While vaccines will soon need to be developed and manufactured at pandemic speed, they also have to be standardized, sterile and safe to ensure efficacy and quality.
Lowell-based Rapid Micro Biosystems, a startup that handles microbial contaminant testing for biopharmaceutical manufacturing, has raised $120 million in new funding to do just that. The round was led by Ally Bridge Group and Endeavour Vision, with participation from existing investors Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei Medical.
The funding will accelerate the development of Growth Direct, the company's fully automated microbial detection platform to ensure vaccines, drugs and other novel therapeutics are sterile, safe and free of microbial contamination.
Microbial quality control is a process to check for bacteria, mold and fungi growth in drugs, sterile injectables, cell therapies and vaccines. Poor or subpar testing can lead to variability of the drug, thereby requiring recalls, which could potentially lead to shortages during a pandemic.
"The financing started pre-Covid when we saw our business growing," said CEO Robert Spignesi. "But Covid really added a spotlight on our value proposition."
Rapid Micro Biosystems' technology, the company says, automates an otherwise labor-intensive process. Its flagship product, Growth Direct, is a machine about the size of a large fridge. The samples collected go into the system to undergo a test protocol. Here, the machine's vision system can detect and analyze growth in half the time it would otherwise take. For instance, a 14-day sterility test could take anywhere between five and seven days, according to Spignesi.
“Global demand for drugs and vaccines is growing rapidly, a trend further amplified by the current pandemic," Spignesi said in a statement. "In response, manufacturers of biologics, sterile injectables, vaccines and cell and gene therapies are turning to the Growth Direct platform to modernize their manufacturing operations, improve their processes and make faster decisions.”
The company has also partnered with U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority to develop a rapid sterility application to focus on the influenza pandemic, aiming for an end-of-year launch.
Proceeds from this round will also fund the 20-year-old company's further expansion in the United States, Europe and Asia, allowing Rapid Micro Biosystems to hire sales and service personnel and new product development.
