New €25 Million BioReliance Testing Facility Opens at Merck KGaA Global Headquarters in Germany

MilliporeSigma opened a new €25 million BioReliance® testing facility at the company’s global headquarters in Darmstadt, Germany. The facility expands access to commercial drug substance and drug product release testing as well as stability testing for biopharmaceutical companies developing and commercializing therapies in Europe, according to the company. “As demand for biologics and novel therapies continues to grow, our customers need reliable, compliant testing capabilities closer to where their products are developed and commercialized,” said Paolo Carli, head of advanced solutions for the life science business of Merck KGaA. “Our new testing facility combines best-in-class analytical characterization services with more than 75 years of BioReliance expertise to help our European customers move critical therapies toward patients with greater speed and confidence.” The 2,000-square-meter facility is designed to help customers meet European requirements for in-region drug substance and drug product release testing and to expand the company’s ability to support customers from drug development through commercialization. The site will also offer GMP-compliant stability studies for monoclonal antibodies and cell therapies, addressing the growing demand for biologics testing across Europe. Located close to major clinical trial sites in Germany, France, Spain, the Netherlands, Belgium and Italy, the Darmstadt facility is strategically positioned to support biopharmaceutical companies seeking to release drug products into European markets, pointed out Carli. By adding these capabilities in the heart of Europe, the company is strengthening its support for customers managing increasingly complex development, quality and regulatory requirements, he added. A MilliporeSigma spokesperson noted that the BioReliance sites form a global testing network that allows customers to scale across geographies and work with the company across continents. Among the company’s leading technologies is the Blazar® platform, which moves the biosafety testing paradigm from traditional methods to rapid molecular approaches to significantly reducing testing timelines for virus detection. The Aptegra® CHO genetic stability testing streamlines a previously complex and time-intensive process into a single assay, continued the spokesperson. MilliporeSigma lists the opening of the Darmstadt facility as one of several significant investments the company has made to grow its global contract testing footprint. In 2024, the company opened a €290 million biosafety testing facility in Rockville, MD, and expanded biosafety testing capacity by 40% across its Glasgow and Stirling sites through a €22 million investment. The company also cites the new BioReliance facility as reflecting the firm’s continued commitment to its global headquarters in Darmstadt, where €2.5 billion has been invested since 2015.