Training Announcement | Standardized System Training Course on Cell Therapy Manufacturing and Clinical Translation
Release Date:
2026-04-10 12:33
The year 2026 marks the inaugural year of the 15th Five-Year Plan for the national economy, and the state attaches great importance to the development of the bioeconomy. Consequently, biologic therapeutic products and clinical treatment technologies centered on cell therapy are poised to enjoy tremendous room for growth. However, with the state’s clear designation of cell therapy products as advanced therapeutic drugs and cutting-edge biomedical technologies, the manufacturing and preparation of such products will inevitably face both substantial opportunities and formidable challenges. Therefore, comprehensively enhancing the quality of cell therapy products, refining manufacturing and preparation protocols, and adopting state-of-the-art production and preparation technologies will become unavoidable, existential challenges for institutions engaged in the manufacturing and preparation of cell therapy products as well as for pilot-scale production facilities involved in the R&D of cell-based therapeutics. In particular, the “Regulations on the Clinical Research and Clinical Translation and Application of New Biomedical Technologies,” promulgated by the State Council in 2025 (hereinafter referred to as Regulation No. 818), and the regulations to be issued in early 2026… Implementing Regulations of the Drug Administration Law of the People’s Republic of China (Hereinafter referred to as Regulation No. 828) further establishes tailored legal regulations specifically for cell therapy products and the manufacturing and preparation of cell-based drugs.
In order to coordinate with the State Council’s “ Regulation No. 818 The implementation of “and” the “Regulations No. 828” has helped cell therapy product and cell-based drug manufacturing and preparation facilities seize opportunities, address challenges, and comprehensively and systematically enhance the compliance standards of existing or planned new such facilities. The Bone Tissue Bank Branch of the China Association for Medical Biotechnology and the Pharmaceutical Cleanroom Technology Branch of the China Association for Medical Biotechnology have jointly organized “ Standardized Systemic Training Course on the Production of Cell Therapy Products and the Clinical Research and Clinical Translation Applications of New Biomedical Technologies ”。
This training program focuses on the regulatory standards governing the manufacturing of cell therapy products and the clinical research and translational applications of new biomedical technologies, attracting participants from enterprises, research institutes, clinical institutions, and industry-chain representatives across the country. Standardization is the fundamental basis for ensuring that these products are safe, effective, and accessible. Hycells As a one-stop upstream cell solutions provider offering primary cells, pharmacological efficacy services, and product services, we look forward to engaging in in-depth exchanges with industry experts and colleagues.
Hycells: Leveraging Product Strength to Support Standardized Implementation
Hycells, with the phrase “ Compliance as the cornerstone, effectiveness as the guiding principle. “will prominently showcase to customers at this conference a comprehensive, benchmark solution for the integrated culture of immune cells and stem cells:”
Compliance First: Ensure strict compliance with industry regulations and ethical standards throughout the entire process to safeguard the project.
Policy Implementation: Conduct in-depth analysis and effective implementation of key industry policies such as the “818” policy, and proactively mitigate compliance risks.
Cost Reduction and Efficiency Improvement: By optimizing the manufacturing process, cost control and efficiency improvements can be achieved while ensuring cell quality and functionality.
Data-driven: Validate the effectiveness of the solution with rigorous experimental data, and highlight the value of our services through authentic customer feedback.
Full support: Providing end-to-end, full-process technical support spanning experimental design, process development, and scale-up to commercial production.
The most significant challenge facing the industry today is the lack of a quality-control system that is both implementable and capable of ensuring traceability and auditability. The value of Hycells lies in helping clients understand the rationale behind regulatory standards and translating that understanding into actionable standard operating procedures for the laboratory. Looking ahead, Hycells will leverage its product strength to underpin the standardized implementation of best practices, continuously advance the research and dissemination of regulatory standards, and help propel the cell therapy industry from “technically feasible” to “clinically reliable and industrially controllable.”
Training Organization
Organizer:
China Association for Medical Biotechnology
Organizing Unit:
Bone Tissue Bank Branch of the China Association for Medical Biotechnology
Pharmaceutical Cleanroom Technology Branch of the China Association for Medical Biotechnology
Co-organizers:
Key Laboratory for Research on Cellular Therapy of Refractory Diseases in Yunnan Province
Shunxi Regenerative Medicine Technology (Kunming) Co., Ltd.
