Chiu Yu-Sung, Wang Kun-Liang, Wu Kun-Lieh
YJ. Biotechnology Co., Ltd., New Taipei City, Taiwan.
Department of Life Science, Fu-Jen Catholic University, New Taipei City, Taiwan.
Front Bioeng Biotechnol. 2025 Sep 3;13:1644318. doi: 10.3389/fbioe.2025.1644318. eCollection 2025.
Cell and extracellular vesicle (EV)-based therapies represent a promising frontier in regenerative medicine and immunotherapy. However, their clinical translation is often constrained by the complexities of Good Manufacturing Practice (GMP)-compliant production, particularly under centralized manufacturing models. This Perspective discusses the emerging role of decentralized, point-of-care (POC) manufacturing in enabling timely, scalable, and patient-specific delivery of cell and EV therapeutics, with a focus on isolator-based systems as core manufacturing infrastructure. We discuss current advances in closed-system technologies, regulatory frameworks, and quality control (QC) strategies supporting GMP compliance in decentralized environments. Real-world applications and case studies illustrate feasibility and translational impact. Isolator-based platforms offer modular, sterile, automation-compatible environments that support both autologous and selected allogeneic product manufacturing at clinical sites. These systems reduce contamination risks, lower facility requirements, and enable integration with real-time QC testing. Despite these advantages, challenges remain, including regulatory ambiguity, workforce training limitations, and quality assurance gaps in decentralized settings. Emerging solutions include automated closed-system bioreactors, digitalized QC workflows, and harmonized operational standards to ensure product safety and consistency. Strategic coordination among regulators, hospitals, and developers will be essential to overcome operational and compliance hurdles. With appropriate infrastructure, skilled personnel, and standardized processes in place, isolator-based POC manufacturing holds the potential to transform how advanced therapies are produced and delivered-ultimately enhancing patient access to safe, effective, and personalized cell and EV-based treatments.
基于细胞和细胞外囊泡（EV）的疗法是再生医学和免疫疗法中一个充满前景的前沿领域。然而，它们的临床转化常常受到符合药品生产质量管理规范（GMP）生产的复杂性的限制，尤其是在集中式生产模式下。本观点文章讨论了分散式即时医疗（POC）制造在实现细胞和EV疗法的及时、可扩展且针对患者的递送方面所发挥的新兴作用，重点关注基于隔离器的系统作为核心制造基础设施。我们讨论了支持分散式环境中符合GMP的封闭系统技术、监管框架和质量控制（QC）策略的当前进展。实际应用和案例研究说明了其可行性和转化影响。基于隔离器的平台提供模块化、无菌且与自动化兼容的环境，支持在临床场所进行自体和选定的异体产品制造。这些系统降低了污染风险，减少了设施要求，并能够与实时QC测试集成。尽管有这些优势，但挑战依然存在，包括监管模糊性、劳动力培训限制以及分散式环境中的质量保证差距。新兴解决方案包括自动化封闭系统生物反应器、数字化QC工作流程以及统一的操作标准，以确保产品安全和一致性。监管机构、医院和开发者之间的战略协调对于克服操作和合规障碍至关重要。有了适当的基础设施、熟练的人员和标准化的流程，基于隔离器的POC制造有潜力改变先进疗法的生产和递送方式，最终增加患者获得安全、有效且个性化的基于细胞和EV的治疗的机会。
