CordenPharma has announced a major capital expenditure initiative to further enhance its lipid purification capacity in CordenPharma Colorado. The expansion includes additional production lines, which are aimed to be incorporated into the lipid manufacturing process by April 2021. The investment will significantly increase the company’s lipid shipment delivery time by the end of July 2021, it says.
As of early 2021, there are eight ongoing human trials for mRNA vaccines led by Moderna, BioNTech / Pfizer, CureVac, Sanofi / TranslateBio, Arcturus / Duke-NUS Medical School (Singapore), Imperial College London, Chulalongkorn University in Thailand, and Providence Therapeutics.
Owing to increasing demand since the beginning of the pandemic for mRNA COVID-19 vaccines formulated with Lipid NanoParticle (LNP) delivery systems, CordenPharma has been continuously investing in expanded lipid supply chain at its facilities in Switzerland, France, and Colorado.
CordenPharma manufactures four lipids that are typically used to formulate LNPs for various synthetic mRNA-based vaccines, including cationic lipids, which encapsulate the negatively charged mRNA and PEGylated lipids that help to form a protective hydrophilic layer which sterically stabilises the LNP. It also manufactures DiStearoylphosPhatidylCholine and plant-based cholesterol.
LNP delivery systems not only efficiently express the mRNA-encoded immunogen after intramuscular injection, but also play a role as adjuvants in vaccine reactogenicity. All four lipid components of an LNP delivery system require very high purity, the company says.
CEO & President Dr Michael Quirmbach said: “CordenPharma is proud to contribute this major capital expansion to increase important lipid production for the global market. We have drawn upon longstanding expertise in specialised lipids to create an even stronger integrated network of facilities to support current and future projects.”