Germany Merck Accelerates Tender

To meet the high demand for lipids a key component of mRNA-based vaccines and therapeutics Merck a leading science and technology company has launched a new high-purity synthetic cholesterol product nine months ahead of scheduleTapping 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 at Merck. 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.Merck 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 Mercks synthetic cholesterol product offers high purity scalability and consistent quality.This neutral lipid used in commercially marketed products is more than 99 percent pure offers high batch-to-batch consistency and is scalable under commercial GMP. Merck 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 companys acquisition of AmpTec a Hamburg Germany based mRNA contract development and manufacturing organization. By combining AmpTecs PCR-based mRNA technology with Mercks 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 commercialization as well as deep analytical expertise.Merck 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. 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.The company recently announced the addition of a single-use assembly production unit at its Life Science Center in Molsheim France. The company also recently announced expansion projects 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. These expansions are part of an ambitious multi-year program to increase the industrial capacity and Mercks capabilities to support growing global demand for lifesaving medications and to make significant contributions to public health.