HIPPOCRATES

Huadao Biotechnology Cell Therapy Production and Traceability Project (CGTS)

I. Huadao (Shanghai) Biomedical Co., Ltd.: An Innovative Pioneer in the Cell Therapy Field

Huadao (Shanghai) Biomedical Co., Ltd. (hereinafter referred to as "Huadao Biotechnology") is an innovative enterprise focusing on the R&D and application of cell therapy technologies, with remarkable achievements especially in the field of CAR-T cellular immunotherapy. The company is committed to overcoming difficult diseases such as solid tumors through cutting-edge cell therapy technologies, bringing new hope to patients. Huadao Biotechnology has established R&D centers and clinical cooperation bases both domestically and internationally, and conducts in-depth cooperation with numerous top research institutions and well-known hospitals to promote the clinical application and industrialization of cell therapy technologies.

Against the backdrop of the rapid development of the cell therapy industry, Huadao Biotechnology recognizes that traditional production and traceability management models can hardly meet the needs of increasingly complex regulatory requirements and efficient production. To optimize the production process of cell therapy products, improve quality management standards, and ensure compliance, Huadao Biotechnology has decided to introduce Hippocrates’s Cell Therapy Production and Traceability Solution (CGTS), opening a new chapter in the digital transformation of cell therapy production.

II. Project Background: The Need for Digital Transformation in the Cell Therapy Industry

As a highly personalized and complex medical technology, cell therapy involves multiple links in its production process, including cell collection, preparation, transportation, and infusion. Each link is crucial to product quality and patient safety. Traditional paper-based records and decentralized management systems are not only inefficient but also prone to issues such as data inconsistency and incomplete records, increasing compliance risks. In addition, the production process of cell therapy products relies heavily on manual operations, making data traceability difficult and failing to meet increasingly stringent regulatory requirements.

Hippocrates’s Cell Therapy Production and Traceability Solution (CGTS) integrates the entire process of cell therapy through digital means, providing a unified digital platform to monitor the production process and supply chain. It helps enterprises avoid compliance risks, improve efficiency, and optimize product quality. The solution includes modules such as Cell Therapy Production Management (CGT), Quality Control (COC), and Cold Chain Transportation Management (COI), covering all links of cell therapy comprehensively.

III. Specific Measures: Advancing the Digital Transformation of Cell Therapy Production in Phases

(1) Overall Planning

Hippocrates’s Cell Therapy Solution has developed a phased digital transformation path for Huadao Biotechnology. Combining the enterprise’s development stage and actual needs, it promotes the digital upgrading of cell therapy production step by step. Through modular configuration, Huadao Biotechnology can flexibly select functional modules suitable for its current development stage, ensuring that cell therapy products meet regulatory requirements while accelerating the speed of product launch.

(2) Business Model Innovation

Through four phases of business planning and digital function implementation, Xingdi’s Cell Therapy Solution helps Huadao Biotechnology free itself from cumbersome manufacturing and supply chain management, focusing on improving the effectiveness and safety of cell therapy drugs. Specific measures include:

End-to-end sample tracking: Realizing end-to-end cold chain transportation tracking from sample collection, transportation, and preparation to infusion through a digital platform, ensuring the quality and safety of cell therapy products.
Digital management of the production process: Achieving digital management of the entire process from raw material receipt, production process monitoring, testing to product release, reducing human errors and optimizing the production process.
Quality control and compliance: Optimizing the production process through data analysis, ensuring data integrity and reliability, and meeting regulatory requirements of domestic and international regulatory markets.
Supply chain optimization: Realizing real-time tracking of cell preparation, transportation, and flow direction through a digital platform, improving the transparency and efficiency of the supply chain.

(3) Technical Architecture

The CGTS Solution is based on Hippocrates’s Aotai Digital Platform. This platform is jointly built by industry experts and IT experts, with the management concept of "Quality Compliance Expert", helping enterprises improve quality management standards and meet industry regulatory requirements. The Aotai Platform has the following characteristics:

Customization capability: Customizing quality systems according to enterprise needs, with built-in configurable tools to support rapid customization of forms, decision trees, and dashboards.
Efficient data management: Adopting a distributed architecture to optimize data storage and access efficiency, supporting rapid loading and analysis of large-volume data.
System integration: Providing a standard intermediate service layer to support seamless integration with third-party systems, enabling data sharing and collaborative work.
Intelligent monitoring and early warning: Through real-time monitoring and early warning functions, reducing the risk of contamination of operation records and ensuring the accuracy, authenticity, and immutability of data.

IV. Construction Achievements: Enhancing the Management Standards of Cell Therapy Production in All Aspects

(1) Internal Enterprise Transformation

End-to-end sample tracking: The digital platform realizes end-to-end cold chain transportation tracking from hospital sample collection to production base preparation, and then to hospital infusion, ensuring the quality and safety of cell therapy products.
Digital management of the production process: Managing the production process of cell therapy products through the digital platform reduces the time and effort spent on material circulation and batch release, and significantly lowers the risk of human errors.
Quality control and compliance: Supporting the analysis of production process data, optimizing the production process, ensuring data integrity and reliability, and complying with regulatory requirements of domestic and international regulatory markets.
Data management and analysis: Providing centralized data management, optimizing R&D processes, and improving the efficiency of production batch management.
Risk control and regulatory burden reduction: Through real-time monitoring throughout the life cycle, reducing the possibility of contamination of operation records and ensuring the accuracy and immutability of data.

(2) Social Achievements

Huadao Biotechnology’s Cell Therapy Production and Traceability Project not only improves the enterprise’s operational efficiency and product quality but also enhances its ability to control complex production processes, meets regulatory requirements, and helps more cell therapy products launch faster. The successful implementation of this project provides valuable experience and a demonstration effect for the digital transformation of the cell therapy industry.

V. Future Outlook: Continuous Innovation to Lead the Digital Transformation of the Cell Therapy Industry

Huadao Biotechnology’s Cell Therapy Production and Traceability Project has laid a solid foundation for the enterprise’s digital transformation. In the future, Huadao Biotechnology will continue to optimize the functions of the CGTS system, introduce more advanced data analysis technologies and tools, and further improve production efficiency and quality management standards. At the same time, the enterprise will explore the integration with other digital solutions to realize refined management of the production process and in-depth integration of enterprise resources.

Through continuous efforts, Huadao Biotechnology will continue to move forward on the path of digital transformation in the cell therapy field, moving towards intelligence and high efficiency. This will not only help the enterprise stand out in the fierce market competition but also provide richer and more valuable experience for the digital transformation of the cell therapy industry, leading the industry towards a more brilliant future.

VI. Related Solutions

Solution 1: Cell Therapy Production and Traceability Digital Solution (CGTS)
Solution 2: GMP Quality Compliance Digital Solution (QMS)

VII. Related Cases

Case 1: Shanghai CARsgen Therapeutics Cell Therapy Production and Traceability Project (CGTS)
Case 2: Zhejiang Zhenyuan Pharmaceutical GMP Quality Compliance Digital (QMS) Project