Recently, TOT BIOPHARM (Stock code: 1875.HK) gained the Compliance Inspection Report approved by the EU Qualified Person (QP). TOT BIOPHARM’s commercial antibody and antibody drug conjugates (ADC) manufacturing site in Suzhou Industrial Park headquarters have passed the QP audit with zero defect, which proves that the company’s commercial manufacturing site and quality management system comply with EU GMP standards.

This audit was conducted EU (Ireland) QP in accordance with Eudralex Vol 4 (EU GMP) and International Conference on Harmonization of Requirements for Registration Pharmaceuticals for Human Use (ICH) guidelines for antibody intermediate, ADC DS and ADC DP of an ADC drug developed by TOT BIOPHARM. The audit covered various aspects such as manufacture management system, quality management system, plant facility and equipment management system, validation and computerization system, validation and management of data integrity, material management system, testing and release management.

TOT BIOPHARM passed this audit in one go with zero defect and was highly recognized by the auditors. This is one of the few commercialization sites in China that have passed the EU QP certification for both antibody and ADC drugs; it is also another milestone in the quality management system of TOT BIOPHARM after passing the GMP on-site verification in China, which lays a solid foundation for TOT BIOPHARM to provide one-stop CDMO services for biologics that meet the requirements of EMA, NMPA and FDA drug regulations to its clients.

Dr. Jun Liu, CEO of TOT BIOPHARM, said:

The EU QP audit is one of the important steps in the globalization strategy of TOT BIOPHARM. The antibody drug manufacture plant and the chemical oral preparation manufacture plant of TOT BIOPHARM have passed the on-site verification of China’s drug registration and manufacture and GMP compliance. The passing of the EU QP audit proves that the quality management system of TOT BIOPHARM has been recognized by international professional organizations.

In the future, TOT BIOPHARM will strengthen its technology development and commercialization manufacture capacity, and continue to strengthen the advantages of quality management system to provide one-stop CDMO services for domestic and foreign clients with higher efficiency and better quality, empowering partners and driving high-quality industrial development.