Cost and time savings in manufacture of biologics

3 June 2019

Microsaic Systems plc

("Microsaic" or the "Company")

Microsaic's technology breakthrough demonstrates cost and time savings in the manufacture of biologics

Microsaic Systems plc (AIM: MSYS), the developer of point of need mass spectrometry ("MS") instruments, has developed proof of concept workflows to analyse in real-time complex samples from bioreactors, which could enable customers to achieve significant costs and time savings.

An independent laboratory was engaged to compare the use of Microsaic's MiD® ProteinID technology as an in-situ technique for measuring small and large molecules during the manufacture of biologics compared with the use of traditionally accepted bioanalysers. The results were obtained by quantifying small-molecule cell media as well as measuring intact proteins. Microsaic's MS technology detected metabolites not usually seen by traditional methods during the bio-manufacturing process.

The results will be presented at the American Association of Mass Spectrometry Week on 3 June 2019, in Atlanta, US. A copy of the results is available on the Microsaic website at www.microsaic.com/resources/application-notes/.

From the information obtained, Microsaic estimates that there are potentially substantial savings available for its customers by switching from traditional analysis methods to Microsaic's MiD® ProteinID technology.

On 5 March 2019, Microsaic published early results with the Massachusetts Institute of Technology (MIT) which demonstrated the real-time analysis of complex protein feedstocks: the results highlighted the importance of storage conditions between fresh fed batch and frozen perfusion samples to beneficial biologic manufacture outcomes.

Glenn Tracey, CEO of Microsaic, commented: "These latest results are extremely exciting for the Company and mark yet another important milestone in the strategy set out when I took on the role of CEO.

What we have demonstrated is the potential for our technology to replace very expensive analysers, which have been the mainstay of bio-analysis over time. As our technology can measure small and large molecules simultaneously, we can potentially replace workflows which use several analysis techniques costing hundreds of thousands of pounds each in capital expenditure. Additionally, because our technology is 'label-free' (scientists do not need to tag their molecules of interest with dyes such that the current technology can identify them), Microsaic can potentially save hours of workflow time and provide a significant saving in reagent costs.

New demands on bioprocessing mean that there is a requirement for real-time information at the point of need. Microsaic's deployable MS technology samples the media from a bioreactor in real-time, providing critical information regarding process monitoring and quality attributes of the end-product. This information can then be used to maximise yields of biologics by optimising the cell media, cell feeding and harvesting strategies of the target biologic product. As a result of our technology being able to measure small and large molecules, we can further analyse those process changes for cell media, feedstocks and end-product biologics.

In addition, MS point of need analysis would provide timely safety assurance, as harmful post-translation modifications of the product, and other dangerous host cell proteins, can potentially be controlled and minimised upstream."

Notes for Editors:

The monitoring of small molecules in cell culture media and intact protein is possible with the Microsaic MiD® ProteinID mass spectrometer based on miniaturized chip-based technology with an adjustable mass range between 50 and 3200 m/z. The MS features a miniaturized quadrupole mass filter and microflow electrospray source. The resulting small footprint (55 x 35 x 25 cm), low maintenance and ease of use allows it to be easily used at-line and at the point of need.

Recently, Microsaic announced at its AGM that orders for its MS technology were significantly above the whole of the first half of 2018.

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About Microsaic Systems

Microsaic Systems plc (AIM: MSYS) is a high technology company developing chip-based, bench-top and point-of-analysis mass spectrometry ("MS") instruments that are designed to improve the efficiency of pharmaceutical R&D and manufacturing. The Company is working with established global life science companies to co-develop new solutions to improve productivity in the development of small molecule and novel biologic (peptides, antibodies) medicines. MS is a powerful method of analysis to enable earlier decision making relating to product identification, purity and bioactivity, and is the analytical technique of choice for biochemists across many industry sectors.

Microsaic's products retain the functionality of larger conventional MS systems, but are deployable for use at the point of need, easier to use by non-specialists, consume less energy and have lower running costs. For more information, please go to www.microsaic.com.