Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process
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.
Presenter: Oliver Steinhof (Global Lead PAT, Biogen)
Supporting the Digital Development and Analytics team at Biogen since 2017 with a focus on PAT implementation and commercialization. Focus over the last 4 years was the startup of Biogen’s Next Generation Manufacturing facility at Solothurn Switzerland. Since 2015 at Lonza Visp, Switzerland, leading the PAT laboratory and providing PAT consulting and solutions to the global Lonza network, including small molecule API manufacture and chemicals. Since 2009 several roles at Shell Global Solutions in Hamburg Germany around lubricants R&D, including management of the analytical services team, global technical support manager, internal consultant, quality auditor and project leader for R&D projects. Chemist by training, spending time 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.
Presenter: Martin Gadsby (Owner and Director, Optimal Industrial Automation)
Martin graduated from the University of Bath in the late 1970’s, and after working through a few positions in industry, he became the European R&D Process and Process Automation Group Leader for Kraft Foods. After a few years at Kraft, Martin decided to set up a process automation business with a colleague, Dave Richards, and Optimal was born. Optimal Industrial Automation was formed over 33 years ago, with Martin now being the Vice President of Optimal Industrial Technologies which was formed more recently as the products division and is the market leader in the field of Process Analytical Technology (PAT) with its PAT Knowledge Management product – synTQ. Martin is intimately involved with progressing the evolution of synTQ and advising the Optimal development team on what he believes to be the optimum development direction. Over the last few years, he has taken on the overall responsibility not only for the company but also for the sales and marketing of synTQ whilst remaining very active in ensuring that the development of synTQ continues unabated. On the personal front, Martin is a bit of a ‘petrol head’ and enjoys flying aerobatics and racing cars.
