Daiichi Sankyo Co., Ltd. is a world leading original research innovative pharmaceutical enterprise with a century long heritage. Supported by its proprietary DXd technology platform, it holds a leading global position in the ADC (Antibody Drug Conjugate) segment. Its ADC new drug manufacturing building located in Zhangjiang, Shanghai, represents a total investment of RMB 1.1 billion. As one of China’s first pilot sites for cross border segmented manufacturing of biological products, it is Daiichi Sankyo’s sole formulation production base in China, established to build local production capacity for oncology biologic medicines.The entire site strictly adheres to Chinese GMP, ICH Q7, Japanese PMDA, as well as US FDA and European quality standards. It is equipped with a full suite of sophisticated analytical instruments to enable automatic data traceability. Annual audits are regularly conducted by NMPA, third party QA institutions and the corporate global quality headquarters.Wellthinic Technology delivered an integrated digital intelligent system for Daiichi Sankyo Pharma (Shanghai). Driven by data and intelligent management, the solution enables compliant and efficient operation across the full production workflow. It helps the customer build a modern biopharmaceutical smart manufacturing system featuring high standards, high reliability and high level integration.
Solution Description:
Adopting Siemens industrial digital platforms, the solution integrates three core systems: BMS Building Management System, EMS Clean environment Monitoring System and EnMS Energy Management System. As a holistic pharmaceutical digital solution featuring deep IT/OT convergence, it establishes a data driven end to end digital service system to realize intelligent management and control for the ADC new drug manufacturing building.WinCC serves as the upper level monitoring platform with native full process audit trail functionality. Closed loop PID algorithms deliver high precision and stable regulation of temperature, humidity and differential pressure within clean zones, ensuring compliant and controllable production environments for Grade C/D oral preparation workshops. All environmental parameters and equipment operating status are automatically archived long term with data tamper resistance, fully satisfying requirements of GMP, GAMP5 and regulatory data integrity inspections.
Expected Outcomes:
The project establishes a complete standardized GMP validation system.
All equipment operating statuses, system operations and parameter modifications are fully recorded, tamper-proof and traceable.
The system fully complies with GAMP5 guidelines and meets regulatory data integrity inspection requirements.
Committed to building a benchmark intelligent automatic control project for biopharmaceutical clean workshops, it provides reliable digital and compliant safeguards for the safe production of ADC new drugs.
