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Attend a comprehensive program lead by top scientists in industry and the FDA presenting big pharma and biotech approaches to the challenges of cost effective, commercially viable vaccine production. Presentations focus on vaccine production from a variety of novel sources, process development, optimization and validation, and also measures to control product quality. The scale-up session will include the handling of a rapid response to seasonal flu and potential pandemics. The event will also focus on analytical studies to ensure product quality at all stages of development together with industry and regulatory perspectives on handling manufacturing process change.
Opening Keynote Presentation:
Regulatory Authority Perspective on Handling Vaccine Production, Manufacturing and Process Change
Norman Baylor, Ph.D., Director, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, FDA
Industry Perspective on Handling the Complex and Sometimes Undefined Regulatory Requirements
Michael L. Dekleva, Director, Worldwide Regulatory Affairs, Merck, Inc.
Scale-Up of an Intensified Process for Rad35 Adenovirus Production Using the PER.C6 Cell Substrate
Alfred Luitjens, Senior Scientist, New Technology, Crucell
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
Case Study on Scale-Up of Production from Bench to Commercialization
Rinaldo Zurbriggen, Ph.D., Senior Program Manager, Lonza AG (Formerly CSO of Pevion Biotech)
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.
Gaining Control and Determining Specifications of the Process
Speaker to be Announced
Designing and Validating a Manufacturing Process
Trevor Deeks, Ph.D., Senior Director, Manufacturing Support Group, Contract Manufacturing Group, Emergent BioSolutions, Inc.
Advances in Purification Technology
Speaker to be Announced
Manufacturing a Sterile, Autologous Colon Tumor Derived Vaccine for a Patient-Specific Immunotherapeutic Treatment
Michael Hanna, Ph.D., Chairman and CEO, Vaccinogen, Inc.
Managing Aggregation of VLP and Viral Vaccines
Speaker to be Announced
Measures to Reduce Cost of Goods in Vaccine Manufacturing Particularly in Implementing Change
Speaker to be Announced
Production of Influenza Vaccines Using a Fungal Production Platform
Debbie Higgins, Ph.D., Vice President, Vaccine Development, Neugenesis Corporation
Spray Drying in Vaccine Manufacturing for Improved Stability
Tom Jin, M.D., Scientist, Principal Investigator, Technique Operations & Manufacturing, Aeras Global TB Vaccine Foundation
Quality by Design for Maintaining Quality and Potency of the Product and for Risk Analysis
Speaker to be Announced
Change Control Assays to Ensure Consistent Antigen and Product Characteristics
Speaker to be Announced
After the License Approval - What Can Analytics Do?
Robert D. Sitrin, Ph.D., Executive Director, GVTE-Bioanalytics, Merck Manufacturing Division
Characterization of the Product to Satisfy the Regulatory Authorities
Jonathan Liu, D.V.M., Ph.D., Director, R&D, Vaccine Development, MedImmune, Inc.