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首页> 外文期刊>Biotechnology Progress >Effect of Cell Culture Medium Components on Color of Formulated Monoclonal Antibody Drug Substance
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Effect of Cell Culture Medium Components on Color of Formulated Monoclonal Antibody Drug Substance

机译：细胞培养基成分对配制的单克隆抗体药物物质颜色的影响

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摘要

As the industry moves toward subcutaneous delivery as a preferred route of drug administration, high drug substance concentrations are becoming the norm for monoclonal antibodies. At such high concentrations, the drug substance may display a more intense color than at the historically lower concentrations. The effect of process conditions and/or changes on color is more readily observed in the higher color, high concentration formulations. Since color is a product quality attribute that needs to be controlled, it is useful to study the impact of process conditions and/or modifications on color. This manuscript summarizes cell culture experiments and reports on findings regarding the effect of various media components that contribute to drug substance color for a specific monoclonal antibody. In this work, lower drug substance color was achieved via optimization of the cell culture medium. Specifically, lowering the concentrations of B-vitamins in the cell culture medium has the effect of reducing color intensity by as much as 25%. In addition, decreasing concentration of iron was also directly correlated color intensity decrease of as much as 37%. It was also shown that the color of the drug substance directly correlates with increased acidic variants, especially when increased iron levels cause increased color. Potential mechanisms that could lead to antibody coloration are briefly discussed.
机译：随着工业朝着皮下递送作为优选的药物施用途径发展，高药物浓度正成为单克隆抗体的标准。在如此高的浓度下，与在历史上较低的浓度下相比，原料药可能显示出更强烈的颜色。在更高颜色，更高浓度的配方中，更容易观察到工艺条件和/或颜色变化的影响。由于颜色是需要控制的产品质量属性，因此研究工艺条件和/或修改对颜色的影响非常有用。该手稿总结了细胞培养实验，并报告了有关各种介质成分影响特定单克隆抗体药物颜色的发现。在这项工作中，通过优化细胞培养基实现了较低的药物颜色。具体地，降低细胞培养基中的B-维生素的浓度具有使颜色强度降低多达25％的效果。另外，铁浓度的降低也与颜色强度降低多达37％直接相关。还显示出原料的颜色与酸性变体的增加直接相关，尤其是当铁含量增加导致颜色增加时。简要讨论了可能导致抗体着色的潜在机制。

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