Rapid Micro Biosystems Announces the Upcoming Availability of Rapid Sterility Application for the Growth Direct® System

Rhea-AI Summary

Rapid Micro Biosystems, Inc. (RPID) expects to launch the Growth Direct Rapid Sterility application by mid-year 2024. The novel, proprietary test kit developed for use with the Company’s fully automated system delivers time to organism detection in as little as 12 hours and final time-to-result in as little as one to three days. This innovation represents a significant improvement over traditional test methods, offering compelling differentiation in the market.

Insights

Biotechnology Analyst

The introduction of Rapid Micro Biosystems' Rapid Sterility application is a significant advancement in the field of pharmaceutical quality control. The ability to detect organisms in as little as 12 hours and achieve a final time-to-result in one to three days is a substantial improvement over the current 14-day incubation period required by traditional methods. This reduction in time can lead to a faster release of healthcare products to the market, which is critical in an industry where time-to-market is a key competitive advantage.

From a financial perspective, the efficiency gains and potential cost savings for pharmaceutical manufacturers could be considerable. Shorter sterility testing times may reduce inventory holding costs and enhance production throughput. Moreover, this technology could become a new industry standard, positioning Rapid Micro Biosystems as a potential market leader in sterility testing solutions, with implications for the company's revenue growth and market share expansion.

Pharmaceutical Supply Chain Expert

Streamlining the sterility testing process has far-reaching implications for the pharmaceutical supply chain. A faster time-to-result means that companies can respond more quickly to demand, improving supply chain agility. Additionally, the ability to rapidly confirm product sterility may also reduce the risk of product recalls, which can be both costly and damaging to a company's reputation.

Given the high stakes of sterility in the pharmaceutical industry, the adoption of Rapid Micro Biosystems' technology could become a critical component of risk management strategies for manufacturers. Faster detection of contamination could lead to quicker corrective actions, minimizing the impact of any potential contamination events.

Healthcare Industry Analyst

The patient safety implications of the Growth Direct Rapid Sterility application are noteworthy. Accelerating the sterility assurance process without compromising quality can lead to improved patient outcomes, as there is less chance for contaminated products to reach the market. This is particularly important for biologics and sterile injectables, which are susceptible to microbial contamination and can have serious health implications if compromised.

Furthermore, the ability to deliver faster results without sacrificing accuracy could support the healthcare industry's ongoing efforts to streamline regulatory compliance. As regulatory bodies continue to demand rigorous safety standards, innovative solutions like this one could become essential for companies striving to meet these requirements while also maintaining operational efficiency.

The new Rapid Sterility application includes a novel, proprietary test kit that has been developed for use with the Company’s fully automated Growth Direct system and delivers time to organism detection in as little as 12 hours and final time-to-result in as little as one to three days

Commercial launch of the Growth Direct Rapid Sterility application is expected by mid-year 2024

LOWELL, Mass., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, today announced that it expects the commercial launch of the Growth Direct Rapid Sterility application by mid-year 2024.

Sterility testing is the final quality check for microbial contamination before a pharmaceutical product is released for commercial sale and is typically performed in a facility that manufactures products such as biologics or sterile injectables. The Company has developed a novel, proprietary Rapid Sterility application for use with its Growth Direct system. This innovative solution delivers time to organism detection (“TTD”) in as little as 12 hours and final time-to-result (“TTR”) in as little as one to three days. This capability represents a significant improvement over widely used traditional test methods, which generally require a 14-day endpoint incubation, and provides compelling differentiation when compared to current rapid sterility products.

“We are extremely excited about the data and the results we have achieved with our new Growth Direct Rapid Sterility application – this is truly a breakthrough technology,” said Robert Spignesi, President and CEO of Rapid Micro Biosystems. “We expect Rapid Sterility to provide customers with significant advantages compared to both the traditional compendial method and other current technologies and practices being used today. The technology behind this new product aligns with our corporate mission of helping enable pharmaceutical customers to safely manufacture life-saving treatments for patients faster, and we are extremely proud of this innovation.”

The Growth Direct Rapid Sterility application leverages the Company’s platform technology, providing customers with all the benefits they are accustomed to with the Growth Direct system. These benefits include full automation, enhanced data integrity, reduced human error and lower hands-on labor costs. In addition, we expect that the Growth Direct Rapid Sterility application will enable faster release of final pharmaceutical product, allowing manufacturers to benefit from faster time to market, less potential waste and reduced inventory and holding costs.

