Merck Presents Fully Integrated mRNA Services

First Provider Spanning All Critical Phases of mRNA Development, Production and Commercialisation

26.09.2023 - Merck is the first CTDMO (contract testing, development, and manufacturing organization) to offer an integrated service covering all critical phases of mRNA development, manufacturing, commercialization, and related products and testing services. The company today opened two new GMP-compliant manufacturing facilities for mRNA APIs in Darmstadt and Hamburg, Germany.

“mRNA has emerged as the breakthrough technology of this century, providing great promise to not only treat, but potentially cure, a wide array of diseases such as cancer, heart disease, and muscular dystrophy,” said Dirk Lange, Head of Life Science Services, Life Science business sector of Merck. “We are now the first CTDMO to streamline the entire mRNA process for our clients.”

The new sites are part of the company’s ongoing € 1 billion investment to advance mRNA technologies and build its global mRNA network and capabilities. Key acquisitions of companies such as AmpTec and Exelead also are included in the drive for mRNA advancement.

The € 28 million investment the Darmstadt and Hamburg sites adds 75 new jobs, providing clients mRNA services from pre-clinical to commercial. This includes analytical development and biosafety testing for mRNA technologies. PCR-based technology for clinical and commercial mRNA manufacturing is also available. The integrated offering can decrease complexities through streamlined and harmonized processes, increasing speed-to-market.

Merck has collaborated with researchers since the 1990s to ensure they have the critical components and raw materials needed to explore mRNA’s potential. Merck’s mRNA, custom and portfolio lipids, LNP and fill/finish CTDMO services are offered throughout its global network of sites in Schaffhausen, Switzerland; Indianapolis, Indiana, USA, Darmstadt, and Hamburg, Germany.

“As a researcher working on finding cures with mRNA technology and as a believer in its curative promise, collaborating with Merck has helped to advance my research in finding a cure by leveraging mRNA’s promise for muscular dystrophy,” said Simone Spuler, head of the Myology Lab at the Experimental and Clinical Research Center (ECRC), a joint institution of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and Charité - Universitätsmedizin Berlin.

Merck’s Millipore® CTDMO Services also provide pre-clinical through commercial capabilities for monoclonal antibodies and recombinant proteins (mAb and r-proteins), viral vectors (VV), small molecules and high-potent active pharmaceutical ingredients (HPAPI), antibody-drug conjugates (ADCs) as well as integrated analytical development, biosafety testing, and product characterization.

Millipore® CTDMO Services are part of the Life Science Services business unit, which together with the Process Solutions business is one of Merck's “Big 3” growth drivers. The company aims to increase its Group sales to approximately € 25 billion by 2025. Around 80% of the planned sales growth is to come from the “Big 3” businesses.


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