Merck to Become First Provider to Offer Fully Integrated mRNA Services

News Release

• New sites at Darmstadt and Hamburg complement Merck’s global integrated mRNA service network with pre-clinical to commercial capabilities
• Company’s Millipore^® CTDMO Services now encompass all key stages of mRNA technologies, lipids, lipid nanoparticles (LNP) and fill/finish, including key products and biosafety testing
• Expansion part of company’s ongoing € 1 billion investment plan to advance mRNA technologies

Darmstadt, Germany, September 26, 2023 – Merck, a leading science and technology company, today became the first CTDMO (contract testing, development and manufacturing organization) to offer integrated services for all critical stages of mRNA development, manufacturing, and commercialization, including products and testing. The company opened two new GMP-grade mRNA drug substance manufacturing sites 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, as well as through key acquisitions such as AmpTec and Exelead. The € 28 million investment into the new GMP mRNA drug substance manufacturing sites at Darmstadt and Hamburg adds a total of 75 new jobs, providing clients mRNA services at all scales and applications from pre-clinical to commercial. This includes analytical development and biosafety testing specifically designed for mRNA technologies. Merck also offers differentiated PCR-based technology for clinical and commercial mRNA manufacturing, providing clients with high-quality mRNA. With this integrated offering, Merck can significantly decrease complexities through streamlined and harmonized processes and enhance clients’ speed-to-market.

Since the 1990s, Merck has collaborated with researchers to ensure they have the critical components and raw materials needed to explore mRNA’s potential. Merck’s unique combination of mRNA expertise, technologies, regulatory knowledge, and product portfolios streamlines mRNA manufacturing and testing. 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 Dr. 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.