Lipids are a key component of mRNA-based vaccines and therapeutics and given the COVID-19 pandemic, there is a huge global demand for these constituents, said Andrew Bulpin, head of process solutions, Merck.
The company is rolling out an enhanced synthetic cholesterol product to market nine months early,
At the start of February this year, it 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. But the company said it tapped into its two decades long experience in developing and manufacturing lipids to ensure release ahead of that schedule.
“Our new synthetic cholesterol product is more than 99% pure, offers high batch-to-batch consistency and is scalable under commercial GMP,” said Bulpin.
In January, Merck acquired AmpTec, a Hamburg, Germany, based mRNA contract development and manufacturing organization (CDMO). That deal also helped advance the early delivery of the cholesterol product.
Bulpin said that PCR technology is another important component of mRNA manufacturing and that AmpTec uses a differentiated PCR-based technology for mRNA manufacturing, which has shown to have clear benefits over other manufacturing technologies, including advantages in homogeneity, purity, activity and flexibility, higher quality and improved performance, as well as flexible capping options to reach specific performance requirements.
He told us the combination of AmpTec’s PCR-based mRNA technology with Merck’s expertise in lipids manufacturing is key to “our integrated offering across the mRNA value chain, significantly decreasing supply chain complexity and enhancing speed-to-market.”
Merck flagged that it is one of only a few companies that produces lipids in quantities needed to meet demand for mRNA therapeutics.
Manufacturing lipids in Schaffhausen, Switzerland, Darmstadt, Germany and in St Louis, Missouri, US, Merck says it is collaborating with over 50 manufacturers to support them in the development and production of their COVID-19 vaccines and treatments, providing custom lipids, as well as other critical raw materials, equipment and services used in mRNA drugs and vaccines manufacturing.
March this year also saw Merck announce a €25m (US$30.4m) investment in a single-use assembly production unit at its facility in Molsheim, France, saying that many biopharmaceutical manufacturers are turning to single-use technologies for their flexibility, cost savings, speed and reduced risk, leading to double-digit market growth for this segment.
"The coronavirus pandemic has accelerated this trend, with most programs using single-use production templates,” said Chris Ross, interim sector head, Life Science, Merck, at the time.
The company also recently announced expansion projects at its sites in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California; Madison, Wisconsin; Jaffrey, New Hampshire; and Danvers, Massachusetts. At the latter site, Merck is working to double the local single-use production capacity by the end of 2021.