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

摘要

As an essential milestone for both the cGMP for the 21~(St) Century and the recent pharmaceutical quality regulatory initiatives (Q8/Q9/Q10), the 2004 FDA Guidance for Industry "PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance" has proposed a science-based and risk-based regulatory pathway for pharmaceutical industry. Over the past 7 years the pace of implementation of PAT in small molecule drugs and biopharmaceuticals has been quite different. In this presentation, challenges and opportunities, technologies available as well as some scientific aspects of PAT real time process monitoring and control in biotech and biopharmaceutical area will be discussed based on several available case studies. In authors' opinion, when the pharmaceutical community is ready to embrace the challenges with enthusiasm, the benefits from implementing PAT in the biotech and biopharmaceutical area can be realized in the coming years.