Lifecore Biomedical Announces High-Speed, Multi-Purpose 5-Head Isolator Filler is GMP-Ready and Operational
19 Settembre 2024 - 1:00PM
Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully
integrated contract development and manufacturing organization
(“CDMO”), today announced that the company’s recently installed
high-speed, multi-purpose 5-head isolator filler is GMP-ready and
operational. Lifecore is now positioned to offer existing and
future customers the speed and aseptic isolation benefits of this
state-of-the-art technology for fill/finish services for prefilled
syringes, vials, and cartridges. By successfully installing and
qualifying the 5-head isolator filler, the company has more than
doubled its current capacity.
“As the industry evolves to comply with
increased controls such as the EU’s Annex 1 requirements, we are
thrilled to now have our high-speed 5-head isolator filler
GMP-ready and operational. The system enables us to offer quality
and safety enhancements to our global customers and their patients
while providing operational efficiencies in support of our
organizational growth,” said Paul Josephs, president and chief
executive officer of Lifecore. “Combined with a robust Quality
Management System, a proven regulatory track record, and unique
expertise in handling complex formulations, we believe this new
technology positions Lifecore as a leading partner for aseptic
fill/finish CDMO services.”
Lifecore believes that the addition of the
flexible 5-head isolator filler will not only improve the company’s
leadership position in the development and fill/finish of highly
viscous and complex formulations, but it will also help diversify
its customer base by supporting new projects for less viscous and
less complex protein, peptide and antibody products. Furthermore,
the new filler offers speed and quality control enhancements,
critical areas of focus for manufacturing today’s most advanced
injectable pharmaceutical and biopharmaceutical products.
“We are highly encouraged by our ongoing
conversations with both new and existing customers regarding their
interest in accessing this new capacity and capability,” said
Darren Hieber, senior vice president of corporate development and
partnerships at Lifecore. “What is particularly exciting is that we
are not only talking to companies that recognize us for our
expertise in working with challenging formulations, but we are also
having discussions with potential customers whose products
represent more straightforward production processes. We believe we
have demonstrated that Lifecore is equally adept at fulfilling the
needs of both types of companies and look forward to leveraging the
5-head filler to serve additional customers.”
About Lifecore Biomedical
Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a
fully integrated contract development and manufacturing
organization (CDMO) that offers highly differentiated capabilities
in the development, fill and finish of sterile injectable
pharmaceutical products in syringes, vials, and cartridges,
including complex formulations. As a leading manufacturer of
premium, injectable-grade hyaluronic acid, Lifecore brings more
than 40 years of expertise as a partner for global and emerging
biopharmaceutical and biotechnology companies across multiple
therapeutic categories to bring their innovations to market. For
more information about the company, visit Lifecore’s website at
www.lifecore.com.
Important Cautions Regarding
Forward-Looking Statements
This press release contains forward-looking
statements regarding future events and our future results that are
subject to the safe harbor created under the Private Securities
Litigation Reform Act of 1995 and other safe harbors under the
Securities Act of 1933 and the Securities Exchange Act of 1934.
Words such as “anticipate”, “estimate”, “expect”, “project”,
“plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can
have”, “likely” and similar expressions are used to identify
forward-looking statements. In addition, all statements regarding
our preliminary estimates of historical financial data current
operating and financial expectations anticipated capacity and
utilization, anticipated liquidity, and anticipated future customer
opportunities and relationships are forward-looking statements. All
forward-looking statements involve certain risks and uncertainties
that could cause actual results to differ materially, including
such factors among others, as the company’s ability to successfully
enact its business strategies, including with respect to
installation, capacity generation and its ability to attract demand
for its services, and its ability expand its relationship with its
existing customers or attract new customers; the impact of
inflation on the company’s business and financial condition;;
changes in business conditions and general economic conditions both
domestically and globally including rising interest rates and
fluctuation in foreign currency exchange rates; the company’s
ability to access to sufficient capital to fund its business
strategies; and other risk factors set forth from time to time in
the company’s SEC filings, including, but not limited to, the
Annual Report on Form 10-K for the year ended May 26, 2024 (the
“2024 10-K”). For additional information about factors that could
cause actual results to differ materially from those described in
the forward-looking statements, please refer to our filings with
the Securities and Exchange Commission, including the risk factors
contained in the 2024 10-K. Forward-looking statements represent
management’s current expectations as of the date hereof and are
inherently uncertain. Except as required by law, we do not
undertake any obligation to update forward-looking statements made
by us to reflect subsequent events or circumstances.
Lifecore Biomedical, Inc. Contact Information:
Vida Strategic Partners
Stephanie Diaz (Investors)
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
415-675-7402
tbrons@vidasp.com
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