Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process
06th November 2020 | 10:00 am EST | Oliver Steinhof, PAT Scientist at Biogen |BOOK FREE SEAT FOR THIS WEBINAR
Biogen is among the first biopharmaceutical companies to employ PAT in an active role in 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 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 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
Presented by Oliver Steinhof, PAT Scientist at Biogen
PAT Scientist at Biogen since 2017, supporting the startup of Biogen’s the new Next Generation Manufacturing facility at Solothurn Switzerland. Since 2015 responsible for the PAT laboratory at Lonza in Visp, Switzerland. Delivering PAT solutions and consulting services to the global organization, including small molecule API manufacture and chemicals. Since 2009 several roles at Shell Global Solutions in Hamburg Germany around lubricants R&D. Managed the analytical services team, acted as global technical support manager, internal consultant, internal quality auditor and as project leader for R&D projects. A chemist by training with stops at the Universities of Braunschweig Germany, Salt Lake City Utah and Tuscaloosa Alabama. PhD in industrial chemistry sponsored by BASF SE with a focus on on-line NMR spectroscopy and reaction engineering of complex polycondensations.