蛋白质程序管理会议 - Day 2

短期研讨会 | Day 1 | Day 2

议程 (PDF : English)

Friday, January 11

7:30am - 4:00pm Registration 

7:30 - 8:15 Breakfast Workshop

8:15 Chairperson乫s Remarks

8:20 Increased Process Knowledge, Efficiency, and Control in Bioprocesses with On-line Liquid Chromatography
Rick E. Cooley, Manager, Process Analytics Center of Excellence, Dionex Corporation, Eli Lilly and Company (retired)
Biotech manufacturing processes can be quite challenging for those wanting to utilize PAT tools to monitor their processes due to the complexity of the typical biotech process stream. Liquid chromatography乫s attributes of high resolution and excellent sensitivity are well suited to reliably quantitate specific components in these highly challenging applications. This presentation will provide examples of how on-line liquid chromatographic based analyzers have been utilized in the biopharmaceutical industry to provide timely information for process monitoring, automation, and/or control purposes. 

8:50 The Product is the Process - Well Perhaps Not!
Mark A. Carver, Ph.D., Chief Scientific Officer, Avecia Biotechnology
Through-life process development, or quality by design, integrated with new advances in process science, manufacturing and analytical technologies should lead to much greater understanding of the characteristics of the product during scale-up. Predictable manufacturing will lead to greater flexibility in the site of manufacture as the process and the product become increasingly decoupled.

9:20 Pearls of Wisdom in Process Management
Eric Morfin, PMP PMI Pharmaceutical SIG and LIG, PMI New Product Development SIG Chair, Senior Group Director, Global Project Management, Biotech Unit, Quintiles
Process Management Leadership is getting people to do what needs to be done because they want to. Achieving this level of leadership requires that you possess critical thinking skills as well as charisma. Leaders in many industries have had to demonstrate and refine these skills for many years. We will specifically discuss the following four 乬Pearls of Wisdom乭: 

• The Art of Making Strategic Decisions 
• Motivating others with the establishment of a Human Performance Process 
• What Leadership Style should you use to Maximize your Team乫s Involvement 
• Solving Problems at the Speed of Light
• These four 乬Pearls of Wisdom乭 will be illustrated with concrete examples

9:50 Coffee Break in the Exhibit Hall

10:45 Poster Awards in Exhibit Hall

11:00 Decreasing Process Development Times and Increasing Process Understanding -- Application of Advanced Chemometrics
Bo Kara, Director, Science and Technology, Biologics, Avecia Biologics Ltd.
The focus is moving to the importance of gaining a thorough understanding
of biologics drug substance, drug product and the underlying rationale and
design of the manufacturing processes. Key to the latter is that the
design transferred to manufacturing should be demonstrably fit for its
intended use. The availability, quality and validity of process
development data from early process definition through to formal process
characterisation studies and ultimately from commercial production will
thus be crucial. This presentation looks at how various advanced chemometric methods have been successfully exploited to aid process development and increase process understanding.

Interactive Panel Discussion

11:30 How Intellectual Property Issues Affect Process Management Kristie Prinz, J.D., Founder, The Prinz Law Office John Iwanicki, J.D., Senior Partner, Banner & Witcoff Ltd. Anne Schneiderman, J.D., Ph.D., Patent Attorney, Law Offices of  Anne M. Schneiderman Jonathan Loeb, J.D., Ph.D., Partner, Day Casebeer Madrid & Batchelder LLP

12:30pm Luncheon Workshop or Lunch on Your Own

Joint Plenary Keynote Session  LYOPHILIZATION PROTEIN PRODUCTION PROCESS MANAGEMENT

1:45 Chairperson乫s Remarks 1:50 Policy, Regulatory and Engineering Considerations when Transitioning from Lab to Manufacturing Scale 2:20 Vaccines vs. Biologics: Protein Production, Process Management and Lyophilization Considerations Susan Behrens, Ph.D., Senior Director, Biological Sciences & Strategy, Merck & Co., Inc. Vaccine production shares many process features with biologics manufacturing. Common unit operations include fermentation, cell culture, chromatography, filtration, formulation, vial & syringe filling and lyophilization. As the demand for vaccine products is projected to increase by 2X over the next 5 years, the ability to transfer knowledge gained from large scale protein production provides an opportunity to maximize efficiency of production for both product areas. Synergies between biologics and vaccine manufacture Vaccines vs. biologics: Distinctive qualities and impact on production, process management and lyophilization Key supply chain issues for both vaccines and biologic products and how the two interact Leveraging lessons from biologics production as the vaccine business grows globally

3:00 Refreshment Break

Joint Interactive Workshop DEVELOPING A STREAMLINED MATRIX APPROACH FOR QUALIFICATION AND VALIDATION

MEET  ADDRESS ISSUES  TRANSFER KNOWLEDGE REACH OUT TO PEERS INTRODUCE YOURSELF  XCHANGE IDEAS 3:20 Interactive Case Studies for Matrix Validation Approaches Robert Darius, Director, Global Quality Assurance, GlaxoSmithKline Biologicals The goal of the program is to address the challenge of whether more data be provided while using less active pharmaceutical product.Whether your product is lyophilized or not, budgetary, timing, validation and regulatory concerns all coalesce during the rapid development and fast track approval processes for pharmaceutical development, scale-up and new CMO approval for pharmaceutical products. These challenges have become increasingly complex in the highly competitive global environment.Through these interactive case scenarios, participants will work in small teams to review scenarios and challenges associated with development, implementation and regulatory approval of matrix validation approaches for lyophilized products. Several different case studies will be provided and group input will allow for in-depth discussion of key points to consider.  Reinforcement of basic matrix validation approaches  Exposure and use of currently available (and accepted) technologies to assess key physical formulation characteristics  Increased understanding of regulatory concerns and requirements  Use of different approaches to assess multi-variate challenges in validation  4:00 Interactive Team Project - Sharing Ideas to Develop a MATRIX Meeting delegates will be given a problem scenario and a set of questions and discussion points. Delegates at each table will review scenarios and challenges associated with development, implementation and regulatory approval of matrix validation approaches. Table moderators will interrogate the issues and facilitate the discussion focused on the group乫s MATRIX design. Moderators: Edward H. Trappler, President and Founder, Lyophilization Technology, Inc. Jeff Schwegman, Ph.D., Founder/Chief Scientific Officer, BioConvergence LLC Palani Palaniappan, Ph.D., Senior Director, Pharmaceutical Sciences, Millennium Pharmaceuticals Robert Darius, Director, Global Quality Assurance, GlaxoSmithKline Biologicals Narlin Beaty, Ph.D., Managing Partner, Mechanical Engineering, Qualification Process Solutions, LLC

5:00 Closing Comments and Take Home Message

5:30 End of the Process Management Conference