Kathy Zagaroli (Kiniksa Pharmaceuticals)

Bioburden and sterility testing: how to conserve gene therapy product

19 December 2023 | By Kathy Zagaroli (Kiniksa Pharmaceuticals), Tom Bujold (REGENXBIO)

Here, Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.

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Kathy Zagaroli (Kiniksa Pharmaceuticals)

Bioburden and sterility testing: how to conserve gene therapy product