International Symposium on Point-of-Care Manufacturing (POCM) in Cell and Gene Therapy: Regulatory Frameworks and Technical Accessibility Successfully Concludes
On March 28, byMiltenyi Biotec Co., Ltd.withCSGCTCo-organized by,Beijing Haixinyu Urban Renewal Group Co., Ltd.andBeijing Haixing Technology Industry Service Co., Ltd.Co-organizer,Beijing Vital River Laboratory Animal Technology Co., Ltd.、Shanghai Hougao Scientific Instrument Co., Ltd.、Tianjin Tianda Tianfa Technology Co., Ltd.、ShanghaiCityAllBright Law Offices、Shanghai Bixing Law FirmSupport for hosting,Egg Yolk Technology (VCBeat）Hosted by“Point-of-Care Manufacturing for Cell and Gene Therapy (International Symposium Series on POCM Regulations and Technical Accessibility”At Haixing Pharmaceutical and Health Innovation Park, Haidian District, BeijingArea C was successfully held.
Conference Venue
Ms. Ma Min, Senior Manager of the Marketing Department at Miltenyi BiotecServed as the moderator of this seminar.Dr. Yang Zhe, Commercial Director of Miltenyi Biotec ChinaDelivering the opening remarks for the event, he stated that the cell therapy industry is facing the limitations of traditional manufacturing models, with many unmet clinical needs urgently requiring solutions. And The POCM model has introduced new perspectives. Meanwhile, Miltenyi Biotec’s comprehensive technologies and fully closed automated systems offer viable pathways to reduce costs and enhance efficiency. In the future, we will jointly conduct in-depth exploration in regulatory frameworks, technical practices, and business models to achieve technological breakthroughs and commercial sustainability, while also focusing on patient needs and optimization of payment systems.
Dr. Zhe Yang
Miltenyi Biotec China, Commercial Director
Before the official commencement of this seminar,Liu Yan, Head of Industrial Development for the Hai Xinyu Zhongguancun Science City International Medical Valley ProjectThe presentation began with an introduction to Haixinyu Urban Renewal Group, providing a detailed overview of the Haixinyu Pharmaceutical and Health Industrial Park from multiple perspectives, including its five-dimensional integrated business system, layout of the pharmaceutical and health industry, industrial positioning, spatial carriers, and industrial services.
Liu Yan
Head of Industrial Development, Haixin Yu Zhongguancun Science City International Medical Valley Project
During the themed sharing session of this event,Head of Global Regulatory Affairs, Miltenyi BiotecDr. Bernd SchröderFirst, he/she presented the topic “Cell Therapy“Global Regulatory Trends and Collaborative Opportunities in POCM: Driving Industry Innovation and Standardization.” He provided an in-depth analysis of the global development opportunities for cell therapy POCM from perspectives including the current landscape of cell and gene therapy (CGT), key GMP and production considerations, practical case studies, regulatory support, and future trends.
Dr. Bernd Schröder
Head of Global Regulatory Affairs, Miltenyi Biotec
National-Level Drug Inspector、Professor Bi Jun, Chief Expert at the Licensing Review Center of Shenzhen Municipal Administration for Market RegulationHe delivered an insightful presentation titled “In-depth Analysis of the Key Provisions of the Good Manufacturing Practice Guidelines for Cell Therapy Products (Trial).” He provided a detailed explanation of the drafting and key points of guidelines related to cell therapy products, as well as the relevant requirements for pharmaceutical manufacturing, covering aspects such as product definition and scope of application, unique characteristics of product manufacturing and special control measures, biosafety considerations, personnel management, facilities and equipment, and materials and products.
