Microsaic Systems, the developer of point-of-need mass spectrometry instruments, has partnered with the Centre for Process Innovation (CPI), to demonstrate the potential use of Microsaic's MS instruments in bioprocessing.
Starting in January 2020, Microsaic will utilise CPI's UK biotherapeutics facility on a project that 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.
We are not aware of any other technology which can measure simultaneously small and large molecules in situ
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, 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 $200 billion), 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.
Glenn Tracey, CEO of Microsaic, said: "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.”