Merck's first biosafety testing facility in China aims to meet local needs

The opening of the new laboratory marks the successful completion of the first phase of the new biosafety testing laboratory center.

The second phase of the expansion includes the construction of cell line validation and batch release testing services.

September 21, Merck, a leading global technology company, announced the opening of the first phase of its EUR 29 million biosafety testing laboratory in China, a virus clearance validation laboratory. The 5,000 square meter center is Merck's first laboratory of its kind in China. The Phase I opening will enable customers to conduct virus clearance studies from preclinical development to commercialization locally and will meet the double-digit growth in demand for virus clearance validation services in China. This viral clearance validation lab will add approximately 120 jobs in 2023.

Dirk Lange, Global Head of Life Sciences Services for Merck's Life Sciences business, said "The opening of the Center's Viral Clearance Validation Laboratory marks a new chapter in our collaboration with our Chinese customers who are reshaping the frontiers of modern medicine. This lab and subsequent openings will provide our Chinese customers with key local services, backed by 75 years of experience in the global biopharmaceutical testing market."

The Center provides viral clearance validation services in Phase I. Viral clearance validation is one of the most critical steps in drug development, providing critical support for clinical investigation approval of new drugs (IND) and biologics launch applications (BLA). Regulatory agencies around the world require completion of the IND and BLA processes before clinical trials can be completed and commercial production can proceed. The Center's Phase II facility will open in late 2023 and will provide cell line validation and lot release testing services. The Viral Clearance Validation Laboratory in Shanghai will be an important member of Merck's global network of viral clearance validation services. The other laboratory centers offering the service are located in Singapore, Stirling, UK and Rockville, MD, USA, each sharing the same global expertise, standards and operational systems.

Marc Jaffré, Managing Director of Merck Life Sciences China, said "The opening of this lab marks another important milestone in our strategic investment in China and underlines our proactive efforts to play a more important role for our customers and partners in China. With strong growth in the coming decade, we look forward to attracting more ambitious local talent to work together to meet market needs."