The new 2,000-square-meter site adds commercial release testing and GMP-compliant stability studies for biopharma customers targeting European markets.
MilliporeSigma has opened a new €25 million BioReliance testing facility at Merck KGaA, Darmstadt, Germany’s global headquarters in Darmstadt, expanding commercial drug substance and drug product release testing and stability testing for biopharmaceutical companies operating in Europe. The 2,000-square-meter site is designed to meet European in-region testing requirements and will provide Good Manufacturing Practice (GMP) (manufacturing quality standard)-compliant stability studies for monoclonal antibodies and cell therapies. The company said the location, near major clinical trial hubs in Germany, France, Spain, the Netherlands, Belgium and Italy, is intended to help customers navigate increasingly complex development, quality and regulatory demands while moving therapies toward commercialization. The facility joins the global BioReliance network, which MilliporeSigma says is backed by consistent quality standards and more than 75 years of biosafety and analytical testing expertise. The opening follows other recent investments, including a €290 million biosafety testing facility in Rockville, Maryland, USA, opened in 2024, a €22 million expansion that lifted biosafety testing capacity by 40% across Glasgow and Stirling, and approximately €2.5 billion invested in Darmstadt since 2015.