Rapid Micro Biosystems Inc. scooped up $120 million in a series C financing led by Ally Bridge Group, with participation by Endeavor Vision and existing investors Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei. The Lowell, Mass.-based company has earmarked the funds to expand the global footprint of its contaminant testing platform for biopharmaceutical and vaccine manufacturing and for new product development.

The shot in the arm comes as Rapid Micro Biosystems has been experiencing “very, very strong growth … about 100%” and stands to play an expanded role in the COVID-19 pandemic, CEO Robert Spignesi said.

Manufacturing of complex products such as biologics, sterile injectables, cell therapies and vaccines requires highly skilled individuals and high levels of quality assurance. This includes tests for quality control to ensure drug products are free from microbial contamination, which can impact product integrity and lead to delays, product recalls and possible drug shortages. Between 2012 and 2019, the number of drug and raw materials recalls linked to microbial contamination increased nearly fivefold, compared with the prior seven-year period, along with a threefold rise in the diversity of microbes identified as contaminants.

Automating the process

Today, the majority of testing for microbial contaminants in biopharmaceutical manufacturing is done manually, from the collection of samples to placing them in incubators and checking over the ensuing days for any kind of growth. It’s a repetitive, error-prone process, which can be subject to falsification. It’s also slow: Depending on the kind of test being performed, results typically take from five to 14 days.

Rapid Micro Biosystems’ microbial detection platform, Growth Direct, is designed to improve this part of the manufacturing cycle by automating and accelerating the microbial quality control process.

The product combines capital equipment and consumables, in the form of sample collection devices, with robotics and computer systems to churn out results in half the time of standard test methods, according to the company. Quality control teams can handle the majority of standard microbial detection tests with minimal human interaction and remote monitoring, an added benefit for teams that may be working with reduced staff due to the pandemic.

“We have created a fully automated system that incubates, analyzes and automatically records all the test information in a very secure paperless way that accelerates the results and provides information to customers to make decisions sooner,” Robert Spignesi told BioWorld. In many cases, that’s to ship to market sooner or, if they have a challenge in the manufacturing process, to remedy it sooner.”

He noted that in many cases, companies can get results in as little as 16 to 24 hours.

The company counts as customers a majority of the top 20 biopharmaceutical manufacturers as well as some small and mid-size companies. Revenue – which Spignesi pegged at “under $100 million” – is split evenly at about 45% in North America and Europe, with the remainder in Asia, where Growth Direct sales have been growing rapidly.

“Rapid Micro Biosystems has established a robust customer base in the U.S., Europe and Asia-Pacific region, owing to the clear advantages offered by its platform and services for all types of biopharmaceuticals,” said Frank Yu, founder, CEO and CIO of Ally Bridge Group. “We expect to see strong adoption of the company’s products as increasing numbers of biopharmaceutical companies seek to take advantage of leading-edge technologies to support manufacturing speed and capacity improvements, as well as ensuring quality to satisfy increasingly stringent regulatory requirements.”

Use of proceeds

The company plans to use the series C proceeds to intensify its efforts in three main areas, the first being expanded commercial capability. To that end, it will be adding new hires in sales and marketing, as well as services. “We’re growing headcount at about 20% to 30% a year right now,” Spignesi said, noting the company currently has 130 employees.

Another part of the proceeds will go toward increasing and expanding the company’s global manufacturing and supply chain networks. “We continue to add customers at increasing rates of volumes – both systems and consumables – and making sure we have the right end products and in the right regions at the right times” is key, he added.

A final chunk of funds will fuel product innovations that enhance the speed, efficacy and capacity of microbial quality control testing.

To that end, Rapid Micro Biosystems is eyeing a late 2020 or 2021 release of a rapid sterility consumable test to be used in conjunction with the Growth Direct system. The test was developed in partnership with HHS’ Biomedical Advanced Research and Development Authority, under BARDA’s pandemic response for influenza.

Spignesi said that In the event of a flu pandemic, the test can cut the release time for vaccines to five to seven days, from the standard 14 days, dramatically accelerating availability in the market. While the assay was developed with influenza vaccines in mind, it can be used in any product requiring a sterile release, he added.

Value prop in the COVID-19 era

As vaccines and potential therapies begin to emerge, global supply chains will be challenged with the number of doses that have to be manufactured and pressures to get products to market quickly.

“Pre-pandemic, we were experiencing very, very strong growth driven by the uptake of biologics and cell and gene therapies, which requires speed and accuracy and very high-end type of products,” Spignesi said. “The COVID-19 pandemic we’re living through has shown a spotlight on our value proposition.”

Particularly at this time, he stressed, speed to market is important. “If you’re making fewer mistakes and accelerating the [quality control] process, you’ve freed up capacity and shortened the supply chain, which is going to be incredibly important with regard to COVID-19 vaccine and therapy manufacturing.”

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