MilliporeSigma, the U.S. and Canada life science business of Merck KGaA headquartered in Darmstadt, Germany, has opened a €25 million ($29 million) BioReliance testing facility in Darmstadt, expanding its European capabilities for commercial drug substance and drug product release testing.

The 2,000-square-meter facility will provide commercial release testing and Good Manufacturing Practice (GMP)-compliant stability studies for biologics, including monoclonal antibodies and cell therapies. According to the company, the site expands its BioReliance testing network and supports customers from drug development through commercial manufacturing.

Located near major clinical trial hubs in Germany, France, Spain, the Netherlands, Belgium and Italy, the facility is intended to help biopharmaceutical companies meet European requirements for in-region drug product release testing and commercialization, according to the announcement. MilliporeSigma said staffing at the site will continue to expand in response to customer demand.

The facility also becomes part of the company’s global BioReliance testing network, which provides analytical characterization, biosafety testing, and quality control services across multiple regions.

Paolo Carli, head of advanced solutions for the life science business of Merck KGaA, said in a statement that locating testing capabilities closer to European drug developers is intended to support commercialization of biologics and other advanced therapies.

The Darmstadt facility is one of several investments the company has made to grow its global contract testing footprint. In 2024, the company opened a €290 million ($286 million) biosafety testing facility in Rockville, Maryland, and expanded biosafety testing capacity across its Glasgow and Stirling sites in Scotland through a €22 million investment.

More recently, the company partnered with ProtaGene, a protein characterization company headquartered in Heilbronn, Germany, to provide an integrated testing platform that combines protein characterization services with GMP testing infrastructure.

According to the companies, the collaboration is designed to support biologics developers from early-stage characterization through commercial release testing while streamlining project management and regulatory support.