Bioworkshops

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 t... o 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.Read More