监管视角下的复杂生物制品生物活性测试
A Regulatory Perspective on Testing of Biological Activity of Complex Biologics.
机构信息
Department of Chemical Engineering, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga, Mumbai 400019, India.
Department of Pharmaceutical Sciences, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga, Mumbai 400019, India.
出版信息
Trends Biotechnol. 2018 Mar;36(3):231-234. doi: 10.1016/j.tibtech.2017.12.004. Epub 2018 Jan 5.
Antibody-drug conjugates (ADCs) and bispecific antibodies are becoming increasingly popular. However, their complex structures mandate stringent regulatory guidelines to ensure their safety and efficacy. We have briefly reviewed the existing regulatory guidelines and presented our perspectives on refining them to hasten the transition of these drugs from laboratories to market.
抗体药物偶联物（ADCs）和双特异性抗体正变得越来越受欢迎。然而，它们复杂的结构需要严格的监管指导方针来确保其安全性和有效性。我们简要回顾了现有的监管指导方针，并提出了我们的观点，即对其进行完善，以加速这些药物从实验室向市场的转变。
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