Cambridge Healthtech Institute’s Third Annual

Process change For Protein scale-UP

FINAL AgeNdA

healthtech.com/BccCambridge Healthtech Institute • 250 First Avenue, Suite 300 • Needham, Massachusetts 02494 • Telephone: 781-972-5400 • toll-free in the U.S. 888-999-6288 • Fax: 781-972-5425

BIOPHARMACEUTICAL aPril 13-15, 2010 HILTON SAN DIEGO RESORT • SAN DIEGO, CA

change controlPart of:

register By march 19 and save Up to $200

KeYnote PresentationcgmP manufacturing – Validation 101: a PrimerKim Wong, Ph.D., Director, Facilities & cGMP Support, Process Development, sanofi pasteur

FeatUreD Presentationsthe role of the Pilot Plant in Product DevelopmentDavid Clark, Ph.D., Global Head of Pharma Pilot Plants, Centocor / J&J

Development, scale-Up and implementation of an advanced Downstream Process for recombinant Plasma ProteinsJens H. Vogel, Ph.D., Global CMC Development Team Leader, Head, Isolation & Purification Department, Global Biological Development, Bayer Healthcare

Determine the critical Quality attributes of Your Design space Michael Weiser, Ph.D., Project Manager, Technology Transfer, Octapharma Pharmazeutika

Quality by Design april 12, 2010Pre-conFerence short coUrse:

APRIL 13-14 | HILTON SAN DIEGO RESORT | SAN DIEGO, CA

• Master Change in Bioprocesses

• Learn Strategies and Insights from leaders in the Field

• Cut Time and Costs While ensuring safety

essential inFormation For achieVing scale!

LEAD SPONSORING PUBLICATIONS SPONSORING PUBLICATIONSCORPORATE SPONSOR wEB PARTNERS

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tUesDaY aPril 13, 2010

7:30 Registration & Morning Coffee

VALIdATION & COMPARABILITY

8:30 Chairperson’s Remarks

Boro Dropulic, Ph.D., President & CSO, Lentigen Corp.

KeYnote Presentation

8:35 cGMP Manufacturing – Validation 101: A Primer

Kim Wong, Ph.D., Director, Facilities & cGMP Support, Process Development, sanofi pasteur

Validation is a key support pillar of current Good Manufacturing Practices. It contributes to the assurance that biopharmaceutical

products are produced in a consistent and reproducible manner that provides the safety and critical quality attributes desired. Similar to all drug development activities, validation is performed as a balance between apparent competing forces including regulatory compliance, speed to market and limitation of resources. Incorporation of initiatives such as risk management and QbD also add to the changing landscape. The basics of validation and how to perform validation within this dynamic and evolving environment will be discussed.

9:05 Development of Smarter Tools: Faster Analytics for Biotherapeutics

Nathan A. Lacher, Ph.D., Principal Scientist, Pfizer, Inc.

To meet the changing product development requirements and to support a developing pipeline with increasing complexity, various strategies have been implemented to reduce the resource requirements. One strategy includes reducing the sample preparation and analysis time by utilizing enhanced analysis methodology. Another approach was to implement a phase appropriate strategy for the verification, qualification, and validation of analytical technology. In this presentation, the enhanced analytical methodology as well as components of the phase appropriate strategy will be discussed.

9:35 Establishing Successful Technology Transfer: Lessons Learned

Annie Van Broekhoven, Ph.D., Vice President, Biologicals, Innogenetics Biologicals

10:05 Compliance and Regulatory Issues for Scaling Up Biopharmaceuticals

Jeanne M. Novak, Ph.D., CEO, CBR International

10:30 Networking Coffee Break, Poster and Exhibit Viewing

AdJUSTINg PROCeSSeS TO ACHIeVe COMPLIANCe

11:10 Documentation Planning – Anticipating Filing INDs and BLAs

Les Johnson, Operations and CMC Consultant, Operations and CMC, Salamandra LLC

Many companies do not account for the importance of detailed planning and documentation for Scale Up, Process Changes and Technology Transfer. This leads to a mad scramble for details when assembling a submission. To alleviate the massive headaches associated with writing submission sections retroactively, there are rules to follow to document these key processes in real-time.

11:40 Darwinism in the BioPharmaceutical Industry: Process Changes as Part of the Evolution of a Process

Dagmar Meissner, Owner & Founder, BioProcess Solutions

As a biopharmaceutical process is scaled-up for clinical or commercial production, the company is often constrained by financial and regulatory requirements. Due to this circumstance along with the fact that science is continuously advancing, process changes are an inevitable reality in this industry in order to ensure the consistent production of a safe and efficacious drug, cost-effectively. This presentation will discuss from a process as well as a regulatory perspective the reasons and consequences of implementing process changes, as well as means of minimizing such changes through QbD.

