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Challenges, Opportunities, and Scientific Aspects of Implementing PAT in Biopharmaceuticals

机译:在生物制药中实施PAT的挑战,机遇和科学方面

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As an essential milestone for both the cGMP for the 21~(st) Century and therecent pharmaceutical quality regulatory initiatives (Q8/Q9/Q10), the 2004 FDAGuidance for Industry “PAT-A Framework for Innovative PharmaceuticalDevelopment, Manufacturing, and Quality Assurance” has proposed a science-based andrisk-based regulatory pathway for pharmaceutical industry. Over the past 7 years the paceof implementation of PAT in small molecule drugs and biopharmaceuticals has beenquite different. In this presentation, challenges and opportunities, technologies availableas well as some scientific aspects of PAT real time process monitoring and control inbiotech and biopharmaceutical area will be discussed based on several available casestudies. In authors’ opinion, when the pharmaceutical community is ready to embrace thechallenges with enthusiasm, the benefits from implementing PAT in the biotech andbiopharmaceutical area can be realized in the coming years.
机译:这是21世纪cGMP和 最近的药品质量监管计划(Q8 / Q9 / Q10),2004年FDA 工业指导“ PAT-创新药物框架” 开发,制造和质量保证”已提出了基于科学的 制药行业基于风险的监管途径。过去7年的步伐 在小分子药物和生物制药中实施PAT的经验 很不一样。在本演讲中,挑战与机遇,可用技术 以及PAT实时过程监控中的一些科学方面 生物技术和生物制药领域将根据几种可用案例进行讨论 学习。作者认为,当制药界准备好接受 热情挑战,在生物技术中实施PAT的好处以及 生物制药领域可以在未来几年实现。

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