BEIJING, Oct. 14, 2026 /PRNewswire/ — As synthetic biology expands into new applications, standardized manufacturing processes, reliable production data, and robust quality management systems are becoming increasingly important. Tsingke recently hosted an on-site customer quality audit conducted by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at its Chengdu manufacturing facility. The audit focused on four key areas: raw material traceability, equipment lifecycle management, computerized systems and data integrity, and biological sample management.
Representatives from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. inspect manufacturing equipment and quality control workflows at Tsingke’s Chengdu facility.
Audit Assesses Key Quality Controls Across Manufacturing Operations
Raw Material Traceability: Auditors reviewed material receipt and inventory records, certificates of analysis (COAs), and incoming material acceptance records. They also examined forward and backward traceability procedures to verify the connections between raw materials, manufacturing activities, finished products, and associated production records.
Equipment Lifecycle Management: The audit covered equipment qualification records, calibration certificates, routine maintenance records, and equipment status labeling. Auditors paid particular attention to how equipment qualification, maintenance, and monitoring are managed throughout the equipment lifecycle.
Data Integrity and Computerized Systems: Auditors reviewed validation documentation for computerized systems and access control procedures for systems including Core-System and U8 Cloud. They also examined data archiving, backup, and periodic review procedures to assess the controls in place to support the integrity and availability of production and quality data.
Biological Sample Management: The audit covered the full lifecycle of biological sample management, including sample receipt, identification, storage, transfer, retention, and disposal.
Together, these areas illustrate how Tsingke integrates quality management requirements into routine manufacturing procedures and operational controls.
From Quality Management to Intelligent Manufacturing: Advancing “AI + Molecular Manufacturing”
As molecular manufacturing expands to serve a broader range of applications, maintaining consistent quality and reliable production becomes increasingly important.
For Tsingke, standardized workflows, robust quality controls, and reliable production data provide the foundation for its “AI + Molecular Manufacturing” strategy. These capabilities create opportunities to apply artificial intelligence to production analytics, process monitoring, and process optimization.
Building on this foundation, Tsingke’s Gene Factory model integrates molecular manufacturing with digital technologies, aiming to coordinate and optimize operations across the production process rather than focusing on individual steps in isolation.
The quality systems and operational controls reviewed during the audit reflect the importance of standardized processes and reliable data in supporting more integrated, digitally enabled manufacturing operations.
Strengthening Capabilities for Scalable Molecular Manufacturing
Looking ahead, Tsingke will continue to refine its manufacturing processes and quality management systems while exploring opportunities to apply digital technologies and artificial intelligence to molecular manufacturing. These efforts are aimed at improving operational consistency, supporting manufacturing scalability, and strengthening long-term customer partnerships.
About Tsingke
Beijing Tsingke Biotech Co., Ltd. is a biotechnology company providing comprehensive solutions for research and therapeutic development. With expertise in molecular biology, genetics, and protein science, Tsingke offers custom DNA/RNA synthesis, gene cloning, protein expression, antibody discovery, and viral vector packaging (AAV, LV, AdV). Its ISO 13485–certified facilities and Class 100,000 cleanroom ensure consistent quality and reliability. Backed by advanced automation and a global scientific team, Tsingke accelerates innovation in drug discovery, functional genomics, and genetic engineering—empowering researchers worldwide with cutting-edge biomanufacturing solutions.
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