WALTHAM, Mass., Oct. 19 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported that it has completed the final phase of
expansion of its manufacturing facility with increased capabilities and
capacity. The construction of this multi-thousand liter E. coli
fermentation suite enables the complete manufacture of recombinant
biologics, such as recombinant Protein A, including fermentation, recovery,
purification, packaging, quality control and quality assurance at our
facility in Waltham, Massachusetts. Previously this year, we completed the
construction of a third large-scale purification suite, which allows us to
increase our manufacturing throughput in excess of 200 kilograms of
recombinant protein each year.
"The creation of this facility has been in response to the potential
for continued growth of the monoclonal antibody market, which in turn
drives demand for our Protein A products," stated Walter C. Herlihy,
President and Chief Executive Officer of Repligen Corporation. "We believe
that we will be able to meet market demand for Protein A for the next
several years without the need for significant additional capital
expenditure. The addition of fermentation to our manufacturing capabilities
will decrease our reliance on external contractors and increase our ability
to maintain supply chain security for our customers in an increasingly risk
averse environment."
Repligen has supported the manufacture of its products through Drug
Master Files with the Food and Drug Administration for more than 20 years
and we have a formal system and commitment to continued Business Continuity
Planning. Repligen is the world's leading supplier of recombinant Protein
A, a consumable used in the manufacture of therapeutic monoclonal
antibodies, the fastest growing segment of the biotechnology market.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the
development of novel therapeutics for diseases that affect the central
nervous system. In addition, we currently market two commercial products,
Protein A and SecreFlo(R), which partially fund the advancement of our
development pipeline while supporting our financial stability. Repligen's
corporate headquarters are located at 41 Seyon Street, Building #1, Suite
100, Waltham, MA 02453. Additional information may be requested from
http://www.repligen.com.
This press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. The forward-looking statements in this release do not
constitute guarantees of future performance. Investors are cautioned that
statements in this press release which are not strictly historical
statements, including, without limitation, statements regarding current or
future financial performance and position, management's strategy, plans and
objectives for future operations, plans and objectives for product
development, plans and objectives for present and future clinical trials
and results of such trials, plans and objectives for regulatory approval,
litigation, intellectual property, product development, manufacturing plans
and performance such as the anticipated growth in the monoclonal antibody
market and our other target markets and projected growth in product sales,
constitute forward-looking statements. Such forward-looking statements are
subject to a number of risks and uncertainties that could cause actual
results to differ materially from those anticipated, including, without
limitation, risks associated with: the success of current and future
collaborative relationships, the market acceptance of our products, our
ability to compete with larger, better financed pharmaceutical and
biotechnology companies, new approaches to the treatment of our targeted
diseases, our expectation of incurring continued losses, our uncertainty of
product revenues and profits, our ability to generate future revenues, our
ability to raise additional capital to continue our drug development
programs, the success of our clinical trials, our ability to develop and
commercialize products, our ability to obtain required regulatory
approvals, our compliance with all Food and Drug Administration
regulations, our ability to obtain, maintain and protect intellectual
property rights for our products, the risk of litigation regarding our
intellectual property rights, our limited sales and manufacturing
capabilities, our dependence on third-party manufacturers and value added
resellers, our ability to hire and retain skilled personnel, our volatile
stock price, and other risks detailed in Repligen's filings with the
Securities and Exchange Commission. Repligen assumes no obligation to
update any forward-looking information contained in this press release or
with respect to the announcements described herein.
SOURCE Repligen Corporation
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Related links:
http://www.repligen.com
CONTACT:
Walter C. Herlihy, Ph.D., President and Chief
Executive Officer, +1-781-419-1900, or Laura Whitehouse, Vice
President, Market Development, +1-781-419-1812, both of Repligen
Corporation
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