Rapid Micro Biosystems® Announces Publication of a Multi-Author Case Study Supporting Fully Automated Colony Counting in Pharmaceutical Microbiology
Rapid Micro Biosystems (Nasdaq: RPID) has announced the publication of a case study in the PDA Journal of Pharmaceutical Science and Technology, validating its automated colony counting technology for pharmaceutical microbiology. The research showcases the effectiveness of the Growth Direct system in enhancing quality control with faster results and improved accuracy. Conducted by eight global pharmaceutical firms, the study confirms compliance with regulatory standards. The Growth Direct system is already in routine use for multiple QC tests, supporting safe healthcare product releases.
- Publication of a validating case study enhances credibility.
- Demonstrated effectiveness of Growth Direct system in quality control.
- Techniques adopted are compliant with regulatory standards.
- Increased operational efficiency reported from automation.
- None.
LOWELL, Mass., Dec. 07, 2022 (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, announced the publication of a Multi-Author Case Study Supporting Fully Automated Colony Counting in Pharmaceutical Microbiology.
This study, published online by the PDA Journal of Pharmaceutical Science and Technology, sought to evaluate colony counters as an automated compendial microbiological test method and references current regulatory guidelines. In order to simplify validation, all sites followed a modular validation approach that had been developed by the participants. The modular validation facilitates the efficient implementation of the technology to routine use while complying with regulatory requirements.
“The results of the study demonstrate that automation technology, such as the Growth Direct system, used to incubate, enumerate, and detect organisms, can meet the challenges in pharmaceutical quality control including faster time to result, accuracy, and enhanced data integrity,” said Rob Spignesi, President and CEO of Rapid Micro Biosystems. “The study data conveyed consistent performance of the technology between all sites, which is an important consideration for regulators and large customers with global manufacturing sites.”
This publication was produced by eight global pharmaceutical companies who implemented and validated an automated colony counting technology to perform quality control microbiology tests, environmental monitoring, bioburden and water testing, in-process product samples and bulk drug substance bioburden. The Growth Direct system has been successfully implemented for routine use in cGMP areas for all applications and QC test requirements mentioned, as well as in-process bioburden testing for new drug applications to the FDA and EMA.
The study can be accessed through this link: Access Full Publication.
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 in-line/at-the-line MQC automation to deliver 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 Twitter or LinkedIn.
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 Company’s interpretation of the results of the study; the Growth Direct system’s effectiveness in pharmaceutical quality control; and ongoing successful implementation of the Growth Direct system at customers’ manufacturing sites.
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 impact of macroeconomic volatility and COVID-19 and its variants on the Company’s business and operations, including further delays in placements and validation of new systems; the Company’s significant losses since inception; the Company’s ability to meet its publicly announced guidance and other expectations about its business and operating results; 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; its 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; risks relation to the exploration of strategic alternatives; and the other important factors outlined under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, 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 significance of the case study published by Rapid Micro Biosystems?
How does the Growth Direct system impact pharmaceutical manufacturing?
Which companies participated in the case study related to Rapid Micro Biosystems?
What are the reported benefits of using the Growth Direct system?
When was the case study about Rapid Micro Biosystems published?
