MilliporeSigma’s life science business sector opened a commercial facility for its new contract testing development and manufacturing organization (CTDMO) services offering at the company’s site in Martillac, France. MilliporeSigma is the U.S. and Canada life science business of Merck KGaA (Darmstadt, Germany).
The 2,700-square-meter facility will provide global supply of commercial drug substances, including monoclonal antibodies and other recombinant proteins, from an integrated site featuring single-use equipment and onsite regulatory, quality, and technical experts, according to Dirk Lange, head of life science services, life science business sector of Merck KgaA.
“Our clients are pioneering modern medicine and managing multiple partners, supply chain needs, and complex priorities,” said Lange. “With this facility and our global Millipore® CTDMO services network, we offer differentiated services, including templates for drug development, manufacturing, and commercialization to accelerate molecules to market.”
Lange noted that the expansion will support clients such as Y-mAbs Therapeutics, a commercial-stage biopharmaceutical company focusing on pediatric immunotherapies leveraging the company’s CTDMO services. “With the life science business sector’s support, we’ve brought our product candidate for pediatric brain cancer to patients in roughly half the time than the approximate 12 years it typically takes to bring a biologic to market,” said Torben Lund-Hansen, CTO, head of technical operations, Y-mAbs.
The Martillac facility is designed to operate so that it can rapidly pivot from 200 to 2000 liters of drug substance, added Lange. It also features two 2000-liter bioreactors in one manufacturing suite. The system has been set up to allow clients to streamline and accelerate the commercialization process by eliminating the need for tech transfer and scaleup between clinical and commercial stages and to integrate product characterization and safety testing, explained Lange.