Colleges of Nanoscale Science and Engineering, SUNY Polytechnic Institute, 257 Fuller Road, Albany, NY 12203, United States.
Curr Opin Biotechnol. 2018 Oct;53:65-75. doi: 10.1016/j.copbio.2017.12.014. Epub 2017 Dec 28.
While the therapeutic biologics are dominated by therapeutic proteins, particularly monoclonal antibodies, a wide range of non-protein therapeutic biologics are rapidly gaining ground both in clinical studies and approved products. Many of these first-in-class therapies provide novel treatment modalities and address previously untreatable conditions or undruggable targets. In particular, novel treatments for rare genetic disorders and qualitatively different oncology therapeutics have been approved in the last two years. This review discusses recent advances in peptide, nucleic acid, carbohydrate, vaccine, and cell-based therapies as well as the manufacturing and commercialization challenges associated with these novel therapeutics.
虽然治疗性生物制剂主要以治疗性蛋白为主,特别是单克隆抗体,但许多新型的非蛋白治疗性生物制剂在临床研究和已批准产品中都迅速得到应用。这些首创疗法中的许多为新的治疗方式,针对的是以前无法治疗的疾病或无法用药的靶点。特别是,过去两年已批准了用于治疗罕见遗传疾病的新型疗法和具有完全不同作用机制的肿瘤治疗药物。本综述讨论了肽、核酸、碳水化合物、疫苗和基于细胞的疗法的最新进展,以及这些新型疗法的制造和商业化面临的挑战。