Main Training Content
1. Training on compliance standards related to the manufacturing of cell therapy products, clinical research on new biomedical technologies, and their clinical translation and application
①《 Self-Regulatory Code for Quality Management of Stem Cell Preparation 》CMBA/T005-2016
② “Quality Management Specifications for Cell Banks” CMBA/T006-2017
③ Quality Management Specification for Raw Materials Used in the Production of Cell Therapy Products, CMBA/T00X-2023
④ Technical Code for Cell Preparation Facilities in Hunan Province, DBJ43/T343-2019
⑤ National Standard “Design Code for Cleanrooms for Cell Culture” GB/T 42398-2023
⑥ National Standard “Technical Specification for Cell Culture Operations in Cleanrooms and Controlled Environments” GB/T 43459-2023
⑦ Responsibilities and Key Duties of the Quality Authorization Person in the Production of Cell Therapy Products, Hospital Clinical Research, and Clinical Translation Applications
⑧ Interpretation of Management Measures and Regulations Related to Clinical Research on Cell Therapy
2. Exchange of Learning Insights on the “Administrative Measures for Clinical Research and Clinical Translation Applications of New Biomedical Technologies” and Discussion on Response Strategies for Enterprises and Hospitals
3. Authoritative Report: Discussion on the Development Directions and Pathways of Cell Therapy Products and Emerging Biomedical Technologies
4. Exchange and Discussion on the “Guidance for the Construction of Key Facilities for the Production and Storage of Cell Therapy Products (Draft)”
Main Training Formats
1. Combining expert lectures with on-site Q&A sessions facilitates direct communication between participants and the lecturing experts, thereby deepening participants’ understanding of the relevant statutory provisions.
2. Combining plenary presentations with specialized breakout sessions enables participants to focus on their key concerns, provides more opportunities for them to voice their views, and facilitates the resolution of pressing issues.
3. Combining statutory interpretation with the resolution of practical issues enables participants to obtain, on-site, expert advice and recommendations on solutions to various challenges related to institutional development, renovation, operations, and other areas.
4. Participants serve as both learners and instructors, bringing their own questions to the session and leaving with practical methods to enhance their ability to solve specific problems.
Training Location
Kunming Jiahua Plaza Hotel, Kunming, Yunnan Province
Training Duration
Friday, April 10, 2026 – Sunday, April 12 at noon
Training segment duration
1. A 10.5-hour, 12.6-credit training course on regulatory standards related to the manufacturing of cell therapy products and the clinical research and translational application of new biomedical technologies, featuring live Q&A and interactive discussions.
2. The State Council’s “Regulation No. 818” and “ Regulation No. 828 “Exchange of learning insights and discussion of response strategies: 3.5 hours, equivalent to 4.2 class periods. On-site Q&A and interactive discussions are welcome.”
3. Discussion on the development directions and pathways for cell therapy products and new biomedical technologies, lasting 3 hours (equivalent to 3.6 lecture hours). Participants will have the opportunity to ask questions and engage in face-to-face discussions with experts.
4. “Guidance on the Construction of Key Facilities for the Production and Storage of Cell Therapy Products (Draft)” – a 3.5-hour exchange and seminar, equivalent to 4.2 instructional hours. This session will provide an opportunity for face-to-face questions and discussions with experts on specific issues related to the design, construction, and operation of key facility infrastructure.
Scope of Participation
1. A cell therapy product manufacturing and preparation facility has been established, with an understanding of industry development trends and mastery of the applicable implementation standards for modifying, upgrading, and optimizing production facilities and equipment.
2. When planning to establish a new cell therapy product manufacturing facility or hospital, it is essential to thoroughly understand the relevant construction standards to prevent design and construction defects as well as misjudgments.
3. Hospitals intending to conduct clinical research on new biomedical technologies and their clinical translation applications shall thoroughly familiarize themselves with the selection criteria of the proposed clinical research sponsor institutions and the quality requirements for cell therapy products, thereby ensuring the safety and efficacy of both the clinical research and its clinical translation applications.
4. Management personnel from government regulatory and supervisory authorities should be well-versed in the standards and quality requirements for facilities and equipment used in the manufacturing and preparation of cell therapy products, as well as for clinical research and clinical translation of new biomedical technologies, and for the raw materials used in production. This knowledge will facilitate the rapid development of cell therapy product manufacturing and preparation, and of clinical research and clinical translation of new biomedical technologies in the region through enhanced regulatory services.
5. Personnel from the design, construction, and operation & maintenance entities involved in the cleanroom and controlled-environment facilities for the manufacturing of cell therapy products.
6. Clinical physicians, bedside cell-quality testing personnel, and hospital quality authorization officers at hospitals planning to conduct clinical research on new biomedical technologies and their clinical translation applications shall gain a thorough understanding of the GMP standards for cell manufacturing and the corresponding implementation pathways.
7. Institutions or hospitals planning to construct a pilot-scale cell therapy manufacturing facility—whether they are engaged in cell therapy R&D or have already obtained an Investigational New Drug (IND) approval—should gain a thorough understanding of the relevant construction standards to prevent design and construction defects as well as misinterpretations.
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