To meet the high demand for lipids, MilliporeSigma has launched its high-purity synthetic cholesterol product nine months early. 

“By launching our new SAFC synthetic cholesterol product nine months early, we are able to meet the high demand for lipids that we’re seeing due to the COVID-19 pandemic, as lipids are a key component of mRNA-based vaccines and therapeutics,” Matthias Bucerius, head of Actives & Formulation at MilliporeSigma told us.  

The early launch of its cholesterol product has increased its capacity by 50 times.  

According to the contract development manufacturing organization (CDMO), it is one of the few firms that can produce lipids in quantities to meet the demand for mRNA therapeutics, including supporting Pfizer/BioNTech’s COVID-19 vaccine Comirnaty (BNT162b2). 

The firm attributed the launch of its product to the acquisition of German CDMO AmpTec and its polymerase chain reaction (PCR)-based technology, which saw MilliporeSigma bolster its mRNA manufacturing offering in January.  

Image: iStock/ thitimon toyai

Bucerius told BioProcess Insider the acquisition also “expanded our team […] which further strengthened our mRNA capabilities.” 

Global presence  

MilliporeSigma manufactures lipids globally. This includes Darmstadt, Germany, Schaffhausen, Switzerland, Arklow, Ireland and Missouri, USA.  

“Lipids are manufactured through multi-step organic synthesis,” said Bucerius. 

“Lipids are critical to the drug delivery system of mRNA therapies or vaccine to the body to be effective, and lipid nanoparticles (LNPs) provide a safe and effective drug delivery system to target COVID-19 and other diseases.”  

He added: “We are able to produce custom lipids in significant quantities and according to the highest quality requirements needed for vaccine production.”  

MilliporeSigma declined to disclose details of individual customers and the volume of lipids they require.