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

  • Type:
    Conference Presentation
  • Conference Type:
    AIChE Annual Meeting
  • Presentation Date:
    October 19, 2011
  • Skill Level:
  • PDHs:

Share This Post:

Once the content has been viewed and you have attested to it, you will be able to download and print a certificate for PDH credits. If you have already viewed this content, please click here to login.

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.



Do you already own this?

Log In for instructions on accessing this content.


AIChE Member Credits 0.5
AIChE Members $15.00
AIChE Undergraduate Student Members Free
AIChE Graduate Student Members Free
Non-Members $25.00