eBook: Aseptic Processing — Reflections from the 2023 ISPE Aseptic Conference

Biopharmaceutical products must be sterile. Protein biologics and now advanced-therapy medicinal products (ATMPs) usually are administered in ways that bypass patients’ natural immune defenses. Therefore, such drugs increase risks for introducing contamination to their recipients. Because terminal sterilization can destroy biological products, aseptic manufacturing is the primary means for ensuring drug-product sterility. However, aseptic processing involves many more variables than does terminal sterilization, making it imperative for drug manufacturers to keep abreast of emerging techniques for aseptic processing and evolving regulatory guidances.

In this eBook, a commissioning, qualification, and validation (CQV) subject-matter expert from regulatory consultancy PharmaLex provides valuable impressions from the 2023 International Society for Pharmaceutical Engineers (ISPE) Aseptic Conference in Bethesda, MD. The meeting convened presenters and delegates from the world over to discuss recommendations for aseptic-process simulation (APS), novel isolator and restricted-access barrier (RABS) systems, implications of the 2022 update to Annex 1 of the EU good manufacturing practice (GMP) guideline, and more. Read the eBook now to learn about key concepts in aseptic processing and current trends in their application, including special considerations for aseptic processing of ATMPs.

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