesPanelists: Chris McDonald, Site Head, Holly Springs Site, Novartis Vaccines and Diagnostics Vijay Yabannavar, Ph.D., Senior Vice President, Manufacturing Operations and Process & Analytical Development, Emergent BioSolutionsAndrew Strong, President and CEO, Kalon BiotherapeuticsAndrew Graham, Senior Director, Operations-Manufacturing, Nanotherapeutics, Inc.

12:20 Networking Luncheon followed by Exhibit/Poster Viewing and Dessert

1:25 Chairman’s RemarksThorsten Peuker, Ph.D., Vice President, Integrated Solutions, Sartorius Stedim Biotech GmbH, Germany

Implementing Single-Use and Other Technologies to Create More Flexible Facilities

1:30 Case Study Single-use Mixing Systems in Large-scale Live-viral Vaccine Upstream ProcessesThe rapid development and licensure of two live-attenuated viral vaccines produced in SP’s Canton MA facility has been accelerated by the incorporation of single-use technology. We have successfully applied Single-use Mixing Systems (SUM) at various stages of the upstream processes for cell expansion and bioreactor harvest, all under closed-system aseptic conditions. Boundary-condition experiments for solution and suspension mixing were followed by investigations to establish cell suspension homogeneity while maintaining viability. Representative sampling, mixing homogeneity, and maintenance of cell viability results will be presented.Daniel C. Vellom, Ph.D., Senior Director, Biotechnology Expert, Global Technology Innovation, Sanofi Pasteur Biologics, LLC

2:00 Case Study Increasing Control and Flexibility for Development and Manufacturing Processes A case study is presented comparing a single-use mAb process to an established stainless steel process. The quality of the molecule plus titer and cell growth is compared between the different technologies at different scales. Several clinical runs at 200L and 1250L scale were performed to ensure a meaningful comparison. Operator feedback on the ease of use and the necessary changes in the GMP area to introduce single-use technologies are also discussed. Sebastien Ribault, Ph.D., Director, Bioproduction and Development, Merck Millipore, France

2:30 Process4Success - Flexible Biomanufacturing Processes Addressing the Needs of the FutureIn order to reduce cost and shorten timelines, engineering efforts have to be reduced as much as possible. Generic process platform concepts for the overall process enable a faster execution time as well as more efficient qualification procedures. In this contribution, we focus on monoclonal antibody (mAb) processes as a major product class from the biopharmaceutical industry. A study will introduce our process platform concepts “Process4Success” integrating single-use equipment for an existing building and for a greenfield facility. In addition, innovative facility layouts using modular cleanrooms will be presented.Thorsten Peuker, Ph.D., Vice President, Integrated Solutions, Sartorius Stedim Biotech GmbH, GermanyFritjof Linz, Ph.D., Vice President, Global R&D, DSM Biologics

3:00 Networking Refreshment Break and Exhibit/Poster Viewing

Featured Presentation 3:30 Case Study Single Use Systems –

An End User’s Perspective Shire, faced with the need to increase manufacturing capacity in a flexible way to meet growing demand for its commercial and clinical products, responded with construction of a state-of-the-art plant that maximized deployment of Single Use Systems (2011 ISPE Facility of the Year Honorable Mention). This talk will review the business case, the challenges associated with design and start-up, regulatory acceptance / approval, routine use of Single Use Systems, and some lessons learned along the way.Alex Tschumakow, Director, Manufacturing, Shire

4:00 "The Dinosaurs Reborn": Optimally Retrofitting Facilities for FlexibilityOne of the critical considerations for Biomanufacturers today, is how to make best use of their current facilities ('dinosaurs') in an environment that is becoming increasingly modular and single-use based. While existing facilities can be retrofitted at a fraction of the cost and downtime of building a new facility, analyzing the impact of new technologies is more difficult than for a 'greenfields' facility. In this talk, we examine data collected by Bio-G that show which areas have proven optimal for maximizing the flexibility of facility retrofits. We discuss a set of simple rules that can be used to understand where new technologies like disposables can be robustly applied. Several case studies will be presented.Rick Johnston, Ph.D., Principal, BIO-G

4:30 The Flexible Factory is Not Just a Room Full of Bags!Although “flexible” is defined as “capable of bending easily without breaking” it also means: “able to be easily modified to respond to altered conditions” or “able to adapt to different circumstances”. Biopharmaceutical manufacturers are riding the “wave of plastic” in an attempt to improve productivity, lower overall cost of goods and to lower the risk of their bioprocess operations. This presentation will compare facility design strategies in an attempt to understand where real manufacturing efficiencies can be gained.Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers

