Challenges, Opportunities, and Scientific Aspects of Implementing PAT In Biopharmaceuticals | AIChE

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

Type

Conference Presentation

Conference Type

AIChE Annual Meeting

Presentation Date

October 19, 2011

Duration

30 minutes

Skill Level

Intermediate

PDHs

0.50

As an essential milestone for both the cGMP for the 21st 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 of implementing PAT in biotech and biopharmaceutical area can be realized in the coming years.

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