Microsaic Regulatory News (MSYS)

Microsaic Systems plc

("Microsaic" or the "Company")

Launch of real-time monitoring workflows and services for scaling drug manufacture

Microsaic (AIM: MSYS) is pleased to announce the immediate roll-out of its compact Mass Spectrometry ("MS") technology integrated with autosampler and separation technology, wrapped in closed-loop (automated) control software, for use in the scale-up and operation of drug manufacturing. These monitoring solutions are targeted at contract research and manufacturing organisations ("CRMO"), integration partners and biopharmaceutical companies who manufacture vaccines, therapeutics for major diseases such as chronic autoimmune diseases.

This offering adds turn-key services to the bioprocessing industry, using compact Microsaic technology for monitoring levels of metabolites and proteins as part of wider workflows designed to:

· increase the efficiency of biotherapeutic development and manufacture;

· reduce batch failures; and,

· create the pathway to real-time data and analytics and [potential] optimisation of biopharmaceutical manufacture.

These solutions can therefore reduce manufacturing scale-up time and costs, improve quality and reduce the cost of drug manufacture, while increasing the throughput from discovery and development and the quantity of approved drugs able to reach the market in the shortest time possible.

The Company's small-footprint bio-reactor monitoring technology has already demonstrated the ability to track successfully all key parameters during biomanufacture (as announced on 2 July 2021), such as feedstocks, metabolites and now additionally the target proteins (for example, complex monoclonal antibody therapeutics) in real-time.

Glenn Tracey, CEO of Microsaic, commented: "The accelerated development and scale-up of COVID-19 vaccines has shown what can be achieved by biopharmaceutical manufacturing. It has also emphasised the need to find ways to develop and manufacture life-changing drugs and therapies on a large scale, both quickly and reliably. These new monitoring solutions bring potentially game-changing capabilities to monitor the material aspects of bioproduction, in real time and at the point of need, and to address these critical manufacturing needs. Additionally, Microsaic brings its expertise in workflow customisation, set up, and software control and analytics.

"This extension to our range of MS equipment and solutions to cover biologic molecules, alongside other gains in detection sensitivity, immediately widens the opportunities for revenues from multiple sectors in biopharmaceuticals, healthcare and environmental industries. We expect workflow service and installations to begin in H1 2022."

Background to Microsaic's Bioprocessing Solutions:

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

Biopharmaceuticals is a well-established and rapidly growing sector (valued at circa $200 billion in a 2020 report1), which faces significant challenges around process robustness. This is particularly apparent within upstream processing, which relies on fundamental biology and carries inherent product variability. Continuous 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 was 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, CRMOs 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.