蛋白制剂制造会议 - Day 2

概要 | 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 Protein Aggregation and Bioprocessing
Mary Cromwell, Senior Research Pharmaceutical Associate, R&D, Genentech Inc.

8:50 From Small-Scale Development to Large-Scale Manufacturing of Immunglobulins from Human Plasma
Wolfgang Teschner, Ph.D., Director Research, Plasma Product Development / Product Support, R&D Austria, BioPharmaceuticals, Baxter AG
Each year tons of immunglobulins are purified out of human plasma. Purification processes have to combine robustness in large-scale manufacturing and adequate virus reduction of all types of viruses with a maximum IgG yield and purity. The final product has to be easy to apply, efficacious, and well tolerated. Unchanged process parameters during scale-up to preclinical, clinical and routine lot manufacturing assure the consistency of the results from each development stage.

9:20 Single-Use Processes for Production and Scale-up of Biologics 
Leigh Pierce, President, PacificGMP
The need to manufacture large quantities of material in a short period of time is the goal for most companies striving to get their product into the clinic. Single-use, disposable components offer many advantages in the manufacturing of such biologics in the areas of cleaning, sterilization, validation, cost, flexibility, set-up and fast turn-around time between runs. This presentation will introduce and discuss real applications of single-use technology.

9:50 Coffee Break in the Exhibit Hall

10:45 Poster Awards in Exhibit Hall

11:00 Review of Cell Culture-Based Biomanufacturing--Future Perspectives of Antibody Manufacturing
Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec Inc.
My presentation will be an overview of approximately 20 years of successful biomanufacturing in cell culture technology, and 乬state-of-the-art乭 biomanufacturing processes and products. I will address the paradigm shift in facility design, multi-use facilities, and making use of efficient and flexible biotech plants in the future, which will include the global manufacturing challenges that we have to manage. Specific emphasis will be given to the current situation with a focus around known and 乬perceived乭 bottlenecks, 乬high titer,乭 product stability, and an overview of current and future therapeutic areas for antibody therapy.

11:30 Highly Efficient Expression of Recombinant Proteins in PER.C6 Cells: Impact on the Design of Manufacturing Facilities. 
Marco A. Cacciuttolo, Ph.D., Chief Executive Officer, PERCIVIA LLC
Due to the highly efficient nature of PER.C6® cells both (1) to grow in suspension cultures at extremely high cell densities and (2) to express recombinant product on a per-cell basis without the need for amplification at high specific yields, the PER.C6® Technology Platform has to address the need to manufacture, recover, and purify proteins economically and efficiently. In this presentation, a revolutionary concept for making biologics in small footprint facilities, using disposable technologies is discussed. This design takes advantage of the high specific productivity in each of the Upstream and Downstream unit operations achieved when using the PER.C6® Technology Platform. 

12:00pm A Case Study: Manufacture, Conjugation, and Process Improvement of a Rhenium-188-Labelled Anti-Melanin Antigen Monoclonal Antibody for Radioimmunotherapy of Melanoma 
Muctarr Sesay, Ph.D., Senior Director, Process Development, Goodwin Biotechnology, Inc.
Due to their large size, IgM monoclonal antibodies possess significant challenges in their manufacture, including low cell culture yields, molecular instability, limited purification options, modification and characterization. For example, most IgMs do not bind rProtein A or G immobilized onto an inert solid support which requires that they be affinity purified to achieve >90% purity and significant reduction of contaminants (such as host cell proteins, Nucleic Acids, and endotoxins) for therapeutic uses. This presentation will focus on a current project case study and will describe strategies involving the cell culture production, the development of a purification process that does not require the costly and difficult use of affinity columns, fast and efficient conjugation/modification of the IgM monoclonal antibody and radiolabelling of the modified antibody with rhenium-188. The Rhenuim-188 labeled IgM is currently undergoing Phase 1 clinical studies for therapy against melanoma skin cancer.

12:30 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 Protein Production Conference