创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

佘青清, 涂家生, 孙春萌. 高浓度抗体注射剂的黏度和稳定性控制策略[J]. 药学进展, 2023, 47(12): 940-949. DOI: 10.20053/j.issn1001-5094.2023.12.007
引用本文: 佘青清, 涂家生, 孙春萌. 高浓度抗体注射剂的黏度和稳定性控制策略[J]. 药学进展, 2023, 47(12): 940-949. DOI: 10.20053/j.issn1001-5094.2023.12.007
SHE Qingqing, TU Jiasheng, SUN Chunmeng. Viscosity and Stability Control Strategies for Highly Concentrated Antibody Injections[J]. Progress in Pharmaceutical Sciences, 2023, 47(12): 940-949. DOI: 10.20053/j.issn1001-5094.2023.12.007
Citation: SHE Qingqing, TU Jiasheng, SUN Chunmeng. Viscosity and Stability Control Strategies for Highly Concentrated Antibody Injections[J]. Progress in Pharmaceutical Sciences, 2023, 47(12): 940-949. DOI: 10.20053/j.issn1001-5094.2023.12.007

高浓度抗体注射剂的黏度和稳定性控制策略

Viscosity and Stability Control Strategies for Highly Concentrated Antibody Injections

  • 摘要: 随着生物药物的快速发展,药物越来越倾向于以患者友好的形式开发。皮下给药因其能够作为自我注射的给药方式而引起研究者们关注。高黏度和低稳定性是开发可用于皮下给药的高浓度抗体制剂过程中的2个主要挑战,但目前的研究集中于对这2个挑战分别研究解决方案,而未从这二者的相互影响出发,去探寻既能解决高黏度问题又能保持稳定性的解决方案。为了拓宽对高浓度抗体制剂研发主要挑战的认识和理解,以及提供解决高黏度问题的同时保持稳定性的解决思路,综述从蛋白质-蛋白质相互作用的角度,概述了高黏度和低稳定性的原理和内在关系。此外,结合最近的研究进展和已上市的高浓度抗体制剂处方,讨论了可用于降低黏度的同时保持高浓度抗体制剂稳定性的潜在解决方案。

     

    Abstract: With the rapid development of biologics, there is an increasing tendency for drugs to be developed in a patient-friendly manner. Subcutaneous administration has drawn the attention of researchers because of its ability to be used for self-injection. High viscosity and poor stability are two main challenges in the process of developing highly concentrated antibodies that can be used for subcutaneous administration, yet current studies have focused on both challenges separately, without approaching their mutual influence to explore the solution that can address the problem of high viscosity while maintaining stability. To deepen knowledge and comprehension of the main challenges in highly concentrated antibodies, and to find a solution to the problems of high viscosity and poor stability, this review outlines the principles and internal relationship between high viscosity and poor stability from the standpoint of protein-protein interactions. Besides, potential solutions that can reduce viscosity while maintaining stability in highly concentrated antibodies are discussed on the basis of recent research advances and marketed highly concentrated formulations.

     

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