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MilliporeSigma is poised to introduce an all-encompassing suite of mRNA services, marking a significant milestone in the industry

Wednesday, September 27, 2023

MilliporeSigma, the U.S. and Canada-based Life Science division of Merck KGaA, Darmstadt, Germany, has established itself as the pioneering CTDMO (Contract Testing, Development, and Manufacturing Organization) offering comprehensive services across all critical phases of mRNA development, manufacturing, and commercialization, including product development and testing. The company has recently launched two new GMP-grade mRNA drug substance production sites in Darmstadt and Hamburg, Germany. We are proud to be the first CTDMO to simplify the entire mRNA process for our clients.

These new facilities are part of the company's ongoing €1 billion investment aimed at advancing mRNA technologies and establishing a global mRNA network, bolstered by strategic acquisitions such as AmpTec and Exelead. The €28 million investment in the new GMP mRNA drug substance manufacturing facilities in Darmstadt and Hamburg has created 75 new job opportunities and allows the company to offer comprehensive mRNA services, spanning pre-clinical to commercial scales, including specialized analytical development and biosafety testing tailored for mRNA technologies. MilliporeSigma also provides unique PCR-based technology for clinical and commercial mRNA manufacturing, ensuring high-quality mRNA for clients. This integrated approach streamlines processes, reduces complexities, and accelerates time-to-market for clients.

Since the 1990s, Merck KGaA, Darmstadt, Germany's Life Science business has collaborated with researchers to provide essential components and raw materials for exploring mRNA's potential. Their combination of mRNA expertise, technology, regulatory knowledge, and product portfolios simplifies mRNA manufacturing and testing. The company offers mRNA-related services, custom and portfolio lipids, lipid nanoparticle (LNP) solutions, and fill/finish CTDMO services across its global network of sites in Schaffhausen, Switzerland; Indianapolis, Indiana, USA; and Darmstadt and Hamburg, Germany.

Dr. Simone Spuler, Head of the Myology Lab at the Experimental and Clinical Research Center (ECRC), expressed her gratitude: As a researcher dedicated to harnessing mRNA technology's curative potential, collaborating with the Life Science business of Merck KGaA, Darmstadt, Germany, has propelled my research in pursuit of a muscular dystrophy cure by leveraging the promise of mRNA.

In addition to mRNA services, Millipore® CTDMO Services encompass pre-clinical to commercial capabilities for monoclonal antibodies and recombinant proteins (mAb and r-proteins), viral vectors (VV), small molecules, and high-potency active pharmaceutical ingredients (HPAPI), as well as integrated analytical development, biosafety testing, and product characterization.

Millipore® CTDMO Services are part of the Life Science Services business unit, one of Merck KGaA, Darmstadt, Germany's key growth drivers, alongside the Process Solutions business. Merck KGaA, Darmstadt, Germany aims to achieve approximately €25 billion in Group sales by 2025, with around 80% of the planned sales growth anticipated to come from these "Big 3" growth drivers.

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