Prof. Jun Bi
National-Level Drug Inspector
Chief Expert, Licensing Review Center of Shenzhen Municipal Administration for Market Regulation
RoundtableDiscussion: From a Global PerspectiveQuality Management for the Full Lifecycle of CGT Products
This timeThe first of the seminarRoundtable Discussion Session with“From a Global PerspectiveQuality Management for the Full Lifecycle of CGT Products” as the theme, Head of Frontier Therapies and Pharmaceuticals at VCBeatLi MengServing as the moderator,Guan Ziqiu, Director of Business Development, Miltenyi Biotec ChinaDr.、Cheng Guoshi, Head of Investment Promotion and Operations, Haixinyu Urban Renewal Group、Liu Tingting, Partner at AllBright Law Offices (Shanghai)、Wang Weibin, Managing Partner of Shanghai Bixing Law Firm、Lin Maojun, Chairman of Watson Crick (Beijing) BiotechnologyFive guests discussed MiltenyiGlobal and regional user support, industry ecosystem enablement, and approved cases for POCM products,The discussion covered topics such as Haixin Yu Urban Renewal Group’s empowerment of pharmaceutical and healthcare enterprises, key points in intellectual property layout and risk prevention for CGT companies, legal support for the globalization of CGT enterprises along with related service cases, and quality management and associated issues for Chinese CGT companies.
Roundtable Live
Assistant Dean, Li Ka Shing Faculty of Medicine, The University of Hong Kong、Director, Department of Pediatrics, The University of Hong Kong-Shenzhen Hospital、Professor Li Peihua, Associate Professor and Consultant in Paediatrics, Queen Mary Hospital, The University of Hong KongDelivered a presentation titled "Patient-Centered Clinical Combination Cell Therapy:“Clinical Practice of POCM.” She discussed the background and objectives of hospital-based cell therapy research, technological platforms and methodologies, clinical application cases of POCM, as well as the implementation and significance of the POCM model. She stated that, through on-site point-of-care manufacturing technology, the POCM model can significantly enhance treatment efficiency and patient survival rates, while reducing treatment costs and further improving clinical outcomes.
Professor Li Peihua
Assistant Dean, Li Ka Shing Faculty of Medicine, The University of Hong Kong
Director, Department of Pediatrics, The University of Hong Kong-Shenzhen Hospital
Associate Professor and Consultant in Paediatrics, Queen Mary Hospital, The University of Hong Kong
Dr. Wang Yongzeng, Chief Technology Officer of Heyuan Biologics"Cell Therapy ProductsHe delivered a presentation titled “Quality Management in the POCM Model: Full-Process Traceability.” He stated that the point-of-care manufacturing (POCM) model for personalized CAR-T cell therapy products presents both advantages and challenges. Implementing POCM in China entails significant demand but also faces a series of issues, including hardware infrastructure, technical requirements, and regulatory approaches. Full-process traceability plays a pivotal role in quality management for point-of-care manufacturing.
Dr. Wang Yongzeng
Chief Technology Officer, Heyuan Biology
Dr. Dong Ao, Investment Manager at Legend Capitalpresented a talk titled "Sharing on “CGT Industry and Investment & Financing Progress.” He provided a detailed analysis of investment and financing, transactional collaborations, product approvals, and R&D progress in the CGT industry from three perspectives: an overview of advanced therapies, updates on CGT industry developments, and becoming an industry investor with financial acumen.
Dr. Ao Dong
Investment Manager, Legend Capital
Global Clinical Protocol Portfolio Strategy Manager, Miltenyi BiotecDr. Cristina Conforti AndreoniDelivered a presentation titled “Medtronic“Global Layout of the POCM Model: International Development Strategies and Innovative Solutions.” She presented successful case studies from Spain (Barcelona), the Netherlands, Canada, and Italy (Milan), where POCM technology has enhanced patient accessibility to cell therapies.
