Eurofins Central Laboratory supports clinical trials in China’s regulatory landscape

Sandra Hageman, Director of Marketing, Eurofins BioPharma Services, Laboratory Testing, SandraHageman@eurofins.com

As per guidance from the Chinese National Medical Products Administration (NMPA) regulatory agency, samples taken in the context of a clinical trial are not be exported for laboratory testing abroad. Hence, to support domestic clinical trials in China, or global trials that include Chinese subjects in the study protocol, there is a need for a local central laboratory to assess novel drug compounds for safety and effectiveness. In support of these clinical trials, Eurofins Central Laboratory has been operating a wholly owned and globally harmonised testing facility since April 2008 to allow in-country testing. Local kit packing and distribution for domestic studies were added to the services portfolio in 2019.

In order to meet the increasing complexity of study protocols, the Eurofins Central Laboratory facility relocated to the new Eurofins China headquarters in Shanghai in 2021 to expand its current footprint and facilitate further growth, as well as to accommodate pivotal capacity and capability expansions.

Going beyond standardised safety testing, the Shanghai laboratory is also offering biomarker testing and has recently installed a Meso Scale Discovery (MSD) platform for multiplex biomarkerassays and immunoassays. The site is fully harmonised, so as to partake in the Eurofins PBMC network for effective harvesting, processing, cryopreservation, and shipping for storage or downstream analysis of peripheral blood mononuclear cells (PBMCs). Globally harmonised Flow Cytometry capabilities are available in all four Eurofins Central Laboratory facilities in China, the US, the Netherlands and Singapore. Furthermore, DNA extraction and Real Time PCR will be added to the portfolio of capabilities soon. This expansion of Central’s laboratory testing service offering will allow solution-based services and improve efficiencies in the drug development life cycle in compliance with the Chinese regulatory landscape.

For more information, visit www.eurofinscentrallaboratory.com