MilliporeSigma Opens Two New GMP Manufacturing Sites in Germany for mRNA Production

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced on Sept. 26, 2023 that it has opened two new good manufacturing practice (GMP)-grade messenger RNA (mRNA) drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The addition of these sites makes the company the first contract testing, development, and manufacturing organization (CTDMO) to offer integrated services for all stages of mRNA development, manufacturing, and commercialization, including products and testing, according to a company press release.

Under an ongoing €1 billion (US$1.06 billion) investment, the new sites are part of the company’s goal to advance mRNA technologies and build its global mRNA network and capabilities. The acquisitions of AmpTec in January 2021 (1) and Exelead in February 2022 (2) were also part of this investment.

The company has invested €28 million (US$30 million) into the new Darmstadt and Hamburg GMP mRNA drug substance manufacturing sites. The new facilities add 75 new jobs and provide mRNA services at all scales and applications, from pre-clinical to commercial scale. Services include analytical development and biosafety testing specifically designed for mRNA technologies. In addition, MilliporeSigma offers differentiated polymerase chain reaction-based technology for clinical and commercial mRNA manufacturing, which results in high-quality mRNA.

“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, in the press release. “We are now the first CTDMO to streamline the entire mRNA process for our clients.”

“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,” 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, in the press release.

References

1. Merck KGaA, Merck KGaA, Darmstadt, Germany, Announces Acquisition of AmpTec to Expand mRNA Capabilities for Vaccines, Treatments and Diagnostics. Press Release, Jan. 7, 2021.

2. Merck KGaA, Acquisition of Exelead Completed, Plans to Invest More Than €500 Million in Technology Scale-Up. Press Release, Feb. 23, 2022.

Source: Merck KGaA