Chimeric antigen receptor (CAR)-T cell products, classified as Advanced Therapy Medicinal Products (ATMPs), have shown promising outcomes in cancer immunotherapy. The quality of raw and starting materials used in manufacturing is critical to ensure the efficacy and safety of CAR-T cell products and depends primarily on the selection of the right materials and the right suppliers. It is essential to consider a long-term strategy when selecting raw and starting materials to prevent delays in the supply of innovative, high-quality, and safe therapies to patients. A thorough assessment will allow developers not only to select suppliers who comply with regulatory requirements but also to ensure a sustainable supply of materials throughout the development and the commercial phases. A careful selection of materials and suppliers can avoid the need of comparability studies due to changes in the supply of materials, impacting costs and causing significant delays in development and treatment readiness for patients. This work, coordinated by the T2EVOLVE IMI consortium, provides guidance for the selection and handling of raw and starting materials. By following these suggestions, developers can ensure that they use high quality raw and starting materials through the product development and life cycle, resulting in safe and effective CAR-T therapies for patients.

中文翻译：

---

优化 CAR-T 处理：原材料和起始材料选择T2EVOLVE指南


嵌合抗原受体 （CAR）-T 细胞产品被归类为先进疗法药品 （ATMP），在癌症免疫治疗中显示出有希望的结果。制造中使用的原材料和起始材料的质量对于确保 CAR-T 细胞产品的功效和安全性至关重要，主要取决于选择合适的材料和合适的供应商。在选择原材料和起始材料时，必须考虑长期策略，以防止延迟向患者提供创新、高质量和安全的疗法。全面的评估将使开发商不仅可以选择符合监管要求的供应商，还可以确保在整个开发和商业阶段的可持续材料供应。仔细选择材料和供应商可以避免因材料供应变化而进行可比性研究的需要，从而影响成本并导致患者开发和治疗准备的严重延迟。这项工作由 T2EVOLVE IMI 联盟协调，为原材料和起始材料的选择和处理提供指导。通过遵循这些建议，开发人员可以确保他们在整个产品开发和生命周期中使用高质量的原材料和起始材料，从而为患者提供安全有效的 CAR-T 疗法。