Merck Accelerates Lipid Production Scale-Up to Meet Pandemic Demand with New High-Purity Synthetic Cholesterol

DARMSTADT, Germany, May 26, 2021 /PRNewswire/ -- To meet the high demand for lipids (a key component of mRNA vaccines and therapeutics), leading science and technology company Merck has launched a new high-purity synthetic cholesterol product, nine months ahead of schedule.

Andrew Bulpin, Head of Process Solutions at Merck Life Science, said: “Leveraging 20 years of experience in developing and manufacturing high-quality lipids, we have designed a proprietary process to enable the new SAFC^®Synthetic cholesterol products were launched on the market nearly a year ahead of schedule. With the new SAC^®With the launch of the synthetic cholesterol product, our production capacity has increased 50-fold, enabling biomanufacturers to deliver life-saving therapies to patients more rapidly.”

Merck produces lipids at its facilities in Schaffhausen, Switzerland; Darmstadt, Germany; and St. Louis, Missouri, USA. While animal-derived and synthetic cholesterols are already available on the market, Merck’s synthetic cholesterol products are characterized by their high purity, scalability, and consistent quality.

This neutral lipid is intended for commercial products, with a purity exceeding 99%, high batch-to-batch consistency, and scalability to commercial GMP manufacturing. Merck is one of the few companies worldwide capable of producing the quantities required for lipid nanoparticle manufacturing while meeting the quality standards demanded by mRNA therapeutics.

The launch of this new product follows Merck’s acquisition of AmpTec, an mRNA contract development and manufacturing organization headquartered in Hamburg, Germany. By integrating AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipid production, Merck can deliver a truly integrated product portfolio across the entire mRNA value chain. Merck has over 20 years of experience in the GMP-compliant development and manufacturing of high-quality lipids. Merck provides regulatory support throughout all stages of clinical development and commercialization, complemented by in-depth analytical expertise.

Merck is collaborating with more than 50 companies to support the development and manufacturing of COVID-19 vaccines and therapeutics, providing customized lipids along with other critical raw materials, processing equipment, and services for the production of mRNA therapeutics and vaccines. In early February 2021, Merck announced the deepening of its strategic partnership with BioNTech to significantly accelerate the supply of urgently required lipids and increase delivery volumes by the end of 2021. These lipids will be utilized in the manufacturing of the Pfizer-BioNTech COVID-19 vaccine.

The company recently announced the addition of a new single-use assembly production facility at its Life Science Center in Molsheim, France. Additionally, Merck recently announced expansion projects at its sites in Darmstadt, Germany; County Cork, Ireland; Buchs, Switzerland; Carlsbad, California; Madison, Wisconsin; Jaffrey, New Hampshire; and Danvers, Massachusetts. At the latter facility, Merck is working to double local production capacity for single-use products by the end of 2021. These expansion initiatives are part of Merck’s ambitious multi-year plan aimed at enhancing industrial capabilities and manufacturing capacity to support the growing global demand for life-saving medicines and make significant contributions to public health.

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