12:10 Sponsored Presentation (Opportunity available, please contact Jon Stroup, jstroup@healthtech.com)

12:30 Luncheon Presentation or Lunch on Your Own (Opportunity available, please contact Jon Stroup, jstroup@healthtech.com)

IMPROVINg PROCeSSeS

2:00 Chairperson’s Remarks

FeatUreD Presentation2:05 Determine the Critical Quality Attributes of Your Design Space

Michael Weiser, Ph.D., Project Manager, Technology Transfer, Octapharma Pharmazeutika

Today there is a move from Quality by Example to Quality by Design. But how do we select and determine quality criteria? This presentation

will explain what the Critical Quality Attributes (CQA) are, and explore what impact they have on Quality by Design. This talk will outline at what stage in development CQA should be determined, and give case studies how to select CQA.

2:35 Paradigm Shift in Biopharmaceutical Manufacturing – 1985 → 2010: A Status Report

Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec

case stUDY:

3:05 Development and Implementation of a PAT Application for Monitoring Protein Refolding at Production Scale

Shelly A. Pizarro, Ph.D., Scientist, Process Research and Development, Genentech, Inc.

One of the goals of the US FDA Process Analytical Technology (PAT) initiative is to ‘actively manage process variability using a knowledge-based approach’. This case study presents the development of a continuous monitoring system for a protein refolding reaction that is highly dependent on oxygen. Laboratory scale development in 3-L bioreactors using sensors for % dissolved oxygen and redox resulted in a PAT application that provided consistency in product quality and process performance across batches. Implementation at production scale demonstrates the method robustness at multiple scales.

3:35 Sponsored Presentation sPonsoreD BY

3:55 Networking Refreshment Break, Poster and Exhibit Viewing

4:30 Analytical Methodologies to Simplify In Process Product Quality Assessment

Dell Farnan, Ph.D., Group Leader, Protein Analytical Chemistry, Genentech Inc.

Samples from in-process pools often require additional sample preparation steps before they can be evaluated using popular methods for size and charge heterogeneity. These sample steps can potentially introduce a bias to the results; therefore the suitability for use needs to be ensured. Sample to Result approaches that minimize the number of steps involved, minimizing labor and risk will be discussed.

5:00 Use of Transgenic Systems for the Production of Antibody Related Products

Julio Baez, Ph.D., Senior Science Fellow, FibroGen Inc.

Recently a transgenic animal milk-derived biopharmaceutical was approved while several transgenic plant-derived products are advancing in clinical trials. We had also seen the use of alternative production systems to mammalian cell culture to meet the cost, quality, and production demand of antibody-related products. The introduction of alternative production technologies for biopharmaceuticals is coupled with advances in analytics allowing the study of microheterogeneity associated with the production system. In this talk, we will explore how transgenic animals and plants can provide enabling technology and diverse antibody-related products with improved quality as compared with current systems while providing practically unlimited product supplies at a low cost. We will also discuss the development of the first monoclonal antibody derived for a transgenic system (corn seed).

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5:30 Small Group Break-Out Discussions

We present these one-hour moderated discussion groups to allow researchers the opportunity to network and exchange information with colleagues from around the world in a small-group setting. Each table will address a scientific topic that is related to the meeting to enhance indepth discussion and interactive problem solving with the potential for establishing collaborations. You will select a topic group, sit down at the selected table, and join the discussion.

Table 1: Incorporating Single-Use Technologies into Downstream ProcessesModerator: To be Announced

Table 2: Dealing with Regulatory Authorities & InspectionsModerator: To be Announced

Table 3: Just-In-Time Use & Sourcing Raw MaterialsModerator: To be Announced

Table 4: Developing and Maintaining Continuous Improvements Moderator: To be Announced

Table 5: The Steps to Achieve Lean Manufacturing for BiologicsModerator: To be Announced

6:30 Networking Reception in the Exhibit Hall

7:00 End of Day One of Process Change for Protein Scale-Up

WEDNESDAY, APRIL 14

8:00 Morning Coffee

PROCeSS CHANge – SCALINg UP

8:30 Chairperson’s Remarks

Dagmar Meissner, Owner & Founder, BioProcess Solutions

FeatUreD Presentation & case stUDY8:35 Development, Scale-Up and Implementation of an Advanced Downstream Process for Recombinant Plasma Proteins

Jens H. Vogel, Ph.D., Global CMC Development Team Leader, Head, Isolation & Purification Department, Global Biological Development, Bayer Healthcare

This case study will cover the development and implementation of new platform technologies and processes for more efficient manufacturing of next-generation recombinant protein drugs at Bayer. The challenges during development, scale-up and transfer will be highlighted, as well as the concepts and methodologies used to successfully overcome them. Data will be shown from small-scale through commercial scale, including a comparison with a conventional process.

