Laurent Alexis, Hirt-Burri Nathalie, Scaletta Corinne, Michetti Murielle, de Buys Roessingh Anthony S, Raffoul Wassim, Applegate Lee Ann
Regenerative Therapy Unit, Lausanne University Hospital, University of Lausanne, Épalinges, Switzerland.
Tec-Pharma SA, Bercher, Switzerland.
Front Bioeng Biotechnol. 2020 Oct 23;8:557758. doi: 10.3389/fbioe.2020.557758. eCollection 2020.
Safety, quality, and regulatory-driven iterative optimization of therapeutic cell source selection has constituted the core developmental bedrock for primary fetal progenitor cell (FPC) therapy in Switzerland throughout three decades. Customized Fetal Transplantation Programs were pragmatically devised as straightforward workflows for tissue procurement, traceability maximization, safety, consistency, and robustness of cultured progeny cellular materials. Whole-cell bioprocessing standardization has provided plethoric insights into the adequate conjugation of modern biotechnological advances with current restraining legislative, ethical, and regulatory frameworks. Pioneer translational advances in cutaneous and musculoskeletal regenerative medicine continuously demonstrate the therapeutic potential of FPCs. Extensive technical and clinical hindsight was gathered by managing pediatric burns and geriatric ulcers in Switzerland. Concomitant industrial transposition of dermal FPC banking, following good manufacturing practices, demonstrated the extensive potential of their therapeutic value. Furthermore, , exponential revalorization of Swiss FPC technology may be achieved the renewal of integrative model frameworks. Consideration of both longitudinal and transversal aspects of simultaneous fetal tissue differential processing allows for a better understanding of the -infinite expansion potential within multi-tiered primary FPC banking. Multiple fetal tissues (e.g., skin, cartilage, tendon, muscle, bone, lung) may be simultaneously harvested and processed for adherent cell cultures, establishing a unique model for sustainable therapeutic cellular material supply chains. Here, we integrated fundamental, preclinical, clinical, and industrial developments embodying the scientific advances supported by Swiss FPC banking and we focused on advances made to date for FPCs that may be derived from a single organ donation. A renewed model of single organ donation bioprocessing is proposed, achieving sustained standards and potential production of billions of affordable and efficient therapeutic doses. Thereby, the aim is to validate the core therapeutic value proposition, to increase awareness and use of standardized protocols for translational regenerative medicine, potentially impacting millions of patients suffering from cutaneous and musculoskeletal diseases. Alternative applications of FPC banking include biopharmaceutical therapeutic product manufacturing, thereby indirectly and synergistically enhancing the power of modern therapeutic armamentariums. It is hypothesized that a single qualifying fetal organ donation is sufficient to sustain decades of scientific, medical, and industrial developments, as technological optimization and standardization enable high efficiency.
在过去三十年里，基于安全性、质量和监管要求对治疗性细胞来源选择进行的迭代优化，构成了瑞士原发性胎儿祖细胞（FPC）治疗核心发展的基石。定制化胎儿移植计划被切实设计为组织采集、最大化可追溯性、培养后代细胞材料的安全性、一致性和稳健性的直接工作流程。全细胞生物处理标准化为现代生物技术进步与当前具有限制作用的立法、伦理和监管框架的充分结合提供了丰富的见解。皮肤和肌肉骨骼再生医学领域的开创性转化进展不断证明FPC的治疗潜力。瑞士通过处理小儿烧伤和老年溃疡积累了广泛的技术和临床经验。按照良好生产规范进行的皮肤FPC库的工业转化，证明了其治疗价值的巨大潜力。此外，瑞士FPC技术的指数级重新评估可通过整合模型框架的更新来实现。同时考虑胎儿组织差异处理的纵向和横向方面，有助于更好地理解多层原发性FPC库中的无限扩展潜力。多个胎儿组织（如皮肤、软骨、肌腱、肌肉、骨骼、肺）可同时采集并用于贴壁细胞培养处理，建立可持续治疗性细胞材料供应链的独特模型。在此，我们整合了体现瑞士FPC库支持的科学进展的基础、临床前、临床和工业发展，并专注于迄今为止从单一器官捐赠获得的FPC的进展。提出了一种单一器官捐赠生物处理的更新模型，以实现持续的标准和数十亿剂负担得起且高效的治疗剂量的潜在生产。因此，目标是验证核心治疗价值主张，提高对转化再生医学标准化方案的认识和使用，可能影响数百万患有皮肤和肌肉骨骼疾病的患者。FPC库的其他应用包括生物制药治疗产品制造，从而间接并协同增强现代治疗手段的力量。据推测，一次合格的胎儿器官捐赠足以维持数十年的科学、医学和工业发展，因为技术优化和标准化可实现高效率。
