Rapid Micro Biosystems Expands Testing Platform
By Contract Pharma Staff | 05.22.20
Raises $120 million to accelerate global expansion of contaminant testing platform for pharmaceutical and vaccine manufacturing
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.
With current trends, Rapid Micro Biosystems says it 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 maximize capacity to meet growing global demand.
“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 Robert Spignesi, chief executive officer, Rapid Micro Biosystems. “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 modernize their manufacturing operations, improve their processes and make faster decisions.”
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. According to the company, 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 U.S. 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.
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 U.S. 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,” said Jeff Schwartz, managing director, Bain Capital Life Sciences. “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.”