5:00 Case Study Implementing and Improving Disposable Systems in BioMarin’s Manufacturing Environment to Meet Growing CapacityAbstract not available at time of print. Please visit www.IBCLifeSciences.com/Facilities for updates.Chris M. Brodeur, Associate Director, Commercial Operations, BioMarin

5:30 Close of Conference

Take an Active Role in the Conference and Present a PosterAny registered conference attendee may register to present a poster. The deadline to submit an abstract online is January 27, 2014 to have the abstract be included in the conference materials. Full payment of conference registration and poster fees must be received by this date for the abstract to be included in the conference materials and a poster board assignment to be made (see the registration page for details on the poster fee). Posters should be PORTRAIT orientation, with maximum dimensions of 36 inches wide (3 feet) x 48 inches high (4 feet). Please note: Poster presentations may not be used as exhibit displays or for marketing purposes, and all posters are subject to approval by conference organizers. Only one poster presentation is allowed per registered attendee/author.

For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/Facilities 5

Meet the People Behind the Products and Get the Answers You Need

Make Your Company Known to this Audience!If you are a biopharma CMO, engineering firm or technology provider involved in contract manufacturing, facility design, single-use/disposables, modular systems, plug and play technologies, facility automation and related technologies you can not afford to miss this event. By sponsoring or exhibiting, you will meet thought-leaders and executives including VP’s, directors and managers who make facility-related technology and outsourcing decisions.

IBC Life Science events provide numerous sponsorship and exhibiting options that maximize your opportunity to network with industry leaders. At IBC’s Flexible Facilities, there are many ways to position your company as a leader in the industry by securing:

• High Visibility Speaking Sponsorships

• Networking Receptions and Luncheons

• Promotional and Branding Programs

• Prime Exhibit Space

Contact us today to reserve your sponsorship or exhibit booth and learn about other opportunities to promote your product or service at this event.

For more information, please contact: Sherry Johnson at sjohnson@ibcusa.com or 508-614-1451

Silver Sponsors EMD Millipore is the Life Science division of Merck KGaA of Germany and offers products used by pharmaceutical and biotechnology companies to develop and manufacture biopharmaceutical drugs safely and

efficiently. We provide fully integrated solutions to customers and an attractive range of development and regulatory services to biopharmaceutical manufacturers.

California-based Finesse Solutions, Inc., has established a proven record in providing turnkey, scalable solutions for single-use bioprocessing. The Finesse product platform includes an extensive

portfolio of novel disposable sensors, modular configure-to-order automation hardware, and intelligent software that can harmonize global bioprocess information and technology transfer. For more information, please visit us at www.finesse.com.

Sartorius Stedim Biotech is a leading provider of cutting-edge equipment

and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of "turning science into solutions." Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,000 people, and in 2012 earned sales revenue of 544 million euros. www.sartorius.com

Bronze Sponsors NNE Pharmaplan is the world’s leading engineering and consulting company in the

complex field of pharma and biotech. Engineering for a healthier world – our role in an industry that improves people’s lives worldwide.

A proven solutions provider for biopharma customers since 1967, we provide customized solutions that help clients transition from drug discovery, to clinical scale-up, through large-scale

commercial production. Our current portfolio includes the highest quality media, sera, single-use technologies, buffers and process liquids. We are known for many firsts, including the first-to-market bioprocess container, stirred-tank single-use bioreactor (SUB), 10,000L single-use manufacturing facility and other innovative technologies. www.thermoscientific.com/bioprocessing

Bio-G provides software specifically for the biopharmaceutical community that is now used in more than 20% of manufacturing facilities globally.

Our Real Time Modeling System, Crosswalk, and BioFit software applications link with your existing enterprise systems to provide rapid and highly accurate analysis to capacity engineering, debottlenecking, scheduling, and optimization projects. Visit www.bio-g.com

Supporting Sponsor Lanyard Sponsor

Confirmed Exhibitors (as of October 16, 2013)

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Ways to Save on Your Conference Registration

Register Early:

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Groups save 20% off the current rate. The earlier your group registers, the more you save. This offer is for groups of 3 or more. Contact our group sales representative at 646-895-7445 for complete details.

