Rapid Micro Biosystems® Announces Publication of a Multi-Author Case Study Supporting Fully Automated Colony Counting in Pharmaceutical Microbiology
December 07 2022 - 4:30PM
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.
Investor Contact:
Michael Beaulieu, CFA
Vice President, Investor Relations and Corporate Communications
investors@rapidmicrobio.com
Media Contact:
media@rapidmicrobio.com
Rapid Micro Biosystems (NASDAQ:RPID)
Historical Stock Chart
From Jun 2024 to Jul 2024
Rapid Micro Biosystems (NASDAQ:RPID)
Historical Stock Chart
From Jul 2023 to Jul 2024