Microsaic Systems plc (LON: MSYS), the developer of point-of-need mass spectrometry instruments, has announced that has partnered with the Centre for Process Innovation (“CPI”), utilising the CPI’s UK biotherapeutics facility, to demonstrate the potential use of Microsaic’s MS instruments in bioprocessing.
Starting in January 2020, the project will take approximately 12 months and will deliver an on-line, and real-time method for bioreactor chemical analysis and control. Directly interfaced with the bioreactor, Microsaic’s point-of-need MS detector will be integrated with “closed-loop” software which will control the overall system, and will provide continuous, real-time control of the biomanufacturing process, including the provision of additional data analytics for quality monitoring and assurance.
The CPI connects academia, businesses and funders to bring bright ideas and research into the marketplace. It offers facilities across a network of sites which provide equipment and technical expertise that help companies to develop next-generation products and processes. One such facility is the National Biologics Manufacturing Centre, a state-of-the-art facility which aims to significantly increase the UK’s manufacturing capability in biologics (medicines produced from biological sources such as proteins and DNA). The centre promotes industry collaboration across the supply chain, from research through to manufacture and commercialisation.
Biopharmaceuticals is a well-established and rapidly growing sector (currently valued at circa $200Bn), which faces significant challenges around process robustness. This is particularly within upstream processing, which relies on fundamental biology and carries inherent product variability. Point-of-need MS would provide timely and critical safety assurance, as adverse effects would be identified and mitigated upstream.
The analytical instrumentation market in upstream bioprocessing alone is projected to be worth circa $390M in 2020*. The Company believes that its compact, easy-to-use, MS technology is well-positioned to access a share of this market, working with bioprocessing instrument providers and end-users in biopharmaceutical manufacturing alike.
Glenn Tracey, CEO of Microsaic Systems, commented,
“We are very pleased to be working with the CPI on this project, which brings together our combined expertise in analytical instrumentation and biologics manufacturing. Importantly, we are not aware of any other technology which can measure simultaneously small and large molecules in-situ, enabling real-time bioreactor control within a closed loop system. End-user validation, which will be available throughout the project, will be a very important mechanism for connecting us to significant end-markets.
“The biomanufacturing industry faces increasing demands from regulatory agencies, wanting better analytics to provide appropriate process monitoring and control methods during the manufacture of biologics. We believe that this MS-based intelligent solution could enable key process parameters to be determined based on real-time and historic data to satisfy these demands.
“Microsaic’s point-of-need MS solution facilitates the adoption of closed-loop control which is designed directly into the biomanufacturing process. Ongoing market and customer feedback reassures us that our offering is ahead of all others in the field, and the point-of-need differentiation utilising our proprietary miniaturised technology positions Microsaic favourably to gain traction in this new, high-growth application area.”
*Report on upstream bioprocessing analytical instrumentation, TDA consultants 2019