Shanghai Taichu Biotechnology Co., Ltd. (hereinafter referred to as "Taichu Bio") was awarded the "Drug GLP Certification Certificate" by the National Medical Products Administration (NMPA) on January 19, 2024.
Taichu Bio's 18,000㎡ facility was completed and handed over in December 2022. Its animal facility obtained the "Laboratory Animal Use License" issued by the Shanghai Municipal Science and Technology Commission in January 2023. Five laboratories (including an independent SPF animal facility) received the Biosafety Level 2 Laboratory (BSL-2 Laboratory) registration certificates from the local Health Commission. Through the efficient and intensive quality system preparation efforts of all staff, the Taichu Bio GLP facility commenced trial operation in compliance with GLP standards on March 1, 2023. By October 2023, the Taichu Bio GLP facility had completed simulated trials for all projects included in its first certification application and submitted the GLP certification application to the NMPA. From December 11 to 15, 2023, a GLP certification inspection team dispatched by the Center for Food and Drug Inspection of the NMPA conducted a comprehensive GLP inspection of the Taichu Bio GLP facility.
During this five-day initial certification inspection, the inspectors conducted detailed checks on all aspects of Taichu Bio's management, including the quality assurance system, documentation system (such as SOPs), staffing and research capabilities, facility environment, equipment configuration, computerized systems, test articles, and archives. They also rigorously reviewed relevant study data. Taichu Bio's quality management system received recognition and high praise from the inspection team. One month after the inspection concluded, Taichu Bio was awarded the GLP certification certificate, covering all projects included in its initial certification application.
In addition to successfully passing the GLP inspection, Taichu Bio's various testing platforms – including Clinical Pathology, Histopathology, Bioanalysis, and Formulation Analysis – participated in proficiency testing programs organized by the National Institutes for Food and Drug Control (NIFDC), the Shanghai Center for Clinical Laboratory Quality Control, and other relevant industry bodies in 2023. All platforms passed with all indicators qualified, totaling over 80 testing indicators. Particularly noteworthy, the Clinical Pathology platform participated in two rounds of evaluation within the year, successfully passing all 67 indicators across six major testing categories and microscopic examination items, with excellent results. These outcomes fully demonstrate Taichu Bio's commitment to a rigorous quality system and its dedication to exquisite craftsmanship in its operations, providing a solid scientific and quality assurance foundation for the high-quality completion of toxicology study tasks entrusted by clients.
Furthermore, in January 2024, Taichu Bio successfully underwent and completed an on-site certification inspection by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). It is expected to receive the certificate issued by AAALAC before the summer of 2024.
In 2023, the Taichu Bio team worked cohesively, achieving remarkable results in expanding research capabilities, building digital platforms, implementing risk-based quality management, and enhancing animal welfare management. Moving forward, Taichu Bio will continue to strengthen institutional development and management, strictly conduct drug non-clinical safety evaluation work in accordance with GLP requirements, effectively help clients shorten the new drug development cycle, and expedite the safe market launch of drugs! Taichu Bio will always adhere to the philosophy of "Uphold Ethics and Truth, Achieve Client Success" to provide premium services for global clients.
