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USA: Vaccine Manufacturing Rapid Micro Biosystems to Accelerate Global Expansion of Microbial Testing Platform

Editor: MA Alexander Stark

Due to Covid-19, global demand for drugs and vaccines is growing rapidly. In response, manufacturers of biologics, sterile injectables, vaccines and cell and gene therapies are increasingly turning to the Growth Direct platform offered by Rapid Micro Systems.

A quality control specialist loads multiple sample cartridges into the Rapid Micro Biosystems Growth Direct instrument for automated, high-throughput microbial contaminant testing.
A quality control specialist loads multiple sample cartridges into the Rapid Micro Biosystems Growth Direct instrument for automated, high-throughput microbial contaminant testing.
(Source: Matthew McKee/ Business Wire)

Lowell/USA — The provider of fully automated, high-throughput, rapid microbial detection technology for biopharmaceutical manufacturing Rapid Micro Systems announced the completion of a $ 120 million financing. The proceeds are to enable the company to meet growing demand for its automated microbial detection platform, currently used by a majority of the top 20 global biopharmaceutical companies, and support new product development for pandemic response.

With the increasing number and complexity of drug products – including biologics, sterile injectables, cell therapies and vaccines – manufacturing processes are more susceptible to the impact of microbial contamination, such as bacteria, mold and fungi. These events can lead to variability of the drug product and lengthy investigations requiring shutdown of operations and product recalls and potentially leading to drug shortages. There were nearly five times more recalls of drug products and raw materials due to microbial contamination during 2012-2019 than in the previous seven year period, along with a three-fold increase in the diversity of microbes identified as contaminants. With current trends, Rapid Micro Biosystems has seen growing adoption of its fully-automated microbial detection platform, Growth Direct, by leading biopharmaceutical companies to accelerate drug and vaccine production, meet stringent quality requirements, and maximize capacity to meet growing global demand.

A majority of the top 20 industry players have already adopted Growth Direct, and the company has seen accelerating global demand for its system as regulators push for more stringent quality and traceability, and as volumes of high-value drug production increase.

The company’s platform automates the majority of standard microbial QC tests, replacing the time- and labor-intensive manual QC processes and delivering results in half the time. Fully automated microbial contaminant testing can be performed with minimal human handling and remote system monitoring and data reporting capabilities to ensure manufacturing continuity at a time when QC labs must remain fully operational, despite reduced staff due to Covid-19 restrictions.

The ability to compress timelines and ensure sterility is particularly suited to bioprocessing for state-of the-art manufacturing and for complex new therapeutic modalities, as well as ensuring the delivery of safe medicines for patients.

This new round of financing is to support the next stage of commercial growth for Rapid Micro Biosystems and includes senior debt financing from Kennedy Lewis Investment Management, in addition to equity capital. The proceeds will fund further commercial expansion in the United States, Europe and Asia, and support investments in global supply chain and manufacturing capability.

In addition, the financing will accelerate new product development, including a rapid sterility test for the final release of products which can significantly shorten the supply chain by accelerating deployment of biologics, vaccines and cell therapies to patients. Development of the rapid sterility test has been advanced through a partnership with the U.S. Biomedical Advanced Research and Development Authority (Barda) for responsiveness to pandemic threats.

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