MilliporeSigma Expands Newest Biologics Testing Center in Shanghai

Further develops its biosafety testing laboratories for local demand; New labs complete 2nd phase of company's €29 million Biologics Testing Center.

21 Nov 2023 | Burlington, Massachusetts, United States of America
  • Further develops its biosafety testing laboratories to meet local demand
  • New labs complete 2nd phase of company’s € 29 million Biologics Testing Center opened in 2022
  • Enhances BioReliance® testing services portfolio in the Chinese market

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, has opened the second phase of its new € 29 million Biologics Testing Center in China, adding 1,500 square meters to the lab, which opened last year.  These are the first biosafety laboratories for the company in this market, enabling clients to locally access a broad range of testing services for cell line characterization and lot release from pre-clinical development to commercialization.

“The opening of the facility deepens our partnership with our Chinese clients who are at the forefront of shaping modern medicine,” said Dirk Lange, Head of Life Science Services, Life Science business sector of Merck KGaA, Darmstadt, Germany. “The Biologics Testing Center in Shanghai now provides critical local services backed by our more than 75 years of global experience in the testing market.”

The first phase of investment provides testing services for viral clearance studies, a critical step in drug development. The second phase adds capabilities for cell line characterization that support biopharma customers to ensure the safety, purity, and identity of their cell banks. The testing center also offers cGMP-compliant lot release testing for unprocessed and purified bulk harvest to meet requirements for biologics entering preclinical and clinical studies, as well as licensed biologics.

With the completion of phase two of the facility, the Life Science business now offers a broad range of biosafety testing services for monoclonal antibodies, other recombinant proteins, and cell and gene therapies. The Shanghai facility joins the company’s global biosafety testing network with sites in Singapore; Stirling and Glasgow, UK; and Rockville, MD, USA, and shares the same global expertise, standards, and quality systems.

The company’s BioReliance® testing services portfolio offers clients leading innovation to ensure the safety and quality of the biopharma industry’s supply chain. As a leader in the biosafety testing industry, the company has more than 1,000 clients globally with industry-leading portfolio breadth for major modalities (mAbs, ADCs, CGT, mRNA, and vaccines).

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About the Life Science business of Merck KGaA, Darmstadt, Germany

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 28,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.

More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck KGaA, Darmstadt, Germany, visit www.emdgroup.com.

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