Developing the Stability of PD-1 / PD-L1 Immune Checkpoint Antibody Drug Formulation

doi:10.13523/j.cb.2005048

China Biotechnology

2020, Vol. 40

Issue (10): 35-42 DOI: 10.13523/j.cb.2005048

Developing the Stability of PD-1 / PD-L1 Immune Checkpoint Antibody Drug Formulation

LIN Jian-hua¹,HAN Jun^2,^*,Xu Han-mei^1,^*

1 China Pharmaceutical University, Nanjing 211198, China
2 Tasly Biopharmaceuticals Co., Ltd., Shanghai 201203, China

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Abstract

Recently, antibody drugs have developed rapidly in the field of biopharmaceuticals. Clinically, the type and number of monoclonal antibody-based tumor therapies are increasing. With confirmed structure of PD-1/PD-L1 protein,monoclonal antibody drugs against immune checkpoint PD-1/PD-L1 have been continuously developed and applied to the treatment of many principal cancers with high mortality and low cure rate. However, due to the complex physical and chemical properties and serious homogenization, monoclonal antibody drugs are necessary to screen out stable protein preparations for clinical applications based on the characteristics of different monoclonal antibody drugs. This article reviews the role of different antibody drug formulations (buffer components, drug excipients), combined with the PD-L1 target, which introduces the stability development of antibody drug formulations and the main points for evaluation of CDE.

Key words： Immune checkpoint PD-1/PD-L1 mAb Formulation Stability

Received: 22 May 2020 Published: 10 November 2020

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Corresponding Authors: Jun HAN,Han-mei Xu

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Cite this article:

LIN Jian-hua,HAN Jun,Xu Han-mei. Developing the Stability of PD-1 / PD-L1 Immune Checkpoint Antibody Drug Formulation. China Biotechnology, 2020, 40(10): 35-42.

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https://manu60.magtech.com.cn/biotech/10.13523/j.cb.2005048 OR https://manu60.magtech.com.cn/biotech/Y2020/V40/I10/35

Fig.1 Structure of Ig and common antibody fragments

Table 1 Summary of major stability-influencing factors

Table 2 Summary of PD-1/PD-L1 commercial mAb preparation


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