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Lindsey Silva

Director Microbiology

Advancing 3R Principle for Animal Welfare while Maintaining Patient Safety for Biologic Medicines

Science

Quality Control testing of biologic medicines for parenteral administration is important to ensure the safety of life saving medicines for patients. Animal testing has historically been used to verify that biologic medicines are free from microbial contaminations. With advances in new technologies, sustainable methods are now available that meet the 3R principle for animal welfare (Replace, Reduce, Refine) while maintaining patient safety. This presentation will give an overview of Recombinant Factor C and the Monocyte Activation Test to test for the presence of endotoxin and non-endotoxin pyrogens as sustainable methods to replace the horseshoes crab blood-derived endotoxin and rabbit pyrogen test methods.

Meet the Speaker:

Lindsey Silva, Ph.D. is the Director, Microbiology in Analytical Sciences, Pharma Quality and Compliance at Genentech, a Member of the Roche Group. Dr. Silva is a highly skilled analytical scientist with over 10 years of industry experience with a track record of developing and implementing technology to build agility for biologic products. Our team is responsible for driving analytical innovation and QC microbiology solutions, including end-to-end microbial oversight of a growing small molecule parenteral portfolio. Dr. Silva joined Genentech in 2015 as a technical development scientist responsible for virus clearance studies and development of virus testing technologies. She loves using her virology and microbiology expertise to ensure that life saving medicines are safe for patients. Dr. Silva is passionate about diversity and inclusion to drive innovation. She is a board member of Genentech Women in Science and Engineering (gWISE) and a board member of the non-profit ADDSTEAM. Dr. Silva received her Bachelor of Science in Biology from UC Irvine, Ph.D. in Microbiology and Molecular Genetics from Harvard Medical School, and post-doctoral training from USC Keck School of Medicine.

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