Microsaic Regulatory News (MSYS)

02 July 2021

Microsaic Systems plc

("Microsaic" or the "Company")

Microsaic demonstrates real-time monitoring for scaling biotherapeutic production

Automated system maintains high quality while allowing rapid scaling to large volumes.

Microsaic (AIM: MSYS), the developer of point of need mass spectrometry ("MS") instruments, in collaboration with the Centre for Process Innovation ("CPI"), is delighted to announce the development and demonstration of the first, real-time monitoring Process Analytical Technology ("PAT") MS solution for the on-line production of biotherapeutic drugs such as vaccines and anti-cancer treatments.

Live data transmitted via Internet of Things ("IoT") devices from the micro-engineered MS equipment, enables constant monitoring of production processes, to ensure high quality biological production output. This real-time alert system allows rapid scaling to large volumes, reduces supervision costs, and accelerates vaccines and anti-cancer treatments through emergency and standard regulatory authorisation and direct to patients.

Glenn Tracey, CEO of Microsaic Systems plc, commented:

"As part of the recent G7 directive to deliver faster production of vaccines and treatments to manage the current and future pandemics, we are delighted to have achieved this significant milestone. In just a short time we have demonstrated and delivered an efficient automated production scaling methodology to fast-track drugs and vaccines to market, at a lower cost of production and without manual human intervention, whilst maintaining consistent high quality.

"We are not aware of any other technology that can simultaneously analyse small and large molecules as part of on-line production. We expect to interface with end-user manufacturing processes during H2 of this year, and we look forward to augmenting our system with further advanced AI tools in our drive to remain at the cutting edge of technology in the Industry 4.0 era."

Background to the Technology:

Directly interfaced with a bioreactor and autosampler, Microsaic's micro-engineered and fully portable MS detector has been integrated with process control software, to provide continuous, real-time analysis of the biomanufacturing process, including the provision of additional data analytics for quality monitoring and assurance. 

Biopharmaceuticals is a well-established and rapidly growing sector (currently valued at circa $200 billion1), which faces significant challenges around process robustness. This is particularly apparent within upstream processing, which relies on fundamental biology and carries inherent product variability. Point-of-need MS would provide timely and critical safety and quality assurance, as adverse effects would be identified earlier in the process and mitigated upstream. 

The analytical instrumentation market in upstream bioprocessing alone is projected to be worth circa $390 million in 20202. 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.

12020 Global Life Sciences Outlook, Deloitte

2Report on upstream bioprocessing analytical instrumentation, TDA consultants 2019

About Microsaic (www.microsaic.com)

Microsaic listed on AIM in 2011 to develop and commercialise micro-engineering chip-based mass spectrometry equipment. Having invested £30m over the last 20 years before and after the IPO, Microsaic has a robust patent portfolio in cutting-edge technology purpose built for "Industry 4.0" which enables analytical detection and characterisation at the point-of-need, whether within a human health environment, conventional laboratory setting, or within a bioprocessing facility for continuous mass spectrometer detection and monitoring of data at any step in the process workflow.

Microsaic's products and systems are commercially available through global markets via a network of regional and local partners, targeting its core laboratory, manufacturing, and point-of-need applications. 

About CPI (www.uk-cpi.com)

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.