MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a CTDMO (contract testing, development, and manufacturing organization) will 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.

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 preclinical 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 aims to decrease complexities through streamlined and harmonized processes and enhance clients’ speed-to-market.

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.

The company’s CTDMO services also provide preclinical 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.

“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.”