The contract testing, development and manufacturing organisation (CTDMO) will now provide integrated services for all key phases of mRNA development, production, and marketing, including products and testing
MilliporeSigma opens two new sites in Germany with €28m investment. (Credit: PR Newswire/ MilliporeSigma)
MilliporeSigma, the US and Canada Life Science unit of Germany-based Merck, has announced the opening of two new Good Manufacturing Practices (GMP)-grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany.
The contract testing, development and manufacturing organisation (CTDMO) will now provide integrated services for all key phases of mRNA development, production, and marketing, including products and testing.
The latest manufacturing sites are part of Merck’s ongoing €1bn investment to enhance mRNA technology and expand its global mRNA network and capabilities, as well as through deals like acquisitions of AmpTec and Exelead in the last two years.
According to the company, the €28m investment in the new GMP mRNA drug substance manufacturing facilities in Darmstadt and Hamburg is expected to add a total of 75 new jobs.
The sites will offer mRNA services at all scales and applications from pre-clinical to commercial along with analytical development and biosafety testing specifically designed for mRNA technologies.
Additionally, the German firm offers PCR-based technology to produce mRNA for use in clinical and commercial settings.
Using the integrated offering, Merck can significantly reduce complexities through streamlined and coordinated processes and improve the speed-to-market of clients.
Merck Life Science business sector, Life Science Services head Dirk Lange said: “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.
“We are now the first CTDMO to streamline the entire mRNA process for our clients.”
Merck’s MilliporeSigma CTDMO Services offers pre-clinical via commercial capabilities for monoclonal antibodies and recombinant proteins (mAb and r-proteins), viral vectors (VV), and small molecules.
It also has capabilities for high-potent active pharmaceutical ingredients (HPAPI), and antibody-drug conjugates (ADCs) along with integrated analytical development, biosafety testing, and product characterisation.