Drug-loaded erythrocytes: on the road toward marketing approval.
Drug-loaded erythrocytes: on the road toward marketing approval.
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载有药物的红细胞：在营销批准的道路上。
DOI：
10.2147/dddt.s96470
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Godfrin Y
中科院分区：
文献类型：
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作者：
Bourgeaux V;Lanao JM;Bax BE;Godfrin Y
红细胞药物包埋是给药有毒或快速清除药物的最有前景的替代治疗方法之一。载药红细胞可通过三种主要作用机制之一发挥作用：延长循环半衰期(生物反应器)、缓慢药物释放或特定器官靶向。尽管红细胞载体的临床开发面临着监管和开发过程的挑战，但产业发展正在扩大。这类产品的制造可以是集中式的，也可以是基于床边的，并且采用不同的程序来封装治疗剂。成功工业化的主要挑战包括生产可伸缩性、工艺验证和释放的治疗剂的质量控制。讨论了不同制造工艺的优缺点以及临床开发的成功要点。几种基于渗透法的包埋技术已经工业化。公司已经实现了许多关键的临床阶段，从而为未来提供了机会，以涵盖目前尚无有效治疗方法的各种疾病。
Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available.