Partnership with Jade Biomedical Fuels CMC Support in Asia
Clients in the APAC region will have access to greater regulatory support and capacity for a broad range of analytical services for the development of their biologic drugs, including comprehensive quality testing for cell and gene therapies, thanks to our new partnership with Jade Biomedical. As a premiere contract quality organization (CQO) based in Shanghai and Suzhou, China, Jade offers end-to-end GMP testing services built upon an in-depth understanding of quality systems that comply with the Chinese health authorities and global regulatory standards. In addition to analytical testing, Jade offers support for regulatory submissions, quality assurance, cold chain management, and facility design.
"Around the world, R&D efforts for cell and gene therapies are in high demand. Companies are seeking global partners who understand the complexities of this market, while also knowing how to navigate the nuanced regulatory environment in their region." – Birgit Girshick, CEVP of Discovery, Safety, Biologics and Avian Vaccine Services
Global Support for Emerging Biotech
Together, our two organizations meet a critical need for access to leading contract research and manufacturing services in Asia. Innovative companies in pursuit of cell, gene, and other biologic therapies can harness local CMC expertise, quality systems, and a global scientific network to support their development without having to invest in these in-house resources.
A newly opened second facility further expands Jade's capacity for the delivery of GLP/GMP analytical and microbiological services, enhancing support for our clients in the region. Having worked on 85% of the products approved by the FDA in 2018/19, Charles River is proud to partner with an organization known for its regional regulatory expertise. Together, Jade and Charles River can help clients extend their reach by developing products that meet the requirements of multiple markets.