Bioworkshops and QuaCell Biotechnology,Co.,Ltd. (hereinafter referred to as ‘QuaCell’) jointly announce the strategic cooperation agreement to provide outstanding CHO-K1Q host cell platform and CDMO project services. The cooperation agreement combines the complementary technology advantages of both parties, connecting upstream and downstream processes, to provide more comprehensive, high-quality, and efficient technical services and solutions to biotechnology customers around the world.
Bioworkshops was founded in 2019 with the mission of providing customers with high quality, high efficiency, and economical one stop services. The company owns a 28,000 m2 building and land in Suzhou and has more than 100 employees. Our technical service team has rich experience in the development of biological drugs. The team spent only 3 months to build 1,700 m2 of process development facilities and establish quality control laboratories. This first phase provided cell line development, upstream and downstream process development, formulation and analytical method development for clinical products, and complete testing and release capability for GMP drug substance and drug products . Following on, it took merely 4 months to build the 4,800 m2 of GMP drug substance and drug product manufacture workshops which meet the requirements of FDA, EMA and NMPA regulations. Two 200-500L tandem disposable bioreactor production lines have been put into operation, and the 2×2,000L production line launched in Q3 of 2020 with the addition of four 2,000L bioreactors earmarked for 2021.
Currently, Bioworkshops are in the development of preclinical CMC for six antibody projects, and two or three projects will be ready for IND application in December 2020. Through this collaboration, Bioworkshops will work with QuaCell to solve cell line traceability and global commercial licensing issues for customers. Bioworkshops will also incorporate QuaCell’s technology in screening platforms for cell line construction and during the CMC process optimization phase to provide customers with more rapid, economic, and comprehensive services that enhances the advantage of Bioworkshops in biological medicine research and development.
As a strategic partner, QuaCell will provide Bioworkshops with their CHO-K1Q host cell platform that has a clear traceability record and a global commercial license. Building on the advantages of existing products and customized formulations, QuaCell will provide priority to supply their platform-based culture media to Bioworkshops, and assists in the development of culture media and process optimization as part of the CDMO services of Bioworkshops.
The two companies will integrate their expert biological product development resources, balance speed, quality and cost to achieve the common goal of excellent customer service. Each party will contribute in the areas of strength to develop highly productive new processes. This will bring biologic drugs to market faster as we continue to be a reliable partner for our customers.