Dataset Information

Trastuzumab Charge Variants: a Study on Physicochemical and Pharmacokinetic Properties.

ABSTRACT:

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 attribute for the therapeutic mAbs, there is controversy about their direct role in safety and efficacy. In this study, the physicochemical and pharmacokinetic (PK) properties of the separated charge variants belonging to a trastuzumab potential biosimilar, were examined.

Methods

The acidic peaks, basic peaks, and main variants of trastuzumab were separated and enriched by semi-preparative weak cation exchange. A panel of analytical techniques was utilized to characterize the physicochemical properties of these variants. The binding affinity to HER2 and FcγRs 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 monoclonal antibodies, evaluating the effect of their charge variants on efficacy and PK parameters is needed.

SUBMITTER: Torkashvand F

PROVIDER: S-EPMC10314757 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Trastuzumab Charge Variants: a Study on Physicochemical and Pharmacokinetic Properties.

Torkashvand Fatemeh F Mehranfar Mahsa M Rashidi Gero Mahsa M Jafarian Parisa P Mirabzadeh Esmat E Azarian Bahareh B Sardari Soroush S Vaziri Behrouz B

Iranian biomedical journal 20230301 2 & 3

<h4>Background</h4>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 attribute for the therapeutic mAbs, there is controversy about their direct role in safety and efficacy. In this study, the physicochemical and pharmacokinetic (PK) properties of the separated charge variants belonging to a trastuzumab potential biosimilar, were examined.<h4>Methods</h ...[more]

PMID: 37070702

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Dataset Information

Trastuzumab Charge Variants: a Study on Physicochemical and Pharmacokinetic Properties.

Background

Methods

Results

Conclusion

Publications

Trastuzumab Charge Variants: a Study on Physicochemical and Pharmacokinetic Properties.

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