MilliporeSigma opens a commercial facility for CTDMO services in France

FRANCE – MilliporeSigma’s life science business sector has opened a commercial facility in Martillac, France, for its new contract testing development and manufacturing organization (CTDMO) services offering.

MilliporeSigma, the life sciences division of Germany’s Merck KGaA, announced plans to invest €175 million (US$174 million) and create 500 jobs at its French sites in June 2021.

As part of that, a €50 million (US$49.4) facility has opened in Martillac, south of Bordeaux, adding a 2,700 square-meter single-use drug substance plant to produce monoclonal antibodies (mAbs) and other recombinant proteins from an integrated site featuring single-use equipment and onsite regulatory, quality, and technical experts.

The Martillac facility will produce commercial monoclonal antibody drug substances in quantities up to 2,000 L and is part of a larger MilliporeSigma investment in France.

MilliporeSigma named Y-mAbs as one of its customers set to benefit from this increased capacity.

Y-mAbs Therapeutics is a commercial-stage biopharmaceutical company focusing on pediatric immunotherapies leveraging the company’s CTDMO services.

The Martillac facility is designed to operate at peak efficiency and can quickly switch from 200 to 2000 liters of drug substance.

It also includes two 2000-liter bioreactors in a single manufacturing suite, increasing capacity and flexibility.

Clients in the Life Science business sector can streamline and accelerate the commercialization process by eliminating the need for tech transfer and scale-up between clinical and commercial stages by leveraging cutting-edge technology and a proven quality system.

Martillac facility will create 150 jobs by 2024, according to the company. A total of 350 new jobs will be created at MilliporeSigma’s Molsheim facility, located west of Strasbourg, which received a €25 million (US$24.7 million) expansion as part of the June 2021 announcement.

The Molsheim site has also been expanded, with a €130 million (US$128.5 million) boost last month to increase single-use equipment production capacity.

Elsewhere, MilliporeSigma has completed the first phase of its China Biologics Testing Center, which includes the establishment of a viral clearance (VC) laboratory in Shanghai.

MilliporeSigma claims the 5,000 square meter facility is the “first of its kind” for the company in China.

According to the company, the US$28 million VC laboratory helps meet the country’s double-digit demand for VC services by allowing customers to conduct viral clearance studies locally from pre-clinical development to commercialization.

MilliporeSigma claims that by adding viral clearance study capacity, it is supporting one of the most critical steps in drug development.

According to the company, the studies are critical in the Investigational New Drug (IND) and Biologics License Application (BLA) processes, which are required by regulatory agencies before moving to commercial production.

MilliporeSigma anticipates that the VC laboratory will generate approximately 120 jobs by 2023, with the second phase of the center opening late next year, offering cell line characterization as well as release testing services.

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