Release time：Sep 06, 2021
Sept 6, 2021, Mabwell, an innovation-driven biopharmaceutical company, announced that its subsidiary Jiangsu T-mab (hereinafter referred to as T-mab, Mabwell’s Taizhou Antibody Industrial Base ) had successfully passed the qualified person (hereinafter referred to as QP) audit performed by the EMA. Successfully passing the QP audit demonstrates that the T-mab has a manufacturing site and a quality management system that fully comply with the EU GMP requirements, which can fully guarantee the development and manufacturing of Mabwell high-quality clinical trial drugs.
The purpose of this QP audit is to confirm that the quality system and the GMP capability of the T-mab of Mabwell meet the requirements of the EU to support sample manufacturing and testing activities for clinical trials of drug candidates. A German QP auditor carefully inspected the plant facilities, quality system, manufacturing, warehousing, testing and release of the T-mab for a period of 5 days and gave a good appraisal. The auditor said: "This company has solid and sound business practices and quality objectives, high-quality and functional systems and procedures, well-maintained plant facilities and well-trained personnel, leaving us a professional impression."
T-mab obtained a drug manufacturing license in 2019. It has commercial manufacturing capacity, and complies with the GMP requirements of China, the United States and the EU. At present, the Taizhou Industrial Base of Mabwell has completed the preparations of clinical samples for 8 drugs candidates, and all the manufactured sample batches have passed verification.
