Shanghai Taichu Biotechnology Co., Ltd. (Taichu Bio) has completed the preliminary establishment and preparation for its Drug Non-Clinical Safety Evaluation segment. Effective March 1, 2023, the segment will commence a comprehensive trial operation in full compliance with the Good Laboratory Practice (GLP) regulations.
Company Introduction
Located in the Life Blue Bay of the Lingang Special Area, Taichu Bio is a Contract Research Organization (CRO) specializing in providing pre-clinical research services for new drugs. Its main facility spans 16,000 m² and includes:
• SPF-level animal housing
• Conventional animal housing
• Animal Biosafety Level 2 (A-BSL2) laboratories
• Functional laboratories for pharmacodynamics, pharmacokinetics/toxicokinetics, toxicology, and molecular/cellular biology research.
The experimental animal facility obtained its Animal Use and Production License in January 2023, with five independent BSL-2 laboratories simultaneously registered.
01. Facility Construction
The facility features internationally renowned automation controls and advanced HVAC systems for precise environmental management. Designed for GLP compliance, operational efficiency, and sustainability, all facilities have completed validation and currently support ongoing pharmacodynamics, PK, and toxicology studies.
02. Team Building
Taichu Bio's GLP unit has established specialized departments (Toxicology, Bioanalysis, Pathology, QA) staffed by scientists and managers with extensive GLP experience. The organizational structure complies with NMPA, OECD, and FDA GLP standards.
03. Quality Systems
Over 300 GLP-compliant SOPs have been implemented, supported by a structured training program delivering ~6,000 training sessions since July 2022. All instruments and software systems are fully validated per GLP requirements.
04. Information Systems
A secure private cloud platform ensures data integrity. The operational infrastructure includes:
• Laboratory Information Management System (LIMS)
• No-code/low-code enterprise platform for operational management
• Proprietary Document (DMS) and Training (TMS) Management Systems
• Risk-based QA tools and online project/resource management
Approved by Group leadership, Taichu Bio's GLP unit initiated full trial operations on March 1, 2023. This milestone complements the company's established pharmacodynamics and pharmacokinetics research services, marking Taichu Bio's entry into comprehensive business operations.
Taichu Group Business Segments
" Advocate of Ethics and Integrity, Quest for Verity" represents the Group's core values. Subsidiaries include:
• Taichu Bio: Pre-clinical research
• AceMab: Antibody Discovery and Design
• Tarlead Biologics: Biologics Development and Manufacturing
• Tyzen: Drug formulation R&D and manufacturing
AceMab relocated to Taichu's Lingang headquarters in December 2022, while Tyzen and Tarlead Biologics held opening ceremonies in February-March 2023. The Taichu Group now provides integrated, high-level R&D services to advance China's pharmaceutical innovation.
