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Navigating the ISPE Good Practice Guide: Cold Chain Management in 2026
"This guide examines the core principles, thermal qualification protocols, and quality risk management methodologies outlined in the International Society for Pharmaceutical Engineering (ISPE) Good Practice Guide: Cold Chain Management alongside complementary guidance for Controlled Temperature Chambers. Maintaining end-to-end product quality during storage, transit, and distribution is a foundational mandate across the biopharmaceutical sector. As advanced therapy medicinal products (ATMPs), mRNA-based therapeutics, monoclonal antibodies, and personalized vaccines dominate modern development pipelines, cold chain systems face unprecedented re..."
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