mAb Manufacturing for ADCs

Thousand Oaks Biopharmaceuticals’ ADC R&D and GMP facility in Lingang, Shanghai provides a GMP-compliant naked monoclonal antibody (mAb) platform supporting ADC development. Based on established cell culture and purification technologies, quality control complies with ICH Q6B and China/EU/US regulatory standards. The platform supports customized antibody modifications to optimize conjugation, with scalable capacity from clinical to commercial supply and full global regulatory documentation. As one of the few domestic CDMOs with commercial naked-mAb capability, we help accelerate ADC programs while reducing development risk.

Core Capabilities

  • Cell banking and naked-mAb production at 200 L, 500 L, and 2,000 L scales.
  • Cytiva single-use bioreactors and chromatography systems; Millipore depth/virus filtration & ultrafiltration systems.
  • GMP commercial manufacturing suites meeting international registration standards.