QA/QC & Microbiology In-Depth Focus 2023

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

  • Bioburden and sterility testing: how to conserve gene therapy product
    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.
  • Developing micro QC for ATMPs
    Natalie Saunders, Interim Head of QC at CGT Catapult, delves into the advancements and challenges in microbiological QC for cell and gene therapies. She discusses rapid sterility testing methods, regulatory frameworks, and the impact of automation and digitalisation on microbiological quality control.
  • Whitepaper: The value and benefits of rapid mould detection in the pharmaceutical industry
    Addressing the importance of accurate microbial identifications and proper contamination control for effective mould remediation.