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光会加剧Ipilimumab的pH展开引起的局部和全球效应

Elena Rizzotto¹, Ilenia Inciardi¹, Benedetta Fongaro¹

¹Department of Pharmaceutical and Pharmacological Sciences, Via Marzolo 5, 30131 Padova, Italy.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

|June 29, 2024

概括

在病毒失活期间的低pH值可以展现治疗性单克隆抗体 (mAbs). 在这个过程中,暴露于光线会进一步破坏伊皮利穆马布的结构,影响药物的疗效和生产产量.

科学领域:

生物制药制造业生物制药制造业
蛋白质化学蛋白质化学
药物的稳定性药物的稳定性

背景情况:

治疗性单克隆抗体 (mAbs) 对于治疗癌症和自身免疫性疾病至关重要.
在生产过程中,mAbs容易受到pH值变化和光线等压力因素的结构损伤.
病毒无活化是一个关键步骤,涉及低pH值定位,对mAb稳定性构成风险.

研究的目的:

为了研究在低pH值病毒失活期间暴露于光线对Ipilimumab的结构完整性的影响.
为了确定伊皮利木马布脱的pH值值,并了解其重新折叠的能力.
评估光线如何加剧Ipilimumab的pH诱导的结构变化.

主要方法:

伊皮利木马布的生物物理和生物化学特征.
在不同的pH条件下分析结构完整性.
低pH值和暴露于光线的联合影响的评估.

主要成果:

pH 值的变化显著破坏了 ipilimumab 的稳定性,在 pH 2 时导致不可逆转的展开.
伊皮利木马布的变性值在pH值2到3之间,与结构合作性丧失有关.
暴露于光线会加剧局部和全球的结构变化,增加pH暴露区域的脆弱性.

结论:

低pH的病毒失活对mAb的结构完整性和治疗疗效构成重大风险.
在绝育过程中暴露于光线会加剧结构损伤,需要采取预防措施.
优化pH值和考虑光保护对于稳定的mAb生产和维持药物活性至关重要.

关键词:

一个单克隆抗体的抗体.摄影稳定性摄影稳定性蛋白质聚合蛋白质的聚合.蛋白质药物是一种蛋白质药物.蛋白质的碎片化蛋白质的碎片化由pH引起的展开.

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