GenScript ProBio announces today Nanjing antibody and protein drug manufacturing site has successfully passed an audit by a European Union Qualified Person (QP) in Oct. 2021. This indicates that the GenScript ProBio Nanjing manufacturing site complies with European pharmaceutical GMP and has the ability to provide high quality clinical products and biologics CMC services for European and international clients. This is the first QP audit of GenScript ProBio, and it constitutes a continuing improvement of the compliance status of quality system against Chinese domestic and international regulatory requirements. The facility has had various successful audits by clients and third-party auditors from China, US, Asia, and now Europe.
The lead auditor supports pharmaceutical/ biotechnology clients in clinical research, development, and commercial manufacturing. Due to Covid-19 travel restrictions the audit was remotely conducted by two auditors over a period of two days. The inspection was conducted according to EudraLex Vol 4 (EU GMP) and ICH guidelines. The audit scope covered production system, facility and equipment management, QC, QA, material management, CSV and other systems. The auditors commented they found the facility operates at a very high level of GMP compliance, the staff is knowledgeable, and the quality systems are adequately structured and correspond to the current recognized and scientific standard. They concluded the facility operates in full compliance to EU regulatory standards and guidelines.
GenScript ProBio Nanjing GMP plasmid manufacturing center follows the international leading design concept and is a true "zero-crossover, unidirectional flow" plant, which meets FDA, EMA and NMPA regulatory requirements. Strict physical isolation is adopted in the whole facility, which ensures the manufacturing of multiple samples at the same time. In September 2021, GenScript ProBio announced a signing of a clinical manufacturing service agreement with German companies named Synimmune.