With the completion of the second phase, Merck now offers a comprehensive range of biosafety testing services for monoclonal antibodies, other recombinant proteins, and cell and gene therapies
An employee in a production facility for liquid crystals in Shanghai, China. (Credit: Merck KGaA, Darmstadt, Germany and/or its affiliates)
Merck, a science and technology firm, has concluded the second phase of its Biologics Testing Center in China, expanding the laboratory by an additional 1,500m2.
The facility, inaugurated last year, represents Merck’s inaugural biosafety laboratories in this market.
The development allows clients to avail themselves of a comprehensive array of testing services for cell line characterisation and lot release, covering the spectrum from pre-clinical development to commercialisation on a local scale.
Merck life science services and life science business sector head Dirk Lange said: “The opening of the facility deepens our partnership with our Chinese clients who are at the forefront of shaping modern medicine.
“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 initial phase of investment in the Biologics Testing Center focuses on delivering essential testing services for viral clearance studies, a pivotal stage in drug development.
In the subsequent phase, the facility has expanded its capabilities to encompass cell line characterisation, providing crucial support to biopharmaceutical customers in guaranteeing the safety, purity, and identity of their cell banks.
This testing facility is also equipped to conduct cGMP-compliant lot release testing for both unprocessed and purified bulk harvests, meeting the stringent requirements for biologics entering preclinical and clinical studies, as well as licensed biologics.
With the completion of the second phase, the company now offers a comprehensive range of biosafety testing services for monoclonal antibodies, other recombinant proteins, and cell and gene therapies.
The Shanghai facility is an integral part of Merck’s global biosafety testing network, which includes sites in Singapore, Stirling, and Glasgow, UK, as well as Rockville, Maryland, US. These locations share a unified commitment to global expertise, standards, and quality systems.
Merck’s BioReliance testing services portfolio stands at the forefront of innovation, ensuring the safety and quality of the biopharmaceutical industry’s supply chain.