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Everything You Need to Know About Equipment Validation for Sterility Testing

Sterility Testing of Cell and Gene Therapy Products
ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene TherapiesJournal Club
14 Oct 2025 Lora Benoit Ph.D
As novel biologics and cell therapies advance, sterility testing is becoming increasingly complex and subject to cGMP scrutiny. Gebo et al. outline how clinical microbiology labs - traditionally CLIA/CAP-regulated - can align with FDA, USP, and ISO expectations.
Clinical & Veterinary Pharmaceutical

Reducing Uncertainty in Bioburden Testing: A Statistical Framework for Pharma QA

Reducing Uncertainty in Bioburden Testing
BioburdenJournal Club
08 Oct 2025 Lora Benoit Ph.D
In biopharmaceutical manufacturing, variability in bioburden testing poses significant challenges for maintaining product quality. Here, a statistical framework designed to improve the interpretation of bioburden test outcomes - enhance regulatory compliance and increase consistency.
Pharmaceutical

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