抗病毒抗体药物研发和药学评价浅析

Considerations on CMC research and evaluation of anti-viral antibodies

抗体药物作为治疗和预防病毒感染的重要手段,临床上已应用于多种病毒感染性疾病的治疗和预防当中。本文总结了靶向病毒的抗体药物相关法规和最新的研究进展,围绕表位和广谱性研究、质量研究与控制等方面对此类产品的药学研究与评价的关注点展开讨论,供业界和监管机构探讨交流,以期能促进此类产品的临床转化和应用。

Antibodies,as an important tool for treatment and prevention of viral infection,have been applied to the treatment and prophylaxis of viral infectious diseases.This article summarized the latest research progress in antibody products that target viruses,and discussed some quality assessment concerns in epitope mapping,neutralization spectrum evaluation,and quality control,expecting to promote the clinical transformation and application of such products.