兽用治疗用单克隆抗体开发及评价要点分析

Veterinary Monoclonal Antibody Development and Evaluation: A Key Points Analysis

关键词:  创新型兽药，兽用治疗用单克隆抗体，药物开发和评价

Key words:  Innovative veterinary medicine  Veterinary monoclonal antibodies  Drug development and evaluation.

摘要:

以治疗用单克隆抗体为代表的治疗用生物制品药物已经成为疾病治疗药物重要组成之一,具有高特异性、多样性、低不良反应率等优点,被广泛应用于癌症、免疫系统疾病、病毒感染性疾病等治疗,取得了良好的临床效果,具有很高的开发价值。目前,兽用治疗用单克隆抗体仍处于研究开发阶段,针对兽用治疗用单克隆抗体开发评价要求和评价方法仍存在大量空白。本综述以欧盟颁布关于非免疫学生物制品开发和评价要求为基础,结合国外已批准上市的兽用治疗用单克隆抗体开发评价过程进行分析,旨在为兽用治疗用单克隆抗体开发和评价提供参考。

Abstract:

Therapeutic monoclonal antibodies, as pivotal components of biological pharmaceuticals, exhibit high specificity, diversity, and a favorable safety profile with low adverse reaction rates. They have been extensively utilized in treating a spectrum of diseases, including cancer, immune disorders, and viral infections, demonstrating promising clinical efficacy and significant development potential. Despite their clinical success, the field of veterinary monoclonal antibodies remains in nascent stages of research and development. There is a notable deficiency in the established evaluation criteria and methodologies for these veterinary therapeutics. This review paper draws upon the European Union"s guidelines for the development and assessment of non-immunogenic biological products to scrutinize the processes involved in the approval of veterinary therapeutic monoclonal antibodies in international markets. The objective is to offer insights and a framework for the advancement and evaluation of monoclonal antibodies intended for veterinary medicine.