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Review of Developments in GMP and the Regulation of Medicines August 2025  EJPPS vol 30.3B  This month reported issues have come from the...

Polysorbates (PS), particularly polysorbate 20 (PS20) and polysorbate 80 (PS80), are widely utilized as non-ionic surfactants in biopharmaceutical formulations. Their primary role is to stabilize therapeutic proteins against interfacial stresses encountered during manufacturing, handling, and storage. Despite their widespread use, PS are complex and heterogeneous mixtures prone to degradation. The two primary degradation pathways are hydrolysis and oxidation. Hydrolytic degra

Biological indicators of Geobacillus stearothermophilus spores, inoculated on stainless steel carriers within Tyvek® primary packaging are used as a challenge of efficacy for a bio-decontamination cycle during cycle development, performance qualification and subsequent re-qualification, typically to verify a VHP/vH₂O₂ bio-decontamination cycle meets 6log sporicidal requirements.