NANJING, China, Nov. 10, 2021 /PRNewswire/ -- GenScript ProBio announces 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 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 is the biologics CDMO segment of GenScript, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers.
GenScript ProBio's innovative solutions for antibody drug development include antibody drug discovery, antibody engineering and antibody characterization. In terms of biologics development service, GenScript ProBio has built a regulatory-compliant platform, from stable cell line development, host cell license, process development, analytical development to clinical manufacturing services, providing fed-batch and perfusion process to accelerate IND process and high quality material for clinical trials. GenScript ProBio has successfully delivered multiple CMC and GMP manufacturing projects.
GenScript ProBio's total gene and cell therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Our quality management systems ensure phase appropriate compliance, data integrity and traceability.