重组单克隆抗体相关物质和相关杂质的研究与评价

Comments on the development and assessment of the drug impurities and substances related to recombinant monoclonal antibodies

重组生物技术制备的单克隆抗体(以下简称重组单抗)是生物制品中一类重要的药物类别。近年来,由于其精确的靶向杀伤和中和等生物学效应,重组单抗在肿瘤、自身免疫性疾病等方面受到了广泛的研究和应用,并且在神经学、眼科学等其他疾病领域的研究也开始逐步发展起来。目前,国内生产的重组单抗主要采用真核细胞培养表达的方法,在工艺研发和质量研究方面,药品企业对主要有效成分的结构研究和质量控制关注较多;但是对产品组成中的杂质和相关物质研究较少或关注度不够。考虑到这些杂质或相关物质是重组单抗产品中的重要组成部分,将会影响到产品的质量、临床应用的安全性和有效性,应在研究中予以重视。本文对重组单克隆抗体产品中相关杂质和相关物质的研究和评价进行了探讨。

Recombinant monoclonal antibodies have been established as a major product class of biotech- nology-derived medicinal products and widely applied in the clinical fields of oncology, autoimmune disease as well as neurology,ophthalmology and so on, due to their precisely targeted biological activates of cytotoxic and neutrali- zing effect in recent years. Nowadays, pharmaceutical enterprises of China usually pay more attention towards the structure and quality control of the main substance produced from eukaryotic cells, rather than the related impurities and substances. However, these impurities and substances are parts of the product components, and may impact on product quality ,clinical safety and effectiveness. Therefore, they should be recognized as equally important as the main substance and be investigated. This article will present comments on the research and evaluation of the related impurities and substances in recombinant monoclonal antibody products.