FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
May 16-17, 2001
SLIDES
Wednesday, May 16
Session 2 – OPEN Session – Use of Novel ("Designer") Cells as Substrates for Manufacture of Viral Vaccines
Introduction to the Session on Designer Cell Substrates, Andrew M. Lewis Jr. MD, FDA pdf
Immunological Determinants of the Tumorigenicity of Adenovirus-Transformed Cells, James Cook pdf
Quantitative Assessment of the Risks of Residual DNA, Dr. Keith Peden, FDA pdf
Introduction to Adventitious Agent Issues Dr. Philip Krause, FDA pdf
Transmissible Spongiform Encephalopathy (TSE) or Prion Diseases, Dr. Sue Priola, NIH pdf
Review of OVRR-CBER Issues with the Use of Adenovirus-vectored Vaccines and their Complementing "Designer Cell Substrates" Dr. Hana Golding, FDA pdf