GSK has a comprehensive viral safety program for the production of biopharmaceutical which uses a three-fold complementary approach:

  1. Control of Raw Materials

  2. In Process Testing

  3. Demonstration of capability of processing steps to clear virus

These and other considerations are tightly managed through a comprehensive risk management program that has resulted in confidence that the materials that are supplied to patients are free from virus contamination.


Speakers:

Anne Stokes, PHD
GlaxoSmithKline

Dr. Anne Stokes is a GlaxoSmithKline (GSK) Senior Fellow, a member of the Council of Fellows and currently the Director of TSE and Virus Control within GMP Operations, Biopharmaceutical Product Development and Supply in Pennsylvania. For the past 21 years, she has worked for GSK, in the development and manufacture of biopharmaceuticals and cell and gene therapy products. She has experience in Cell Banking & TSE, virus safety of biopharmaceuticals, and is responsible for the oversight of TSE and virus safety of a Biopharm GMP manufacturing facility. She received a Doctorate in Viral Immunology whilst at the Pirbright Institute Surrey, UK. As a Fogarty Fellow at the NIH she worked on a vaccine for human parainfluenza virus 3. She is currently a member of the PDA.


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