MilliporeSigma accelerates scale up of lipids to meet COVID-19 demand

Filling of MilliporeSigma’s new synthetic cholesterol product at the company’s Darmstadt, Germany facility. This new product is more than 99 percent pure, offers high batch-to-batch consistency and is scalable under commercial GMP.

BURLINGTON, Mass. — To meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics, MilliporeSigma has launched a new synthetic cholesterol product, nine months ahead of schedule.

“Tapping into two decades’ experience of developing and manufacturing high-quality lipids, we designed a proprietary process to bring our new SAFC synthetic cholesterol product to market nearly a year early,” said Andrew Bulpin, head of Process Solutions at MilliporeSigma in a prepared statement. “With the introduction of our new SAFC® synthetic cholesterol product, we have increased our capacity by 50 times, helping biomanufacturers bring lifesaving therapies to patients faster.”

MilliporeSigma manufactures lipids in Schaffhausen, Switzerland; Darmstadt, Germany; and St. Louis, Missouri, USA. While there are animal-derived and synthetic versions of cholesterol available on the market, MilliporeSigma’s synthetic cholesterol product offers high purity, scalability, and consistent quality.

This neutral lipid, used in commercially marketed products, is more than 99% pure; offers high batch-to-batch consistency and is scalable under commercial GMP. MilliporeSigma is one of a few companies in the world able to produce the quantities needed for lipid nanoparticle manufacturing and meet the quality requirements for mRNA therapeutics.

The launch of this new product follows the company’s acquisition of AmpTec, a Hamburg, Germany, based mRNA contract development and manufacturing organization. By combining AmpTec’s PCR-based mRNA technology with MilliporeSigma’s extensive expertise in lipids manufacturing, MilliporeSigma can provide a truly integrated offering across the mRNA value chain. MilliporeSigma has more than 20 years of experience developing and manufacturing high-quality lipids, following GMP processes.

MilliporeSigma is collaborating with more than 50 companies to support their efforts in the development and production of Covid-19 vaccines and treatments, providing custom lipids, as well as other critical raw materials, processing equipment and services used in mRNA drugs and vaccines manufacturing. Beginning February 2021, the company announced the extension of its strategic partnership with BioNTech to significantly accelerate the supply of urgently needed lipids and increase the quantities to be delivered toward the end of 2021. The lipids will be used for the production of the Pfizer-BioNTech Covid-19 Vaccine.