9:05 Highly Efficient Production of Diverse Protein Targets From Cell Substrates Engineered With Lentiviral Vectors

Boro Dropulic, Ph.D., President & CEO, Lentigen Corporation

Lentiviral vectors are known as the most efficient method to deliver genes stably into cells. There are several significant advantages for using this technology for protein production: (i) Quality – multiple gram levels of protein production from mammalian cells while maintaining high levels of glycosylation; (ii) Flexibility – applicable to all mammalian cell types, including adherent or suspension cells; (iii) Speed – multiple gram quantities of fully glycosylated protein within 12 weeks of sequence availability; (iv) Robust productivity – high transgene copy number per cell mitigates risk of gene silencing; and (v) Economics – high level of production in supernatant significantly decreases upstream and downstream costs; this technology is well suited for integration with disposable bioreactor systems.

9:35 Manufacturing Process Changes for Biotech and Pharmaceutical Products

Suketu Desai, Ph.D., Vice President, Chemistry, Manufacturing, Controls & Quality, Ception Therapeutics, Inc.

Manufacturing changes are routinely required during manufacture of biotechnology and pharmaceutical products. An overview of study design to support scale up and process validation for manufacture of biotechnology drug substance and drug products will be presented.

9:55 Sponsored Presentation (Opportunity available, please contact Jon Stroup, jstroup@healthtech.com)

10:15 Networking Coffee Break, Poster and Exhibit Viewing

MANAgINg THe MANUFACTURINg eNVIRONMeNT

11:00 Increasing Commercial Capacity via the Integration of Process and Facility Enhancements

Erik T. Fouts, Ph.D., Senior Director, Process Sciences, BioMarin Pharmaceutical, Inc.

Several approaches can be used to meet the demands of expanding markets for commercially licensed therapeutic proteins. Capacity can be increased by constructing new manufacturing areas, increasing the scale of operations, and/or introducing new cell lines or technologies that can provide greater productivity. Often, several options are simultaneously evaluated in the development of a strategy that addresses both the business risk and regulatory path. This presentation will review the options described above as they were assessed and applied to the lifecycle management of a commercially licensed recombinant therapeutic enzyme.

FeatUreD Presentation11:30 The Role of the Pilot Plant in Product Development

David Clark, Ph.D., Global Head of Pharma Pilot Plants, Centocor / J&J

The R&D pilot plant plays a critical role in scale up and process development. This presentation will take a holistic view and illustrate how the pilot plant can be most effectively used to enhance product

development, process technology development, technology transfer, and personnel development.

12:00 End of Process Change for Protein Scale-up

co-locateD at same time anD Place as:

Post-translational moDiFications | APRIL 13-14

healthtech.com/ptm

AND BACk-TO-BACk WITH

comParaBilitY at all stages oF DeVeloPment | APRIL 14-15, 2010

healthtech.com/cmb

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PRE-CONFERENCE SHORT COURSE*MONDAY, APRIL 12

1:30pm – 5:00 QUALITY BY DESIGN

12:30pm Registration

1:30 Chairperson’s Remarks

1:35 Quality by Design and its Practical Application

Ron Taticek, Ph.D., Director, Pharma Technical Regulatory, Genentech, Inc.

2:35 Critical Quality Attributes for Biologics – What Are They and How Do We Measure Them?

Tina S. Morris, Ph.D., Vice President, Biologics and Biotechnology, United States Pharmacopeial Convention

3:05 Refreshment Break

3:30 Determining Critical Quality Attributes for Biopharmaceutical Glycosylation

Daryl Fernandes, Ph.D., Chief Executive Officer, Ludger Ltd.

4:00 Regulatory Perspectives on QbD for Biotechnology Products

Michele K. Dougherty, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, OBP/OPS/CDER/FDA

4:30 Discussion

5:00 End of Quality by Design Short Course

*Separate registration is required for short courses

ReAd wHAT THe exPeRTS HAVe TO SAY ABOUT THIS eVeNT:

‘an excellent program with a nice balance of talks on relevant and

important issues.’ Daryl Fernandes, D.Phil., Chief Executive

Officer, Ludger Ltd.

