Shanghai Keji Pharmaceutical Cell Therapy Production and Traceability Project (CGTS)

I. Project Overview

Kehui Biomedical (Shanghai) Co., Ltd. (referred to as "Kehui Pharmaceutical", stock code: HK02171) is China’s first innovative enterprise focusing on CAR-T cellular immunotherapy. It is also a globally renowned R&D enterprise specializing in CAR-T cell therapy for solid tumors, with operation centers in both China and the United States. The company cooperates with world-class research institutions and well-known hospitals to conduct research on more tumor targets and indications at home and abroad. Kehui Pharmaceutical has chosen to implement the Cell Therapy Production and Traceability Solution (CGT) developed by Shanghai Hippocrates Health Technology Co., Ltd. (whose holding company is Shanghai Huihuan Information Technology Co., Ltd.). This solution aims to optimize the development and manufacturing of complex cell therapy processes, monitor the manufacturing processes and supply chains of cell therapy facilities through a unified digital platform, and help the enterprise ensure compliance, avoid risks, and improve efficiency.

II. Project Background

For cell and gene therapy, paper-based records undoubtedly increase the complexity of the already intricate processes and regulatory difficulties of cell and gene therapy. Hippocrates’s Cell Therapy Digital Platform is designed to optimize the development and manufacturing of complex cell therapy processes. It provides a unified digital platform to monitor the manufacturing processes and supply chains of your facilities, helping you ensure compliance, avoid risks, and enhance efficiency. This CGT digital solution consists of three parts: COI/COC (Certificate of Identity/Certificate of Conformance), production management, and quality suites, as shown in the figure below:

III. Specific Measures

(I) Overall Planning

Hippocrates’s Cell Therapy Solution has developed functional modules suitable for different stages. Through modular configuration, enterprises can select a solution that matches their development stage to launch digitalization as early as possible. This ensures that the company’s pharmaceuticals meet regulatory requirements and accelerates the launch of pharmaceuticals.

(II) Business Model

Through four-phase business planning and digital function implementation, Hippocrates’s Cell Therapy Solution greatly helps enterprises free themselves from complicated production, manufacturing, and supply chain processes. Instead, enterprises can focus solely on improving the effectiveness and safety of cell and gene therapy drugs.

(III) Technical Architecture

The CGT Solution is one of the solutions based on Hippocrates’s Aotai Digital Platform. Aotai is a digital platform jointly built by Hippocrates’s industry experts and IT experts. With "Quality Compliance Expert" as its management philosophy and market positioning, it helps enterprises improve their quality compliance level, meet industry supervision, enhance enterprise management capabilities, and accelerate the launch of more safe, effective, and high-quality products.

The applications on the Aotai Platform can be customized to an enterprise’s quality system according to its needs. The built-in configurable tools include multiple quality management functions, so there is no need for customization or programming to implement certain special processes. Trained personnel can quickly customize forms, decision trees, and dashboards to meet specific business needs.

The excellent design of the Aotai Platform ensures that users can quickly access large volumes of records and data, thereby improving work efficiency. The "intelligent loading" of forms minimizes loading time. Frequently used data is cached to maximize network bandwidth utilization. Data is stored in an effective manner, and the distributed architecture is optimized for server expansion. Access efficiency is greatly improved through standard APIs, including: automatic email notifications, SMS notifications, and dashboard alert integration into workflows, which significantly reduces the risk of missing tasks or approvals. The background task submission and management mode supports users to perform other tasks simultaneously. A standard intermediate service layer is provided to support integration with any third-party system, facilitating data exchange between Aotai and other application systems.

IV. Construction Achievements

(I) Enterprise Achievements

Hippocrates’s Cell Therapy Production and Traceability Digital Solution can help enterprises better meet GMP (Good Manufacturing Practice) regulatory requirements, optimize production processes, and comprehensively improve production management levels. The specific manifestations are as follows:

• End-to-end Sample Tracking: The digital solution can provide digital tracking services for the entire cold chain transportation of samples, from sample collection in hospitals to preparation in production bases, and then back to hospitals for reinfusion. This helps cell therapy enterprises establish a standardized product management system and ensure the quality and safety of cell therapy products.
• Digital Management of Production Processes: The digital solution manages the entire production process of cell therapy products, realizing digital compliance control over all links, including donor material receipt, production, testing, and release. This reduces the time and effort required for material transfer and batch release, and significantly lowers the risk of human error.
• Quality Control and Compliance: The digital system supports the analysis of production process data, which is conducive to the continuous optimization of production processes and the improvement of production management levels. At the same time, data is recorded throughout the production process, supporting traceability of the production process, ensuring data integrity and reliability, and meeting regulatory requirements of major regulatory markets.
• Data Management and Analysis: The digital solution provides centralized data management, including sample location tracking, sample temperature tracking, data storage and audit trails, data analysis and management, etc. This optimizes R&D processes and improves the efficiency of production batch management.
• Scientific Data Platform: Through data analysis functions, centralized data storage and analysis are realized, simplifying workflows, providing a single source of truth, and supporting platform expansion for integration with advanced equipment.
• Risk Control and Regulatory Burden Reduction: The digital process traceability system realizes real-time, online monitoring throughout the life cycle, reducing regulatory burdens, lowering the possibility of contamination of operation records during preparation, and ensuring the accuracy, authenticity, real-time performance, and immutability of operation records.
• Enhanced Decision Support: In-depth insights are provided through business intelligence functions, helping management make more informed decisions, optimize resource allocation, and improve processes.
• Promotion of Innovation and R&D: By providing detailed data analysis and report generation, the digital solution supports R&D teams to better understand process performance and accelerate the development and launch of new therapies.
• Supply Chain Optimization: The digital solution helps optimize supply chain management, realize tracking of cell preparation, transportation, and flow direction, and improve the transparency and efficiency of the supply chain.
• Patient Safety and Efficacy Tracking: Through a real-time intelligent platform, the digital solution supports the optimization of clinical treatment plans and the evaluation of efficacy tracking, ensuring patient safety and treatment effects.

(II) Social Achievements

The Cell Therapy Digital Solution not only improves the operational efficiency and product quality of cell therapy drug companies but also enhances control over complex production processes, meets regulatory requirements, and helps more excellent cell therapy products launch faster.

V. Related Solutions

• Solution 1: GMP Training Management Solution (TMS) for Pharmaceutical Enterprises
• Solution 2: GMP Quality Compliance Digital Solution (QCMS)

VI. Related Cases

• Case 1: Contract Manufacturing Quality Management Collaboration (OWL MAH) Project for Kobayashi Pharmaceutical
• Case 2: GMP Quality Compliance Digitalization (QCMS) Project for Zhejiang Zhenyuan Pharmaceutical
• Case 3: GMP Training Management (TMS) Project for Suzhou Fushilai Pharmaceutical