Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process - Seguridad Mania.com - España y América Latina

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