Kiniksa Pharmaceuticals

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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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QA/QC & Microbiology In-Depth Focus 2023

10 November 2023 | By European Pharmaceutical Review

This microbiology in-depth focus, explores sterility and bioburden testing considerations for cell and gene therapies.

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European Pharmaceutical Review Issue 5 2023

9 November 2023 | By European Pharmaceutical Review

EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.