Challenges and benefits integrating analyzers and predictive models in bench-scale cell culture
In process development for biopharmaceutical manufacturing, critical process parameters have to be identified and controlled to ensure high yields and consistent product quality. Pharmaceutical companies and regulatory authorities aim to implement Quality by Design (QbD)-strategies, in which Process Analytical Technology (PAT) facilitates the design, analysis and control of protein production.
The integration of “on†and “at-line†PAT technologies; process models and simulators; advanced control, and multivariate data analysis helps to gain an increased understanding of upstream bioprocesses and to optimize bioprocess performance.
In this webinar, experts from APC and the Eppendorf Bioprocess Center Europe discuss the challenges and benefits of PAT in biopharmaceutical process development.
A case study will be discussed, which will demonstrate the successful integration of a Raman spectrometer and an in-house-developed model predictive controller into a DASGIP® Parallel Bioreactor System.
Online analysis of a CHO mammalian cell culture process allowed the identification of glucose concentration as a critical process parameter. Based on increased process understanding, a continuous glucose feeding strategy was established, which resulted in an increase in peak viable cell density (VCD) and the integral of the viable cell density (IVC) which is directly related to increased titre."
Join Dr. Stephen Craven and Dr. Stephan Zelle, as they share insights on PAT integration in cell culture process development. Learn how an increased process understanding through online measurement and automated feedback control can simplify process operations and lead to a faster time-to-market.
Presented by
Stephen Craven, PhD,
Life Sciences Team Leader, APC Ltd, Dublin, Ireland
Dr. Stephen Craven earned his PhD from the School of Chemical and Bioprocess Engineering, University College Dublin, where he developed bioprocess models for mammalian cell fermentations and also developed and applied advanced control strategies to PAT enabled bioprocesses. Dr. Craven currently works as the life sciences team leader within APC Ltd, Dublin. APC is one of the world’s leading pharmaceutical process engineering research and development companies.
Dr. Stephan Zelle,
Product Manager Bioprocess, Eppendorf AG
Dr. Stephan Zelle is a Product Manager at the Eppendorf AG Bioprocess Center Europe. As part of this, he is responsible for research and development of seamless integrated software solutions for DoE, remote control, information management, and bioprocess controlling. During his PhD in the Forschungszentrum Jülich (Research Center Jülich) he performed parallel small-scale continuous fermentations for metabolic flux analysis and developed scripts and software for automated data processing.