The Growth Direct Rapid Sterility application delivers TTD in as little as 12 hours and final TTR in as little as one to three days across an expanded panel of stressed microorganisms most commonly found in biomanufacturing environments, inclusive of the U.S. Pharmacopeia (USP)<71> microorganisms. The application has been designed to meet a limit of detection of one colony forming unit (CFU) as directed by USP<1223>.

Commercial launch of the Growth Direct Rapid Sterility application is expected by mid-year 2024.

About Rapid Micro Biosystems 

Rapid Micro Biosystems is an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. The Company’s flagship Growth Direct System automates and modernizes the antiquated, manual microbial quality control (“MQC”) testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct System brings the quality control lab to the manufacturing floor, unlocking the power of MQC automation to deliver the faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. The Company is headquartered and has U.S. manufacturing in Lowell, Massachusetts, with global locations in Lexington, Massachusetts, Switzerland, Germany, and the Netherlands. For more information, please visit www.rapidmicrobio.com or follow the Company on X (formerly known as Twitter) at @rapidmicrobio or on LinkedIn.

Available Information

Rapid Micro Biosystems announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (“SEC”), press releases, public conference calls, webcasts, the investor relations section of the Company website at investors.rapidmicrobio.com, and the Company’s X (formerly known as Twitter) account @rapidmicrobio in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the expected commercial launch of the Growth Direct Rapid Sterility application by mid-year 2024; customer interest in and adoption of the Company's Growth Direct Rapid Sterility application; and the anticipated benefits of Growth Direct Rapid Sterility application for the Company’s customers.

In some cases, you can identify forward-looking statements by terminology such as “outlook,” “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements involve known and unknown risks, uncertainties and assumptions which may cause actual results to differ materially from any results expressed or implied by any forward-looking statement, including, but not limited to, the Company’s significant losses since inception; the Company’s ability to meet its publicly announced guidance and other expectations about its business and operations; the Company’s limited experience in marketing and sales and the effectiveness of its sales processes; the Company’s need to develop new products and adapt to technological changes; the Company’s ability to establish and maintain its position as a leading provider of automated microbial quality control testing; the Company’s ability to maintain its manufacturing facility; risks related to third-parties; the Company’s ability to retain key management and other employees; risks related to regulatory and intellectual property matters; risks related to supply chain disruptions and the impact of inflation; the impact of macroeconomic volatility and public health crises on the Company’s business and operations, including further delays in placements and validation of new systems; and the other important factors outlined under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on March 10, 2023, as such factors may be updated from time to time in its other filings with the SEC, which are available on the SEC's website at www.sec.gov and the Investor Relations page of its website at investors.rapidmicrobio.com. Although the Company believes that the expectations reflected in its forward-looking statements are reasonable, it cannot guarantee future results. The Company has no obligation, and does not undertake any obligation, to update or revise any forward-looking statement made in this press release to reflect changes since the date of this press release, except as may be required by law.

FAQ

What is the expected commercial launch date for Rapid Micro Biosystems, Inc.'s (RPID) Growth Direct Rapid Sterility application?

The commercial launch is expected by mid-year 2024.

What is the purpose of the novel, proprietary test kit developed by Rapid Micro Biosystems, Inc. (RPID)?

The test kit is developed for use with the Company’s fully automated Growth Direct system and delivers time to organism detection in as little as 12 hours and final time-to-result in as little as one to three days.

How does the Rapid Sterility application by Rapid Micro Biosystems, Inc. (RPID) compare to traditional test methods?

The Rapid Sterility application offers a significant improvement over traditional methods by providing faster time to organism detection and final time-to-result, as well as compelling differentiation in the market.

What is the significance of sterility testing in pharmaceutical product manufacturing?

Sterility testing is the final quality check for microbial contamination before a pharmaceutical product is released for commercial sale, typically performed in facilities that manufacture biologics or sterile injectables.

What are the benefits of the Rapid Sterility application developed by Rapid Micro Biosystems, Inc. (RPID)?

The application offers faster time to organism detection and final time-to-result, as well as compelling differentiation in the market, compared to current rapid sterility products.