de Jorna Romain, Madelaine Isabelle, Larghero Jérôme, Mebarki Miryam
Université de Paris, AP-HP, hôpital Saint-Louis, pharmacie à Usage Intérieur, 1, avenue Claude Vellefaux, 75010 Paris, France.
Université de Paris, AP-HP, hôpital Saint-Louis, unité de Thérapie Cellulaire, porte 15A, 1, avenue Claude Vellefaux, 75010 Paris, France; Université de Paris, AP-HP, hôpital Saint-Louis, centre MEARY de thérapie cellulaire et génique, 1, avenue Claude Vellefaux, 75010 Paris, France; INSERM, centre d'investigation clinique de biothérapies CBT501 et U976, 1, avenue Claude Vellefaux, 75010 Paris, France.
Bull Cancer. 2021 Oct;108(10S):S162-S167. doi: 10.1016/j.bulcan.2021.05.004.
CAR-T cells belong to a new class of biological medicines, referred to as Advanced Therapy Medicinal Products (ATMPs). Despite the cellular component, according to the regulatory definition, CAR-T cells are gene therapy medicines, a sub-category of ATMPs, since their therapeutic effect is the result of their genetic modification. The specificity and the complexity of these innovative drugs have required a complete reorganization of the hospital and pharmaceutical circuits, from the cell collection to the drug administration to the patient. Indeed, increased interaction and collaboration between different healthcare professionals is essential in order to guarantee the quality and safety of these innovative medicines.
嵌合抗原受体T细胞（CAR-T细胞）属于一类新型生物药物，被称为高级治疗药物产品（ATMPs）。尽管其具有细胞成分，但根据监管定义，CAR-T细胞属于基因治疗药物，是ATMPs的一个子类别，因为它们的治疗效果是基因改造的结果。这些创新药物的特异性和复杂性要求从细胞采集到药物给患者使用的整个医院和制药流程进行全面重组。事实上，不同医疗专业人员之间加强互动与合作对于确保这些创新药物的质量和安全性至关重要。
