Merck has launched a new, high-purity synthetic cholesterol product to meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics. The product has been launched 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, Life Science, Merck. “With the introduction of our new SAFC synthetic cholesterol product, we have increased our capacity by 50 times, helping bio manufacturers bring lifesaving therapies to patients faster.”

The 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 GMP. 

The launch of the 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 a truly integrated offering across the mRNA value chain. Merck has more than 20 years of experience developing and manufacturing high-quality lipids, following GMP processes. The company provides regulatory support through all phases of clinical development and commercialisation, as well as deep analytical expertise.