Process Validation in Support of Manufacture of a Bacterial Toxin

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The Health Protection Agency's Process & Analytical Development Group (PADG) has completed studies for an international Biopharm company to support validation of a bacterial toxin manufacturing process. The product is a therapeutic form of a botulinum toxin and was originally developed and manufactured in HPA’s GMP manufacturing facilities at Porton Down. The validation studies were on the downstream processing stages of the process using scaled down models.