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<p>An approach for studying the stress stability of medicinal products based on monoclonal antibodies (mAbs) is proposed. The duration of and intensity of exposure to the following stress factors were selected: exposure to light and high temperatures, freezing, mechanical stress, pH shift, and oxidation. Critical quality attributes for monitoring mAbs degradation products were identified. A stress stability study of a medicinal product containing IgG1 mAbs was conducted using the proposed approach.</p>

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Stress Stability of Medicines Based on IgG1 Monoclonal Antibodies

  • 期刊论文

  • 发表日期：

    2025年12月1日

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  • A. M. Ryakhovskaya,
  • V. O. Shitikova,
  • E. A. Lomkova,
  • D. A. Tolstykh,
  • A. A. Sozonova,
  • A. A. Kostandyan

摘要

An approach for studying the stress stability of medicinal products based on monoclonal antibodies (mAbs) is proposed. The duration of and intensity of exposure to the following stress factors were selected: exposure to light and high temperatures, freezing, mechanical stress, pH shift, and oxidation. Critical quality attributes for monitoring mAbs degradation products were identified. A stress stability study of a medicinal product containing IgG1 mAbs was conducted using the proposed approach.