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Croda Pharma Expands Lipid Systems Capability to Support mRNA Vaccines

Will establish a new lipid facility as part of a multi-purpose cGMP site in Pennsylvania.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Croda International has entered into an agreement with the U.S. government in which the government will provide up to $75 million to expand the company’s U.S. manufacturing capacity of ingredients for lipid systems used in novel therapeutic drugs, such as mRNA vaccines.

In line with the company’s strategy to “Empower biologics delivery,” Croda will also invest up to $58 million, bringing the total project investment to up to $133 million. The investment will be used to establish a new lipid facility as part of a new multi-purpose cGMP site in Lamar, Pennsylvania.

Construction is expected to start later this year, with the new capacity anticipated in 2025. The investment supports expansion of the portfolio of drug delivery solutions offered by Croda, by creating a third manufacturing site for lipid systems, alongside Croda’s existing Alabaster, AL, and Leek, UK, capabilities.

Croda’s pharma business is a leading partner in the development of delivery systems for biologics. Croda’s platforms enable the next generation of vaccines and therapeutics. Through acquisition of Avanti Polar Lipids in 2020, Croda was the first company to supply clinical and commercial quantities of critical lipid systems to support the roll-out of COVID-19 vaccines globally.

Lipid systems offer significant potential as the delivery system for a wide range of nucleic acid applications, including novel mRNA-based therapeutics, such as flu vaccines and cancer treatments. Given the scale of the current clinical development pipeline, the market for lipid systems is expected to grow significantly over the next ten years.

“We are grateful to the U.S. government for support of Croda,” said Daniele Piergentili, president of Croda Life Sciences. “The delivery technology based on lipid systems offers significant potential for the safe and efficient delivery of next generation vaccines and therapeutic drugs. As a result of this investment, Croda will be able to expand its capabilities to develop and manufacture ingredients in support of this important technology.”

The cooperative agreement is a joint award from the Biomedical Advanced Research and Development Authority (BARDA), part of Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services and the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in partnership with the Army Contracting Command’s Joint COVID Response Division (ACC JCRD).

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