Clover has two manufacturing facilities – one focused on commercial manufacturing in Changxing, and another in Chengdu, suppling R&D and clinical programs.
We have an in-house, commercial-ready biologics manufacturing facility in Changxing, Zhejiang province, China. This facility is prepared for the rapid scale-up and commercial production of SCB-2019 and has a footprint of 50,000 sq.m. and a with a total gross building floor area of approximately 32,000 sq.m.
Our Changxing facility adheres to the cGMP standards in accordance with the U.S., EU, and Chinese regulatory authorities. The Changxing facility has received certification by a Qualified Person (QP), a requirement to achieve EU cGMP standards. Additional pre-approval GMP inspections are expected during the global marketing authorization submission processes for SCB-2019 in 2021.
Our R&D and pilot manufacturing facility is located in Chengdu, Sichuan province, China and supplies materials for our pre-clinical, IND, and early-stage clinical trials. The facility site occupies approximately 3,300 sq.m and contains a 200L single-use and 150L stainless steel bioreactor capacity as well as multiple pilot-scale drug product (DP) filling lines. The Chengdu manufacturing facility will continue to supply materials for pre-clinical studies and early-stage clinical trials and support product candidate development.