Academic and Government Special Rates

Full-time employees of a government organization, universities and university-affiliated hospitals are eligible to take advantage of over a 40% savings off industry rates.

Your Colleague Is Speaking at this Conference

If you are from a company that is already sending another person to present at this conference, you qualify for a 20% discount off the standard rate. Contact your colleague who is speaking for their discount code.

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If you are from a company that is exhibiting or sponsoring this event, you qualify for a 20% discount off the standard rate. Contact your marketing person for the discount code.

Venue and AccommodationsThe Claremont Hotel Club & Spa 41 Tunnel Road, Berkeley, CA 94705510-843-3000 • http://www.claremontresort.com/

Please call the hotel directly at the numbers above before January 21, 2014 or until sold out to be included in IBC's dedicated room block for this conference. Please identify yourself as a participant in IBC’s Flexible Facilities conference to receive the reduced room rate. Be sure to make your reservations as soon as possible as rooms tend to fill up very quickly and all reservations are subject to availability. The hotel will require a first night’s non-refundable deposit at the time the reservation is made.

Registration Substitutions/Cancellations: Contact IBC’s customer service team via email at reg@ibcusa.com. A written cancellations must be received by IBC prior to 10 business days before the start of the event. Upon receipt of a timely cancellation notice, IBC will issue a credit voucher for the full amount of your payment, which may be applied towards registration fees at any future IBC event held within 6 months after issuance.In lieu of issuance of a credit voucher, at your request, IBC will issue a refund less a $595 processing fee per registration. Substitutions are welcome at any time. If for any reason IBC decides to cancel this conference, IBC accepts no responsibility for covering airfare, hotel or other costs incurred by registrants, including attendees,sponsors, speakers and guests. SPECIAL NEEDS: If you have a disability or special dietary needs, please let us know in order that we may address your special needs for your attendance at this show. Please send your special needs via email to custserv@ibcusa.com

Additional Registration InformationFor onsite registrations, please add $100. Program content and speakers subject to change. Conference badges are non-transferable and lost badges will not be replaced without payment of the full conference registration fee.

Industry Fees On or before November 15, 2013

On or before December 6, 2013

On or before January 17, 2014

On or before February 7, 2014

Standard Rate After February 7, 2014

Pharma/Biotech Rate $1,899 $2,099 $2,299 $2,399 $2,499

Group Rate: Pharma/Biotech - Must Register 3 $1,519 per person

$1,679 per person

$1,839 per person

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$1,999 per person

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Group Rate: Vendor/Technology Provider/Consultant - Must Register 3 $1,999 per person

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** Academic/Government rates are extended to full-time employees of government, universities and university-affiliated hospitals only.

Present a Poster to Enhance Your Conference Experience. All poster presenters must be registered conference attendees. The fee to present a poster in addition to your conference registration is: Vendors/Supplier: $300 Pharma/Biotech: $100 Academic/Government: FREEVendor rate is for exhibiting/sponsoring companies and/or posters that upon review are of commercial/product focus

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IBC Life Sciences 2nd Annual

FlexibleFacilities

Prepare Your Facilities and Bioprocesses for a Changing Market

• Rapid Deployment/Emerging Regions

• More Complex & Diverse Molecules

• Facility Designs to Save Time and $$

• Make Stainless Steel More Flexible

• Implementation of Single-Use

• Mobile and Modular Concepts

• Multi-product/Multi-use Facilities

• Regulatory Views & Technology Gaps

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February24-25,2014•TheClaremontHotelClub&Spa•Berkeley,CA

Innovative Biopharmaceutical Manufacturing Solutions for Multi-Product Pipelines, Global Markets, On-Demand Scale-up/Scale-down and Capacity Optimization

• Discover exciting new concepts in facility design and deployment so you can rapidly scale-up/scale-down while saving time and money

• Evaluate technical, regulatory and economic perspectives so you can make the right facility choice for your products

• Learn how to design a multi-product facility with closed systems to maximize output and reduce cross-contamination risk

• Hear practical implementation stories of single-use in facilities so you can capitalize on the opportunities and avoid the pitfalls

“A good balance of executive level considerations and in-the-field technical details to inform those in the biopharm industry that operate multiproduct facilities

or design flexible production spaces.”Mike Angelastro, Project Officer, US Department of Health and Human Services, BARDA

8CaseStudiesofFacilityImplementation&LessonsLearned

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