Seeing double: MilliporeSigma opens two mRNA manufacturing sites

MilliporeSigma claims it is the first provider to offer fully integrated mRNA services as it opens two manufacturing plants in Germany.

MilliporeSigma – the life sciences division of Germany’s Merck KGaA – has opened two messenger RNA (mRNA) drug substance manufacturing facilities in Darmstadt and Hamburg, Germany. As a result, the contract development manufacturing organization (CDMO) said it is the first to offer integrated services for all stages of mRNA development, production, commercialization, and testing.

“The development and manufacturing of mRNA therapies involves a highly complex value chain, in which many different suppliers are typically required,” Dirk Lange, head of Life Science Services, MilliporeSigma told BioProcess Insider.

“By offering integrated services for all critical stages of mRNA development and manufacturing, including products and testing, we can significantly decrease complexities throughout the value stream and harmonize processes to enhance clients’ speed-to-market, which in turn will help get life-saving therapies to patients faster.”

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The expansion is part of the firm’s ongoing $1.1 billion investment plan to develop mRNA technologies and capabilities. The company cited its $780 million acquisition of Exelead in January 2022 and its decision to buy Germany-based mRNA CDMO AmpTec in January 2021 as other efforts to build its mRNA network.

$29.7 million of the funding went towards the build-out of the two manufacturing sites. Both sites have been equipped with scalable and flexible manufacturing process platforms and can provide customers with “all key stages of mRNA technologies”. This includes lipids, lipid nanoparticles (LNPs), biosafety testing, and fill/finish services.

Furthermore, the Hamburg and Darmstadt facilities see the CDMO add a total of 75 jobs. The firm also said the two sites can offer differentiated PCR-based technology for both clinical and commercial mRNA production. In turn, it claimed this minimizes complexities and speeds up the clients’ time to market.

“We have expanded in all relevant departments and are hiring mRNA experts at various levels of seniority in the fields of quality, operations, process and analytical development to supply chain management. The positions are filled by offering developing opportunities to internal talent and bringing in experience and expertise from the external talent market. Future open positions will be identified and communicated when appropriate,” said Lange.

BioProcess Insider spoke to Lange before this latest news and he told us “due to the high level of CDMO competition in a space where biotech funding is being impacted by market challenges, companies are turning to whatever means necessary to differentiate themselves in this highly competitive industry.”