The investment will be used to establish a new lipid facility as part of a new multi-purpose cGMP site in Lamar, Pennsylvania. The developer will also invest up to US$58m in the project.
Construction on the Lamar site is expected to start later this year.
This will be Croda’s third manufacturing facility for lipid systems, alongside its existing Alabaster, Alabama, US and Leek, UK capabilities. The additional US capacity for those raw materials is anticipated in 2025.
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 US Department of Health and Human Services and the US 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).
Lipid-based drug delivery systems carry nucleic acid material, protecting this genetic material from degradation, while also allowing it to access the cell and, once inside, be released, thus allows the cellular machinery to translate the delivered genetic material into a cellular response.
Meeting rising market demand
Given the scale of the current clinical development pipeline, Croda expects the market for lipid systems to grow significantly over the next ten years. “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.”
Croda acquired Avanti Polar Lipids in 2020, a pioneer in terms of the development of liposomal-based drug delivery systems aimed at overcoming stability and delivery issues associated with mRNA-based vaccines and therapeutics. That deal enabled Croda to be the first company to supply clinical and commercial quantities of lipid systems to support the roll-out of COVID-19 vaccines globally.
Focused on supporting biologics drug delivery, Croda has adjuvant systems, small molecule, protein, and nucleic acid delivery platforms in its portfolio.