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May 21, 2020updated 20 May 2020 11:43am

Rapid Micro Biosystems raises $120m: improving contamination testing in pharma

Rapid Micro Biosystems has raised $120m in a funding round to support further expansion and uptake of its automated, rapid microbial detection technology for manufacturing, Growth Direct. What role has the Covid-19 played in highlighting the need for rapid and quality controlled microbial contamination testing?

By Allie Nawrat

Massachusetts-based Rapid Micro Biosystems has closed a $120m financing round, led by the new investors Ally Bridge Group and Endeavour Vision. Existing investors, including  Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei Medical, also participated in the funding round.

Rapid Micro Biosystems is a crucial player behind the scenes of the pharmaceutical industry; the company provides automated, high-throughput microbial detection technology for manufacturing through its Growth Direct platform.

The company plans to use this $120m of funding to accelerate the global expansion of this technology to meet growing demand, particularly in the context of Covid-19 and its disruption of pharma manufacturing.

Importance of effective microbial contamination testing

“Microbial contamination events can lead to patient safety issues, variability of the drug product, warning letters from regulatory authorities, lengthy investigations requiring shutdown of operations and possible product recalls,” explains Rapid Micro Biosystems CEO Robert Spignesi. “In-process contamination is a problem that has been on the rise, particularly with the growing number of complex drug modalities, including biologics, cell and gene therapies, sterile injectables and vaccines.”

The problem is that “traditional [quality control] QC methods are slow, error-prone, highly manual legacy processes that have lagged behind other manufacturing upgrades in the biopharmaceutical industry”, meaning the industry was seeking modern alternatives: enter Growth Direct.

“Our Growth Direct platform is the first and only platform to fully automate the majority of standard microbial QC tests and replaces the time- and labour-intensive manual approach of traditional QC processes,” notes Spignesi.

As a result of its efficiency compared to traditional methods, Growth Direct has been in demand; the majority of the top 20 pharma industry manufacturers are using the product. This is why Rapid Micro Biosystems needed this $120m of funding to respond to the global demand for Growth Direct and particularly to ”fund our ongoing commercial expansion in the United States, Europe and Asia” as well as “support investments in global supply chain and manufacturing capacity”, explains Spignesi.

Spignesi adds: “In addition, the financing will be used to accelerate new product development, including a rapid sterility testing product for the final release of products which can significantly shorten the supply chain by accelerating deployment of biologics, vaccines and cell therapies to patients.”

This product has been developed through a multi-year partnership with the US Government’s Biomedical Advanced Research and Development Authority (BARDA).

Covid-19 and pharma manufacturing

Pharma’s supply chains have been hit hard by the Covid-19 pandemic. The situation has pushed pharma companies to rethink their manufacturing approaches to meet demand. “Drug and vaccine manufacturers are accelerating the speed of manufacturing to unprecedented levels and expanding capacity,”, says Spignesi.

However, Spignesi notes that the shift towards shorter batch release manufacturing at speed and scale was already underway before the pandemic. Covid-19 simply pushed “the biopharmaceutical industry to accelerate their decision making” to modernise QC manufacturing strategies, to the benefit of Rapid Micro Biosystems.

“The presence of Covid-19 only amplifies our business opportunities,” Spignesi concludes.  “Our investors were compelled by our business before Covid-19, and they are even more excited about our prospects now.”

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