Merck has completed the second phase of its new €29m Biologics Testing Center in China adding 1500 sqm to the lab opened last year.
These are the first biosafety laboratories for Merck in this market, enabling clients to locally access a broad range of testing services for cell line characterisation and lot release from pre-clinical development to commercialisation.
“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.
“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 characterisation that support biopharma customers to ensure the safety, purity and identity of their cell banks.
The testing centre 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, Merck now offers a broad range of biosafety testing services for monoclonal antibodies, other recombinant proteins, and cell and gene therapies.
The Shanghai facility joins Merck’s global biosafety testing network with sites in Singapore, Stirling and Glasgow, UK, and Rockville, MD, US, and shares the same global expertise, standards and quality systems.
Merck’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, Merck has more than 1000 clients globally with industry leading portfolio breadth for major modalities (mAbs, ADCs, CGT, mRNA and vaccines).