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基于产品质量分析的中国仓鼠卵巢细胞流加培养工艺的优化

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摘要 在前期建立的流加培养工艺的基础上,考察培养过程中的pH值对流加培养过程的影响,明确了过程控制参数pH值与产品关键质量属性(critical quality attributes,CQAs)间的联系,建立了产物质量属性和过程操作属性间的关系,并确认pH值为抗体融合蛋白生产工艺中的关键控制参数。结果表明,流加培养过程随着培养pH值的提高,抗体融合蛋白的生物学活性呈一定程度的下降趋势,但唾液酸含量却呈明显的上升趋势;此外,在pH值6.9和pH值7.0的条件下培养过程中的最大细胞密度、活力、蛋白表达量均优于其他条件,确定6.95±0.05为过程的控制pH值。将此培养工艺放到大200 L中试生产规模,结果与2 L反应器的结果基本一致。
出处 《江苏农业科学》 北大核心 2015年第4期47-50,共4页 Jiangsu Agricultural Sciences
基金 国家自然科学基金(编号:21106045)
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