Challenge of Adventitious Agent Control
作者： John Geigert
DOI: 10.1007/978-1-4614-6916-2_4
关键词: Bioburden 、 Risk Control 、 Biology 、 Biopharmaceutical 、 Infectious agent 、 Biotechnology
摘要: The primary adventitious agents of concern for biologics are examined in detail—prions, viruses, mycoplasmas, and bacteria/fungi microbes. three major risk control procedures these contaminating agents—barriers to entry, testing confirm absence, inactivation/removal—are discussed. Risk examples provided animal-derived materials used biologic manufacturing, cell culture manufacturing processes, biopharmaceutical production transgenic animals plants, natural sourced human plasma-derived proteins, virus-based biologics, cell-based medicines. In addition, lessons learned from previously reported infectious agent contaminations presented. Finally, some CMC strategic tips minimizing the overall contamination biologics.
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