CDMO Services

Thousand Oaks Biopharmaceutical (TOBio), as a CDMO specializing in the large molecule sector, offers an integrated suite of CMC solutions from candidate molecules through clinical and commercial manufacturing. Operating with the philosophy of an "innovator's drug development perspective," the core technical team at TOBio possesses extensive experience in biologics CMC and regulatory filings. Members of the CMC technology team have led IND-enabling CMC development projects, facilitated IND submissions in both China and the US, supported NDA filings, and passed pre-approval inspections (PAI) for market entry. TOBio employs a dual-site CDMO strategy, with GMP production facilities currently located in Nantong, Jiangsu, and the Lingang area of Shanghai. These facilities offer comprehensive research and manufacturing services for monoclonal antibodies, bispecific antibodies, fusion proteins, and ADCs. For ADC drug development, TOBio's...