Process analytical technology (PAT) has been defined by the United States Food and Drug Administration as a mechanism to design, analyze, and control biologic manufacturing processes through the measurement of critical process parameters (CPPs) which affect critical quality attributes (CQAs). The goal of PAT is to have quality built into the process, quality by design (QbD), for better process understanding and control. Raman spectroscopy provides great potential for real-time and in situ measurement of relevant cell culture process parameters and product quality attributes. Consequently, upholding the QbD initiative.
In this webinar, you will:
- Discover case studies on the implementation of Raman spectroscopy soft-sensors for monitoring in bench-scale CHO cell intensified seed trains (N-1), steady state, and dynamic perfusion(N) cultures
- Understand the value of combining automated sampling with Raman spectroscopy for increased sample frequency, leading to more accurate measurement of CPPs and CQAs in the upstream bioprocess
Speaker
Rakesh Bobbala
Merck
Applications Engineer
Rakesh Bobbala works as an applications engineer at Merck. Currently, he is working on developing PAT tools for improved process understanding and process control in upstream bioprocessing. Rakesh has a master’s degree in biomedical engineering from the University of Wisconsin-Madison and a bachelor’s degree in chemical engineering from the National Institute of Technology, Warangal. His other fields of interest are perfusion process development, process modeling, and developing digital tools to enable the smart manufacturing of therapeutics.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duración:1h
Idioma:English
Sesión 1:presentado October 20, 2022
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