“a scientifically rigorous program.”

Heidi Zhang, Ph.D., Fellow, Head of Mass

Spectrometry PSP-ARD, Novartis Biologics

“this looks a great conference.” Alistair Kippen Ph.D., Associate Director,

Analytical Biochemistry, MedImmune Ltd

10 COMPELLING REASONS fOR SPENDING 31/2 DAyS OUT Of THE OffICE: 1. 54 Industry and Regulatory presentations

2. Choice of 16+ break-out discussions in small groups for in-depth debate on challenging areas

3. Four US and EU Regulatory Presentations: CDER/FDA and Paul Ehrlich Institute

4. Analytical technologies from Genentech, Novartis, Pfizer, MedImmune, Roche, Abbott, Human Genome Sciences, Sandoz, Five Prime Therapeutics, Ludger, Merck and Peptimmune

5. Learn about Genentech’s new expanded Comparability Protocol using Quality by Design concepts, and Quality Risk Management

6. Gain expertise on managing processes from Pfizer, sanofi and Genentech

7. Bioassays from Pfizer, Novartis, MedImmune and Biomarin

8. Additional case studies from Biogen Idec, UCB-Group, UCB-Celltech, Bayer Healthcare, Innogenetics, and Facet Biotech

9. Master the unknowns relating to scale-up from Bayer, BioMarin and Centocor/J&J

10. Network with hundreds of colleagues from around the world.

BIOPHARMACEUTICAL change controlProcess Change for Protein Scale Up • Post-Translational Modifications • Comparability

Process change For Protein scale UP is part of a three-track event:

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sPonsorshiP oPPortUnities inclUDe:Sponsored Presentation

Present your scientific research and solutions for 15 or 30 minutes as part of the conference program, ensuring your audience is seated and ready to listen.

Luncheon Workshops

Invite session delegates to enjoy lunch on your company’s behalf while you give a 30-minute presentation. Your workshop is concluded with 15 minutes of Q&A, allowing you to interact with your customer base.

Invitation Only Networking Receptions

CHI will invite all delegates from a specific conference program to a private reception at the host hotel. Cocktails and hors d’œuvres will be served in a setting conducive to networking. These receptions are available on a first-come, first served basis. Presentation opportunities are limited, so reserve your talk today to ensure participation!

Exhibitor Information

The exhibit hall presents an excellent opportunity to network with prominent scientists and executives who attend the event to learn about cutting-edge research and technologies in their field. Exhibiting will allow your company to meet hard-to-reach prospects face to face, and pave the way for future sales. Exhibit space fills up quickly, reserve your space today!

Other Promotional OpportunitiesConference Tote Bags•Badge Lanyards•Corporate Branding Packages•Tote Bag Inserts•Refreshment Breaks •And more!•

We can customize any opportunity to meet your current marketing objectives and budget. To find out more about our comprehensive sponsorship and exhibit packages, please contact:

Jon Stroup, Manager, Business Development 781-972-5483 | jstroup@healthtech.com

hotel & traVel inFormation:Hilton San Diego Resort 1775 East Mission Bay DriveSan Diego, CA 92109Ph: 619-276-4010Fax: 619-275-8944www.Hilton.com/SanDiegoResort

Discounted Room Rate: $169 s/d

Discounted Room Rate Cut-off Date: March 12, 2010

Please visit our website to make your reservations online or call the hotel directly to reserve your sleeping accommodations. Identify yourself as a Cambridge Healthtech Institute conference attendee to receive the reduced room rate. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early.

Flight Discounts:

To receive a 5% or greater discount on all American Airline flights please use one of the following methods:

Call 1-800-433-1790 (authorization code 4640AF)•

Go online at • www.aa.com (enter 4640AF in promotion discount box)

Contact Wendy Levine, Great International Travel: 1-800-336-5248 ext. 137•

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Special discount rentals have been established with AVIS for this conference. Please use one of the following methods:

Call AVIS, 800-331-1600 use our Avis Worldwide Discount •(AWD) Number J868190

Go to www.avis.com use our Avis Worldwide Discount •

(AWD) Number J868190

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Mail Registration to: Cambridge Healthtech Institute

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BIOPHARMACEUTICAL aPril 13-15, 2010 HILTON SAN DIEGO RESORT • SAN DIEGO, CA

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