Chemistry, Manufacture and Control (CMC)
Evive utilizes cutting-edge biotechnologies to discover, develop, and produce biopharmaceutical therapies. Our integrated drug development and manufacturing expertise relates to mammalian cell line and culture technology, streamlined purification platform, comprehensive analytics and formulation development. Our CMC team is experienced at biopharmaceutical lifecycle management, i.e., from DNA to post-commercial operations.
Evive Beijing is a mammalian (CHO) based biologics manufacturing facility located in the eastern region of the Beijing Economic Development Area (BDA). Evive Beijing is a wholly-owned subsidiary of Evive Biotechnology Ltd.
The facility was built to produce investigative products for Evive’s global clinical trials as well as to meet Evive’s product commercialization needs of its innovative biopharmaceutical products. The FDA approved the F-627 Phase III clinical filing using the materials produced from Evive Beijing.
Evive Beijing’s core team is comprised of experts with global pharmaceutical company experience and in the CMC fields with substantial experience in planning, design, construction, commissioning, validating and regulatory filing (FDA/EMA/CFDA). The team is implementing a world-class Quality Management System (QMS) to ensure product quality, patient safety, and operational compliance with cGMP guidelines.