Merck launches synthetic cholesterol product to meet high demand for lipids

To meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics, Merck has launched a new, high-purity synthetic cholesterol product, nine months ahead of schedule, a statement from the company said.

It also said that the launch of this new product follows the company’s acquisition of AmpTec, a Hamburg, Germany-based mRNA contract development and manufacturing organisation. By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, Merck can provide an integrated offering across the mRNA value chain.

“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 – Process Solutions, Life Science, Merck.

“With the introduction of our new SAFC synthetic cholesterol product, we have increased our capacity by 50 times, helping biomanufacturers bring life-saving therapies to patients faster,” he added.

This neutral lipid, used in commercially marketed products, is more than 99 per cent pure; offers high batch-to-batch consistency and is scalable under commercial Good Manufacturing Practice (GMP). Merck is one of a few companies in the world able to produce the quantities needed for lipid nano-particle manufacturing and meet the quality requirements for mRNA therapeutics, according to the statement.

In addition to it, Merck is collaborating with over 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.

In early 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, said the statement.