Open Access. Powered by Scholars. Published by Universities.®
Biomedical Engineering and Bioengineering Commons™
Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 3 of 3
Full-Text Articles in Biomedical Engineering and Bioengineering
Moving From A Bioreactor Scale-Up/Scale-Down Approach To A More Holistic Operational Design Space View, Gene Schaefer, Rick Yeager, Ted Deloggio
Moving From A Bioreactor Scale-Up/Scale-Down Approach To A More Holistic Operational Design Space View, Gene Schaefer, Rick Yeager, Ted Deloggio
Cell Culture Engineering XV
Scale-up of bioreactor processes for biologic products has been an area of focus in the industry for over 50 years and the results have generally been successful through the application of a number of specific correlations across scales for mass transfer, mixing, etc. However, the ability to visualize and understand the bioreactor design space in terms of these parameters has generally been limited as has any general understanding of how close a given process comes to certain sensitivity limits at various scales. As part of a project which involved establishing scale-down models at two different sites with long-term objectives of …
Development Of A Process Analytical Technology (Pat) Infrastructure For Future Biologics Upstream Processing, Mathieu Steefland
Development Of A Process Analytical Technology (Pat) Infrastructure For Future Biologics Upstream Processing, Mathieu Steefland
Cell Culture Engineering XV
Process Analytical Technology (PAT) involves the timely analysis of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) with the aim to improve the process control strategy resulting in a better process performance and robust product quality. The progress of PAT implementation in upstream bioprocessing has been slow mainly due to the complexity of the process steps with many parameters involved, and the complexity of the product and the culture medium. While the first approved PAT-based Real Time Release application in the small molecules field already celebrating its 10th anniversary in 2016, PAT for upstream bioprocessing is only now maturing. …
Application Of Online Co2 Monitoring To Enable A Better Understanding Of Cell Culture Performance Variation Between Gmp-Scale And Scaled-Down Bioreactors, Ting Kuo Huang, Jacob Mauger, James Dvornicky
Application Of Online Co2 Monitoring To Enable A Better Understanding Of Cell Culture Performance Variation Between Gmp-Scale And Scaled-Down Bioreactors, Ting Kuo Huang, Jacob Mauger, James Dvornicky
Cell Culture Engineering XV
Dissolved carbon dioxide (dCO2) or partial pressure of carbon dioxide (pCO2) is an important process parameter that may impact process performance (product titer and viability) and product quality attributes (such as glycosylation) during mammalian cell culture process in a bioreactor. The impact of altered level of pCO2 on the cell culture process may manifest itself upon process scale-up if the CO2 removal rate is not consistent between the development scale and the manufacturing scale. The pCO2 level during cell culture process is normally determined through offline measurement; however, the offset between online and …