Cell Full Lifecycle Management Platform
Platform Overview
Intelligent Manufacturing for Pharmaceutical Enterprises
The platform provides automated, intelligent, digital, and compliant management throughout the entire pharmaceutical product lifecycle—from manufacturing to clinical application. It supports key intelligent manufacturing scenarios, including: Product research and development; Process development and optimization; Production planning and scheduling; Manufacturing operations; Warehouse and inventory management; Quality management and quality control; Equipment, operation, and maintenance①.
End-to-End Bidirectional Traceability
Built on a proprietary cell traceability architecture and a full-lifecycle data model with independent intellectual property, the platform enables comprehensive bidirectional traceability for cell therapy products. It supports complete traceability from donor to patient, as well as reverse traceability from patient back to donor, ensuring full product visibility and regulatory compliance throughout the manufacturing and clinical workflow②.
AI-Driven Intelligent Manufacturing
The platform leverages artificial intelligence③to optimize process design and manufacturing control while enabling intelligent equipment monitoring, predictive maintenance, and real-time process trend analysis. These capabilities support continuous process optimization, improve operational efficiency, and enhance the consistency and quality of cell therapy products.
1. Guidelines for Typical Intelligent Manufacturing Scenarios of Pharmaceutical Enterprises (2022 Edition) Ministry of Industry and Information Technology (MIIT)
2. Good Manufacturing Practice (GMP) Guidelines for Cell Therapy Products (Trial) National Medical Products Administration (NMPA)
3. Artificial Intelligence in Drug Manufacturing — U.S. Food and Drug Administration (FDA)
Platform Advantages
Full-scenario Coverage
Flexible Deployment Mode
Customized One-stop Services
Customized One-stop Services
Empower Industrial Digital Upgrade
Application Scenarios
The platform provides end-to-end traceability across the entire cell therapy workflow, covering sample collection and transportation, cell manufacturing, product distribution, and clinical application.
Medical Institution
Sample Collection
Logistics Company
Sample Transportation
Cell Company
Sample Reception – Production – Shipping
Logistics Company
Cell Transport
Medical Institution
Clinical Application
Cell Company
Application Survey
It supports comprehensive lifecycle data management, including basic information, application records, and complete operational data throughout every stage of the process.
Sample Collection Management
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Electronically informed consent management
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Donor information registration
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Unique sample identification and coding
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Comprehensive sample information recording
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Standardized sample collection documentation
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Transportation Traceability
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Customized transportation planning
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Automatic shipment record generation
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Real-time shipment tracking
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Continuous monitoring of environmental conditions within transportation containers
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Automatic receipt confirmation and record archiving
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Cell Manufacturing Management
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Standardized sample receipt verification
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Intelligent production scheduling
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Comprehensive electronic batch production records
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Closed-loop quality management throughout the manufacturing process
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Standardized cell cryopreservation and inventory management
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Transportation Traceability
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Customized transportation planning
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Automatic shipment record generation
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Real-time shipment tracking
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Continuous monitoring of environmental conditions within transportation containers
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Automatic receipt confirmation and record archiving
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Clinical Application Management
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Patient health record management
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Standardized clinical treatment documentation
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Structured patient follow-up management
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Adverse event monitoring and documentation
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Automatic generation of clinical application summary reports
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Platform Advantages
Integrated Hardware and Software
End-to-End Process Visualization
Comprehensive Quality Management
Remote Audit and Inspection
Robust Data Security
End-to-End Traceability
Comprehensive Regulatory Compliance
AI-Driven Intelligent Manufacturing
Product Introduction
R&D Software Series
Realizes digital laboratory management, strengthens cross-team collaboration, and provides solid compliance assurance for whole R&D procedures.
Production Software Series
Based on comprehensive cell quality control strategies, it covers management of both manual and automated cell preparation workflows.
Quality Inspection Software Series
Effectively improves inspection efficiency and delivers stable and reliable product quality assurance.
Resource Management Software Series
Realizes digitalized full-process management covering six core production elements: Man, Machine, Material, Method, Environment and Measurement.
Quality Management Software Series
Guarantees full production compliance with GMP specifications and supports bidirectional full-lifecycle traceability of cell therapy products.
Operation Flow
