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 and Martin Gadsby, Owner, Optimal Industrial Automation Ltd |WATCH FOR FREE
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.
Followed by Martin Gadsby, Owner, Optimal Industrial Automation Ltd
Martin graduated from the University of Bath in the late 1970’s, and after working through a few positions in industry, he became the new 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 main owner and CEO. Optimal Industrial Technologies 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
Sponsored by Optimal Industrial Automation
Within the Optimal group we have more than 30 years’ experience in the automation and optimisation of control and data management systems for the pharmaceutical, biotech and life science industries with significant experiences in both batch and continuous processing. The demands being placed on manufacturers in relation to getting products to market sooner, minimising development and production costs together with increasing product quality and business sustainability are ever increasing; hence, the company’s primary aim is to deliver measurable improvements in all these target areas and has, though the years, developed many innovative solutions and approaches.
In addition to practical automation and system integration expertise, Optimal Industrial Technologies has also developed the world-leading PAT Knowledge Management software platform – synTQ® which is used by over 60% of the world’s leading pharmaceutical and biotech companies. It has been a proven enabler of QbD via PAT by significantly increasing productivity and quality whilst reducing time to market, waste plus time to manufacture for batch and continuous processes. It is being applied from the laboratory through to full GMP manufacture in small and large molecule drug substance and drug product processes and has assisted in cutting weeks from manufacturing times and in some cases, tripling production capability.