Rapid Micro Biosystems, a provider of fully automated, high-throughput, rapid microbial detection technology for biopharmaceutical manufacturing, has announced the completion of a $120 million financing.
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, mould 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 maximise capacity to meet growing global demand.
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
Robert Spignesi, CEO of Rapid Micro Biosystems, said: "Global demand for drugs and vaccines is growing rapidly, a trend further amplified by the current pandemic. In response, manufacturers of biologics, sterile injectables, vaccines and cell and gene therapies are turning to the Growth Direct platform to modernise their manufacturing operations, improve their processes and make faster decisions."
"Rapid Micro Biosystems has established a robust customer base in the US, 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, of the investors. "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."
Global biopharmaceutical companies increasingly recognise 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 labour-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 US FDA.
- 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 Alexander Schmitz, Partner at Endeavour Vision, who joined the company's board as part of the financing.
This new round of financing will 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 US, 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 US Biomedical Advanced Research and Development Authority (BARDA) for responsiveness to pandemic threats.
"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 Jeff Schwartz, Managing Director, Bain Capital Life Sciences.
"With this financing, Rapid Micro Biosystems will cement its role as a key player in the global pharmaceutical supply chain, deploying the Growth Direct platform across the globe in facilities making products used by millions of patients every year," said David Hirsch, Managing Director of Longitude Capital.