Webinar Overview
Biogen is among the first biopharmaceutical companies to employ PAT in an active role in the manufacturing of biologicals. The implementation of in-process Raman for glucose control, biocapacitance for in-line cell growth monitoring as well as in-line refractive index and other univariate techniques for the automatic in-line release of process solutions is being discussed. GMP-specific considerations such as risk assessment, data integrity and qualification strategy are presented as well.
The application of PAT in an active role as part of the control strategy in commercial production in a cGMP compliant environment is not yet done very frequently in the biopharmaceutical industry. This is due to a combination of risk factors which typically involve regulatory challenges, technology maturity and economic benefit. Biogen decided to employ PAT at large scale mammalian cell culture at its new manufacturing site at Solothurn, Switzerland. Biogen’s Aducanumab process has shown to benefit significantly from direct PAT control. Inline Raman spectroscopy and inline biocapacitance are used to actively control the feed of glucose and nutrients to the production bioreactor. The glucose concentration is predicted using a validated PLS model and is used as input for a closed loop control device that is controlling the addition of glucose solution to the bioreactor in a virtually continuous manner.
This webinar is copyright of Biopharma Webinars.
ON DEMAND SESSION
Friday, November 6, 2020
Speakers
Oliver Steinhof
Global Lead PAT, Biogen
Martin Gadsby
