Department of Biotechnology Development, Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary.
Department of Biotechnology Development, Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary.
Drug Discov Today Technol. 2020 Dec;37:31-40. doi: 10.1016/j.ddtec.2020.08.005. Epub 2020 Nov 24.
High concentration monoclonal antibody drug products represent a special segment of biopharmaceuticals. In contrast to other monoclonal antibody products, high concentration monoclonal antibodies are injected subcutaneously helping increase patient compliance and reduce the number of hospital patient visits. It is important to note that a high protein concentration (≥50 mg/mL) poses a challenge from a product development perspective. Colloidal properties, physical and chemical protein stability should be considered during formulation, primary packaging and manufacturing process development as well as optimization of other dosage form-related parameters. The aim of such development work is to obtain a drug product capable of maintaining appropriate protein structure throughout its shelf-life and ensure proper and accurate dosage upon administration.
高浓度单克隆抗体药物产品代表了生物制药的一个特殊领域。与其他单克隆抗体产品不同，高浓度单克隆抗体通过皮下注射给药，有助于提高患者的依从性并减少患者去医院的次数。需要注意的是，高浓度（≥50mg/mL）会给产品开发带来挑战。在制剂、初级包装和制造工艺开发以及优化其他剂型相关参数的过程中，应考虑胶体性质、物理化学蛋白稳定性。此类开发工作的目的是获得一种能够在整个货架期内保持适当蛋白质结构的药物产品，并确保在给药时能够进行准确的给药。
