MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, is 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 today 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 KGaA, Darmstadt, Germany. “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 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. MilliporeSigma also offers differentiated PCR-based technology for clinical and commercial mRNA manufacturing, providing clients with high-quality mRNA. With this integrated offering, the company can significantly decrease complexities through streamlined and harmonized processes and enhance clients’ speed-to-market.
Since the 1990s, the Life Science business of Merck KGaA, Darmstadt, Germany has collaborated with researchers to ensure they have the critical components and raw materials needed to explore mRNA’s potential. Its unique combination of mRNA expertise, technologies, regulatory knowledge, and product portfolios streamlines mRNA manufacturing and testing. The company’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 and Darmstadt and Hamburg, Germany.
“As a researcher working on finding cures with mRNA technology and as a believer in its curative promise, collaborating with the Life Science business of Merck KGaA, Darmstadt, Germany 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.
The company’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 KGaA, Darmstadt, Germany’s “Big 3” growth drivers. Merck KGaA, Darmstadt, Germany 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” growth drivers.