贵州省委贵州省12.pptVIP

Adventitious Agent Testing of Novel Cell Substrates for Vaccine ManufactureArifa S. Khan, PhD.Division of Viral ProductsOffice of Vaccines Research and ReviewCBER, FDANovember 16, 2005;Outline Cell substrates used in U.S. licensed viral vaccines Safety concerns and challenges for testing novel cell substrates, especially tumorigenic cells FDA experience with tumorigenic cell substrates Testing recommendations for novel and tumorigenic cell substrates, such as Madin-Darby canine kidney (MDCK) cells;Types of Cell Substrates Used in Current U.S. Licensed Viral Vaccines;U.S. Licensed Viral