MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced that its Life Science business sector has opened a commercial facility for its new Millipore CTDMO Services offering at the company’s site in Martillac, France. The 2,700-square-meter facility will provide global supply of commercial drug substances, including mAbs and other recombinant proteins, from an integrated site featuring state-of-the-art single-use equipment and onsite regulatory, quality and technical experts.
“Our clients are pioneering modern medicine and managing multiple partners, supply chain needs and complex priorities and are turning to our company to help them navigate the complexity and provide flexibility and scale,” said Dirk Lange, Head of Life Science Services, Life Science business sector of Merck KGaA, Darmstadt, Germany. “With this facility and our global Millipore CTDMO Services network, we offer truly differentiated services, including templates for drug development, manufacturing and commercialization to accelerate molecules to market with one experienced partner.”
This expansion will support clients such as Y-mAbs Therapeutics, Inc., 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. “Their end-to-end process development and GMP manufacturing services were key to achieving this milestone.”
The Martillac facility is designed to operate at the highest levels of efficiency and can rapidly pivot from 200 to 2000 liters of drug substance. It also features two 2000-liter bioreactors in one manufacturing suite to increase capacity and flexibility. Leveraging state-of-the-art technology and a proven quality system allow the Life Science business sector’s clients to streamline and accelerate the commercialization process by eliminating the need for tech transfer and scale-up between clinical and commercial stages. This differentiated CTDMO services offering is purpose-built and seamlessly integrates product characterization and safety testing to accelerate the development and commercialization process.
With more than 30 years of drug development, material science and process technology expertise, Millipore CTDMO Services offerings span pre-clinical to commercial phases, including testing, across multiple modalities including mAbs, highly potent active pharmaceutical ingredients, antibody-drug conjugates, viral vector therapies, mRNA, and lipid nanoparticle formulation. This includes hardware and software, single-use consumables, and raw materials. The company’s network includes sites throughout Europe, the U.S., and Asia.
The company’s Millipore CTDMO Services are part of the recently formed Life Science Services business unit, which, along with the Process Solutions business, is one of its “Big 3” growth drivers. The company aims to increase its Group sales to approximately € 25 billion by 2025. To achieve its growth targets, the company plans to increase its total investments between 2021 and 2025 significantly compared with the period from 2016 to 2020.
Recently, the company announced expansion projects in its Life Science business sector in Verona and Sheboygan, Wisconsin, USA; Cork, Ireland; Wuxi, China; Darmstadt, Germany; Buchs, Switzerland; Carlsbad, California, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA, Molsheim, France, and Shanghai, China. These expansions are part of an ambitious, multi-year program to increase the capacity and capabilities of the company’s Life Science business sector to support the growing global demand for lifesaving medications and to make significant contributions to public health.