Trastuzumab Charge Variants: a Study on Physicochemical and Pharmacokinetic Properties

被引：0

作者：

Torkashvand, Fatemeh ^{[1
]}

Mehranfar, Mahsa ^{[1
]}

Gero, Mahsa Rashidi ^{[1
,2
]}

Jafarian, Parisa ^{[1
,3
]}

Mirabzadeh, Esmat ^{[1
]}

Azarian, Bahareh ^{[1
]}

Sardari, Soroush ^{[1
]}

Vaziri, Behrouz ^{[1
,4
]}

机构：

[1] Pasteur Inst Iran, Biotechnol Res Ctr, Tehran, Iran

[2] Islamic Azad Univ, Dept Biol, Sci & Res Branch, Tehran, Iran

[3] Islamic Azad Univ, Fac Biol Sci, Dept Biochem, North Tehra branch, Tehran, Iran

[4] Pasteur Inst Iran, Biotechnol Res Ctr, 69,Pasteur St, Tehran 1316943551, Iran

来源：

IRANIAN BIOMEDICAL JOURNAL | 2023年 / 27卷 / 2-3期

关键词：

Monoclonal antibodies; Pharmacokinetics; Trastuzumab; MONOCLONAL-ANTIBODIES; IN-VITRO; HETEROGENEITY; RECOMBINANT; BINDING; IDENTIFICATION; DEAMIDATION;

D O I：

暂无

中图分类号：

R318 [生物医学工程];

学科分类号：

0831 ;

摘要：

Background: Post-translational modifications in bioprocessing and storage of recombinant mAbs are the main sources of charge variants. While the profile of these kinds of variants is considered an important quality attribute of therapeutic mAbs, there is controversy about their direct role on safety and efficacy. In this study, the physicochemical and PK properties of separated charge variants belonging to a trastuzumab potential biosimilar were examined.Methods: The APs, BPs, and main variants of trastuzumab were separated and enriched by semi-preparative WCX. A panel of analytical techniques was utilized to characterize the physicochemical properties of these variants. The binding affinity to HER2 and Fc gamma Rs and the PK parameters were evaluated for each variant.Results: Based on the results, the charge variants of the proposed biosimilar had no significant influence on the examined efficacy and PK parameters.Conclusion: During the development and production of biosimilar mAbs, studying the effects of their charge variants on efficacy and PK parameters is needed. DOI: 10.52547/ibj.3837

引用

页码：108 / 116

页数：9

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