Development and validation of an analytical procedure for the determination of residual protein A in active substances of therapeutic monoclonal antibodies

Development and validation of an analytical procedure for the determination of residual protein A in active substances of therapeutic monoclonal antibodies

SCIENTIFIC RELEVANCE. An important quality-control issue for therapeutic monoclonal antibodies (mAbs) is the determination of residual protein A leaching from the carrier during the purification of mAbs by affinity chromatography. However, unrelated compounds (immunoglobulins) present in the sample...

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Bibliographic Details
Main Authors: E. V. Nozdrina, D. A. Mazalev, D. R. Rogozina, S. P. Zhivoderov, I. V. Lyagoskin, R. R. Shukurov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2024-03-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
protein a
determination of residual protein a
therapeutic monoclonal antibodies
mab
protein a–mab complex
chicken igy immunoglobulins
purification of antibodies by affinity chromatography
immunoenzyme assay
validation of analytical procedures
matrix effect
sample preparation
Online Access:https://www.biopreparations.ru/jour/article/view/558
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