Zhang Yajie, Williams Iii Robert O, Tucker Haley Oana
Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, United States.
Departments of Bioengineering and Molecular Biosciences, The University of Texas at Austin, Austin, TX 78712, United States.
World J Clin Oncol. 2020 May 24;11(5):275-282. doi: 10.5306/wjco.v11.i5.275.
Development of immunologic-based biopharmaceutical products have strikingly increased in recent years and have made evident contributions to human health. Antibodies are the leading entity in immunotherapy, while chimeric antigen receptor T cells therapies are the advent of a novel strategy in this area. In order to enable antibody candidates or cells available as products, formulation is critical in terms of stabilize molecules or cells to achieve practical shelf life, storage and handling conditions. Here we provide a concise and contemporary review of ongoing formulation strategies and excipients used in approved antibodies and cellular therapeutic products. Excipients are categorized, and their function in formulations are discussed.
近年来,基于免疫学的生物制药产品的开发显著增加,并为人类健康做出了显著贡献。抗体是免疫治疗的主要实体,而嵌合抗原受体T细胞疗法是该领域一种新策略的出现。为了使候选抗体或细胞能够作为产品使用,就稳定分子或细胞以实现实际保质期、储存和处理条件而言,制剂至关重要。在此,我们对已批准的抗体和细胞治疗产品中正在使用的制剂策略和辅料进行了简要而当代的综述。对辅料进行了分类,并讨论了它们在制剂中的功能。