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Day 1 | Day 2
7:30am Morning Coffee (Breakfast Sponsored Presentation Opportunity Available)
8:25 Chairperson’s Remarks
Mark W. Thompson, R. Ph., Ph.D., Director, Vaccine Process Biochemistry, Vaccine Development, MedImmune, Inc.
8:30 Scale-Up of an Intensified Process for rAd35 Adenovirus Production using the PER.C6® Cell Substrate
Herman van Herk, M.Sc., Scientist, Up-Stream Process Development, Crucell Holland B.V.
Our recombinant tuberculosis adenovirus based vaccine (rAd35) is currently in several Phase I trials with promising results, and in a recently started Phase II study. Given the uncertainties required to develop a 10,000-liter facility and the need to develop a 10,000L scale viral vaccine manufacturing process, we are focusing on intensification of rAd35 manufacturing using the PER.C6® cell substrate. We will show a 10-fold intensification at bench scale and, for the first time, results of the scaled-up upstream process in 50L single-use bioreactors and the impact on cost of goods at production scale. Biography
9:00 Technical Challenges and Solutions for Development, Manufacturing Scale-Up and Management of Seasonal Strain Changes for Recombinant Influenza Vaccine
Albert Price, Ph.D., Technical Director, Influenza, Protein Sciences Corporation
FluBlok® (Protein Sciences Corporation) is a recombinant cell-based trivalent influenza vaccine produced using the baculovirus expression system. The product is currently under regulatory review by the FDA. An important challenge in the development of FluBlok was the implementation of a robust, cost-effective manufacturing process with the flexibility to respond quickly to annual influenza vaccine changes. This case-study will examine solutions to unique challenges encountered in manufacturing different influenza hemagglutinins, including: managing strain-change variations at key steps of upstream and downstream processing, key points for process optimization, and challenges anticipated for commercial scale manufacturing. Strategies for further improvement will also be discussed. Biography
9:30 Staying Live: Scale-Up of an Attenuated Respiratory Syncytial Virus (RSV) Vaccine
Mark W. Thompson, R.Ph., Ph.D., Director, Vaccine Process Biochemistry, Vaccine Development, MedImmune, Inc.
Respiratory Syncytial Virus (RSV) is an important respiratory pathogen of infants and young children, causing annual epidemics of bronchiolitis and pneumonia worldwide. Severe RSV illness commonly occurs among infants with primary infection in the first year of life and RSV is estimated to cause as much as 90% of all childhood bronchiolitis and up to 40% of all paediatric pneumonias. MedImmune is developing a cell culture-based production system for the RSV vaccine. A case study discussing the optimization of the manufacturing process, and challenges faced during development and scale-up strategies will be presented. Biography
10:00 Networking Coffee Break with Exhibit and Poster Viewing
10:45 After the License Approval - What Can Analytics Do?
C. Brent Oswald, Ph.D., Associate Director, VMSC–Bioanalytics, Merck Manufacturing Division
The talk will describe the application of analytical comparability to GARDASIL®, Merck’s novel new vaccine to prevent cervical cancer, in order to bridge product produced by a launch facility to that produced by a scale-up facility without the need for a clinical trial. This effort assured a smooth transition of supply and fulfilled marketing needs during the critical catch-up market phase for this product. In addition, the issues involved in modernization of release methods will be discussed. Of particular note will be the special issues for bridging potency assay procedures for legacy products. Biography
11:15 Industry Perspective on Handling the Complex and Sometimes Undefined Regulatory Requirements
Michael Dekleva, Ph.D., Senior Director, Worldwide Regulatory Affairs, Merck Sharp & Dohme Corporation
Past and recent experiences with vaccines have reinforced their medical and commercial significance, and the uniqueness of the process development and life cycle management challenges that they present to manufacturers. CBER and international regulatory authorities exist in a state of dynamic tension between their missions to rapidly introduce new products to satisfy unmet medical needs, and ensure patient safety. Manufacturers are likewise driven to expedite new vaccine introductions, and must satisfy expectations for vaccine quality, safety, and efficacy through well-orchestrated strategies for product development and global registration. Manufacturers must also establish and maintain a robust manufacturing, quality, and regulatory infrastructure to ensure an uninterrupted supply after launch. This presentation will provide practical insights into the strategic challenges associated with vaccine development and life cycle management. Biography
11:45 Meeting Regulatory Challenges through Better Characterization of Vaccine Production Substrates
Jonathan Liu, D.V.M., Ph.D., Director, Research & Development, Vaccine Development, MedImmune, Inc.
Recent scientific and technological advances have created new opportunities to develop vaccines and introduce new vaccine production substrates. In spite of large body of research data generated over the years, characterization of these new production substrates, especially those related with their use in vaccine production is still lacking. This has led to concerns and additional uncertainties during regulatory review and product approval. We shall discuss a novel approach that helps us to address some of these issues and assess tumorgenicity and oncogenicity of mammalian cells in vitro. Biography
12:15pm End of “Production & Manufacturing of Vaccines” meeting
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