Lifetime stability of size exclusion chromatography columns for protein aggregate analysis

2019/04/12   下载量： 6 次

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应用领域 生物产业
检测样本 其他
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Monoclonal antibodies (mAbs) are currently the dominant class of protein therapeutics in the biopharmaceutical industry due to their high specificity to target antigens, long serum half-life in humans, and capabilities for use in the treatment of a wide range of ailments such as inflammatory diseases and cancer. During product expression and purification from host cells, formulation, and storage, mAbs may undergo various degradation processes, which may alter the safety, efficacy, and quality profile of the drug product. Consequently, a number of critical quality attributes (CQAs) must be monitored throughout drug development and production to ensure biotherapeutic substances are suitable for clinical use.

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Monoclonal antibodies (mAbs) are currently the dominant class of protein therapeutics in the biopharmaceutical industry due to their high specificity to target antigens, long serum half-life in humans, and capabilities for use in the treatment of a wide range of ailments such as inflammatory diseases and cancer. During product expression and purification from host cells, formulation, and storage, mAbs may undergo various degradation processes, which may alter the safety, efficacy, and quality profile of the drug product. Consequently, a number of critical quality attributes (CQAs) must be monitored throughout drug development and production to ensure biotherapeutic substances are suitable for clinical use.


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