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Purpose <p>Trastuzumab is a humanized monoclonal antibody widely utilized in the treatment of HER2- Positive breast cancer. This study aimed to identify the impurities present in Trastuzumab based on differences in molecular mass and charge variants using SDS-PAGE and ion-exchange chromatography, respectively.</p> Methods <p>SDS-PAGE was employed as a robust analytical technique for the separation and identification of Trastuzumab and its associated impurities. The method was applied to innovator and biosimilar Trastuzumab samples to evaluate the presence of molecular mass-based impurities. Charge variant analysis was carried out using cation-exchange chromatography on a ProPac WCX-10 column coupled with an Ultimate 3000 UPLC system. Trastuzumab-related charge variants were assessed based on their elution profiles.</p> Results <p>In SDS-PAGE, no additional bands were observed in the test samples compared to the corresponding reference standard and innovator’s sample which indicate, an absence of any impurities, suggesting high purity of the sample. The analysis of ion exchange chromatography is based on the criteria that the main peak should comprises at least 50% of the total area, while acidic variants, basic variants and other peaks must constitute not more than 40% of the total peak area.</p> Conclusion <p>The results of the study confirm the biosimilar's purity, structural integrity, and consistency in critical quality attributes, supporting its comparability to the reference and innovator’s product.</p>

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Biosimilarity Evaluation with Respect to the Molecular Masses and Charges Differing from that of Trastuzumab

  • 期刊论文

  • 发表日期：

    2026年4月2日

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  • Rinny Tyagi,
  • Priyanka Chaudhary,
  • Muthusamy Kalaivani,
  • Anubhuti Goyal,
  • Meenakshi Dahiya,
  • Vivekanandan Kalaiselvan

摘要

Purpose

Trastuzumab is a humanized monoclonal antibody widely utilized in the treatment of HER2- Positive breast cancer. This study aimed to identify the impurities present in Trastuzumab based on differences in molecular mass and charge variants using SDS-PAGE and ion-exchange chromatography, respectively.

Methods

SDS-PAGE was employed as a robust analytical technique for the separation and identification of Trastuzumab and its associated impurities. The method was applied to innovator and biosimilar Trastuzumab samples to evaluate the presence of molecular mass-based impurities. Charge variant analysis was carried out using cation-exchange chromatography on a ProPac WCX-10 column coupled with an Ultimate 3000 UPLC system. Trastuzumab-related charge variants were assessed based on their elution profiles.

Results

In SDS-PAGE, no additional bands were observed in the test samples compared to the corresponding reference standard and innovator’s sample which indicate, an absence of any impurities, suggesting high purity of the sample. The analysis of ion exchange chromatography is based on the criteria that the main peak should comprises at least 50% of the total area, while acidic variants, basic variants and other peaks must constitute not more than 40% of the total peak area.

Conclusion

The results of the study confirm the biosimilar's purity, structural integrity, and consistency in critical quality attributes, supporting its comparability to the reference and innovator’s product.