Thousand Oaks Biopharmaceuticals has two facilities in Nantong (Jiangsu) and Lin-gang (Shanghai), providing protein drug substance (DS) production services. Our quality system complies with NMPA, FDA, EMA GMP & PIC/S standards, delivering preclinical non-GMP toxicology batches, pivotal clinical supplies and commercial GMP DS production.

Both sites have passed EU QP audits. Nantong Base also holds a Drug Manufacturing License and has passed the combined drug registration & GMP Pre-Approval Inspection (PAI) four times. It has 5 conventional & 1 perfusion GMP DS lines, compliant with global regulations.

Shanghai ADC R&D & Manufacturing Center has 1 GMP DS line & 2 ADC DS lines, integrating mAb, ADC DS and drug product production on-site to avoid regulatory risks from segmented manufacturing.