Installation and Qualification Successfully Completed for Closed-System Filler for Pre-Filled Syringes, Vials, and Cartridges
Offers State-of-the-Art Speed and Aseptic Isolation Required for Fill/Finish of Latest Sterile Injectable Pharmaceutical and Biopharmaceutical Products
Current Capacity More than Doubles with New Filler
CHASKA, Minn., Sept. 19, 2024 (GLOBE NEWSWIRE) — 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.
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