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Wednesday, August 17
7:30 am Morning Coffee (Breakfast Sponsored Presentation – Opportunity Available)
8:25 Chairperson's Remarks
8:30 Meeting GMP Requirements for the Development of Autologous Dendritic Cell Based Therapeutic Vaccines
Lee K. Roberts, Ph.D., President, Roberts Biotech Consulting, Co-Director of GMP at the Baylor Institute for Immunology Research
For most disease targets the objective of immunotherapeutic vaccines is to stimulate an effective antigen-specific CD8+ cytotoxic T-cell (CTL) response. It is well recognized that dendritic cells (DC) are potent antigen-presenting cells. Work conducted at the Baylor Institute for Immunology Research (BIIR) has established a variety of processes for manufacturing autologous DC vaccines for treating patients with cancer and viral diseases (AIDS). The effectiveness of these immunotherapeutic DC vaccines is, in part, dependent on their ability to elicit CTL responses in patients undergoing treatment.
Several clinical trials have been initiated to evaluate the efficacy of these DC vaccines. In order to conduct these clinical studies it was imperative for BIIR to establish Good Manufacturing Practices (cGMP) that were compliant with FDA requirements to manufacture and release these investigational DC vaccines for human use. BIIR has focused on key areas to achieve and maintain cGMP compliance, including; establishing an independent Quality Assurance Unit, developing critical Standard Operating Procedures, continuous efforts in staff training, and validation of the Phase I/II cGMP facility. Through these on-going efforts BIIR has improved the quality and consistency of the DC vaccine products under investigation.
9:00 Operational & Compliance Aspects of Autologous Vaccine Production
Stephen Monks, Ph.D., Vice President, Manufacturing, Process & Analytical Technologies, Agenus, Inc.
Registered in Russia as Oncophage® (Prophage R-100) for the treatment of intermediate risk renal cell carcinoma and being developed in several indications including both newly diagnosed and recurrent glioblastoma multiforme (Prophage G-100 and G-200, respectively), the Prophage series of heat shock protein based vaccine candidates represent a unique autologous approach with potentially broad application to the immunotherapeutic treatment of all cancer types. The product, a peptide-protein complex, delivers tumor-specific antigens to antigen presenting cells, evoking T cell–mediated antitumor immune responses. While many operational aspects are in common with traditional biologics, unique factors drive the development and commercialization of autologous vaccines. Success relies on efficient processes for individual tumor procurement, patient-specific product manufacture and release, and ensuring chain of custody and integrity for each unique tumor and resulting vaccine. Factors driving autologous manufacturing, including the concept of scale-out (and not up), logistics and controls and the underlying compliance landscape will be presented.
9:30 Navigating The Challenges of Highly Personalized Cancer Vaccine Production Using Autologous Tumor and Dendritic Cells
Daniel J. Powell Jr., Ph.D., Ovarian Cancer Research Center, Research Assistant Professor - Path & Lab Medicine, SOM, Deputy Director Cell & Vaccine Production Facility, University of Pennsylvania
Dendritic Cells are professional antigen presenting cells capable of inducing robust immune responses to specified antigens and thus have potential for use in cancer vaccination. One major obstacle to successful immunotherapy is the choice of tumor antigens for stimulating potential tumor-rejection response. Tumors themselves express a broad array of immunogenic antigens, including characterized shared antigens and unique mutated antigens of unknown identity, and therefore represent an optimal source of patient-tailored immunogen. The use of autologous tumor lysates and dendritic cells in combination thus holds significant promise for the creation of highly-personalized therapy yet presents novel challenges, as well as opportunities, for vaccine optimization and production.
10:00 Networking Coffee Break with Exhibit and Poster Viewing
10:45 Quality by Design in Influenza Vaccine Development and Manufacturing
Susan Dana Jones, Ph.D., Vice President, BioProcess Consultants
Since the components of influenza vaccines must be modified each year depending on the relevant infectious strains or antigens, it is important to develop robust manufacturing platformsfor these vaccines that can be readily adapted each year within an existing regulatory framework. Given the fast pace required for annual re-optimization and validation of influenza vaccine processes, whether they be based on traditional egg-based methods or emerging cell-based strategies, the principles of Quality by Design can be applied to better understand process variables, reduce process risk, and ensure appropriate product yield and quality.Case studies and analyses will be presented describing the use of QbD to enable process development of seasonal influenza vaccine manufacturing processes.
11:15 Use of Multivariate Experiments During Vaccine Process Development and Process Improvement
Jason Murphy, Ph.D., Process Engineer, Viral Vaccine Process Development, Merck & Co.
A tenet of modern process development has been the use of multivariate experimental design to decrease resource needs and increase experimental robustness related to process development and process improvement. When applied to vaccine process development there are subtleties from product to product that need to be carefully evaluated. This discussion will focus on example process development and improvement experiments. Keys to success are defining proper process set points and ranges coupled with speed and flexibility that result in a robust and well-defined process.
11:45 End of Production & Manufacturing of Vaccines
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