Dr. Cristina Conforti Andreoni
Global Clinical Protocol Portfolio Strategy Manager, Miltenyi Biotec
Cell TherapyPOCM (Point-of-Care Manufacturing) Roundtable
Cell Therapy at This SymposiumPOCM (Point-of-Care Manufacturing) Roundtable Discussion Session“In-depth discussions on the technical requirements, quality management, clinical applications, regulatory perspectives, and global collaboration of POCM aim to promote the standardization, scalability, and sustainable development of cell therapy POCM models.”as the theme,Guan ZiqiuDr.Moderate the roundtable discussion,Dr. Bernd Schröder, Professor Bi Jun, Professor Li Peihua, Dr. Wang Yongzeng, and Dr. Dong AoFive panelists discussed how the regulatory framework for cell therapy products can both ensure safety and foster innovation,How to Construct the Standardized Pathway for the POCM Model from Laboratory to Clinical Practice, and Implement “Patient-Centered” Clinical Translation with “End-to-End Control” for Quality Assurance”、Payment Systems, Market AccessandHow Is the Closed Loop of Capital Exit Formed?offered insightful perspectives on topics such as
Roundtable Live
Thus, thisOn-site Point-of-Care Manufacturing for Cell and Gene Therapy (POCM) International Exchange Seminar Series on Regulations and Technical AccessibilitySuccessfully concluded. This symposium brought together leading enterprises in the global cell preparation systems sector, managers of biopharmaceutical industrial parks, cross-border legal and intellectual property experts, and representatives from innovative industry companies, to jointly discussAn in-depth discussion was held on the regulatory framework, technological innovations, and commercialization pathways of POCM technology. Through the exchange of ideas and intellectual discourse, participants injected new momentum into the global promotion and industrial evolution of POCM technology, while also providing valuable insights for the sustainable development of the global cell and gene therapy (CGT) industry. The successful convening of this symposium marks a further maturation of POCM technology in regulatory and application domains, laying a solid foundation for the construction of a future industrial ecosystem.
"New Opportunities in CGT Venture Capital and Business Development"The forum will be held onThe 2025 VBEF Top 100 Future Healthcare and Pharmaceuticals Exhibition (VBEF), held at the Suzhou International Expo Center on May 10held at, the forum will conduct in-depth discussions on investment and financing, technological upgrades, and industrial synergy in the field of CGT.
The forum features multiple keynote speeches and panel discussions, from ChinaStarting from the underlying development logic of cell and gene therapy (CGT), this event explores topics such as full lifecycle management of innovative drugs, achievement transformation and ecosystem co-creation, and the global expansion of CGT products and their industrial chains. It specially invites the former Director of the Department of Clinical Evaluation for Biological Products at the Center for Drug Evaluation (CDE) of the former National Medical Products Administration (NMPA) to share insights on “Drug Development Thinking: From Laboratory to Clinic.” The event also extends targeted invitations to entrepreneurs, investors, and business development (BD) professionals from large enterprises to facilitate precise matchmaking.
AsAs a key component of the CSGCT series of ecosystem activities, this forum brings together diverse stakeholders—including entrepreneurs, investment institutions, and R&D enterprises—to engage in in-depth industry-academia-research dialogue. It serves to build momentum for the upcoming China Society for Gene and Cell Therapy (CSGCT) Conference and jointly drive innovative development within the industry.
Interested enterprises and industry professionals are welcome to scan the QR code below to register, or add the conference assistant on WeChat for inquiries about event details and content.
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AboutCSCGT
The China Society of Gene & Cell Therapy (CSGCT) is a professional organization in the field of cell and gene therapy in China, dedicated to building a diverse platform for exchange and collaboration that encompasses global research institutions, clinical centers, investors, enterprises, regulatory agencies, patient organizations, and supply chain companies. By fostering synergy among industry, academia, research, application, regulation, and investment, CSGCT aims to break down barriers across the entire lifecycle from basic research to global deployment, address industry challenges, promote sustainable development, help China achieve a globally advanced position in the field of gene and cell therapy, and meet the health needs of patients and the public.
China Cell and Gene Therapy Conference (CSGCT) is the most internationally influential conference in the field of cell and gene therapy in the Asia-Pacific region. In close collaboration with the American Society of Gene & Cell Therapy (ASGCT), it integrates top-tier international resources to introduce cutting-edge scientific advancements, technological applications, market access information, and high-quality collaborative projects from the global cell and gene therapy sector. The conference establishes a platform for in-depth cooperation between China’s industry and the global value chain, promotes the participation of Chinese innovations in the development of global GCT technical standard systems, and jointly builds an internationally aligned mechanism for industrial chain synergy.
The 2nd China Cell and Gene Therapy Conference (CSGCT) in 2025, co-hosted by the CSGCT Organizing Committee, the Beijing Municipal Science and Technology Commission, the People's Government of Haidian District, Beijing, and the Administrative Committee of Zhongguancun Science Park, will be held on September 12–13 at the Zhongguancun Exhibition and Trading Center in Haidian District, Beijing.
