- Proceeds will 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.
- Global investor syndicate is led by
Ally Bridge Group, joined by Endeavour Vision, and existing investors including Bain Capital Life Sciences, Longitude Capital, Xeraya Capitaland Asahi Kasei Medical.
- COVID-19 pandemic highlights the ability of the Growth Direct™ platform to shorten the supply chain for critical drugs and vaccines while also allowing biopharmaceutical companies to operate their manufacturing facilities with reduced staff.
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A quality control specialist loads multiple sample cartridges into the Rapid Micro Biosystems Growth Direct instrument for automated, high-throughput microbial contaminant testing. (Photo: Business Wire)
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.1 With current trends,
“We are very pleased to have such strong support from this global investor group as we expand the adoption of our industry-leading solutions for automated microbial contaminant detection in manufacturing facilities of biopharmaceutical companies around the world,” said
“Rapid Micro Biosystems has established a robust customer base in the
Advanced high-throughput quality control technology enables faster, safer manufacturing for drugs, vaccines and complex new therapies
Global biopharmaceutical companies increasingly recognize that advanced drug manufacturing requires state-of-the-art quality control (QC) technology to enable greater speed and efficiency, while ensuring safety and data integrity. 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 Growth Direct 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.
- Biologics and sterile injectables require robust and stringent QC, including automated microbial contaminant testing, to ensure uptime and drug supply to patients.
- Processes for cell and gene therapies have unique complexities. These include CAR-T therapies that require rapid turnaround times from sample collection to patient infusion; Growth Direct is currently used in manufacturing facilities for commercially available cell therapy products approved by the
- Time-sensitive demands, such as vaccine manufacturing in response to pandemics and seasonal outbreaks, are well-suited to high-throughput and automated QC to support dramatic increases in bioprocessing speed and capacity.
“Rapid Micro Biosystems offers a fully automated microbial testing solution to replace existing resource intensive and time-consuming processes. The company’s expanding client base, anchored by top-tier biopharma customers, highlights the significant impact its technology is having on the fast, efficient and safe manufacture of medicines to meet growing global demand,” said
Funding to drive commercial expansion and global manufacturing of Growth Direct platform, including new product development for pandemic response
This new round of financing will support the next stage of commercial growth for
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
“State-of-the-art technologies are necessary for manufacturing to keep pace with innovative drugs and the demand for speed and capacity in the biopharmaceutical industry, while protecting product quality and data integrity. The ongoing global health threat posed by infectious diseases, such as COVID-19, only serve to intensify the need for investing in advanced technologies, such as those provided by Rapid Micro Biosystems,” said
“With this financing,
1 Jimenez, L., Analysis of FDA Enforcement Reports (2012-2019) to Determine the Microbial Diversity of Contaminated Non-Sterile and Sterile Drugs, American Pharmaceutical Review,
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