2024
DOI: 10.30895/2221-996x-2024-24-1-32-45
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Development and validation of an analytical procedure for the determination of residual protein A in active substances of therapeutic monoclonal antibodies

E. V. Nozdrina,
D. A. Mazalev,
D. R. Rogozina
et al.

Abstract: 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 can complicate the immunoenzymatic detection of protein A (matrix effect), potentially leading to false-negative test results. To increase the efficiency of enzyme-linked immunosorbent assay (ELISA), it is necessary… Show more

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