在生物治疗过程流中使用液态染色学三重四极质谱法对残留的奥林丁碳酸的定量分析
Ciaran Buckley1, Ciara MacHale2, Jonathan Bones3
1Eli Lilly Kinsale Limited, Dunderrow, Kinsale, Co. Cork P17 NY71, Ireland; School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, Dublin 4 D04 V1W8, Ireland.
Journal of pharmaceutical and biomedical analysis
|October 21, 2023
概括
奥林特里碳酸 (ATA) 是一种在生物制造中使用的辅助剂. 开发了一种新的LC-MS/MS方法来准确测量残留ATA,确保治疗蛋白的下游加工过程中患者的安全.
科学领域:
- 生物制药制造业 生物制药制造业
- 分析化学 分析化学
- 过程开发 过程开发
背景情况:
- 奥林特里碳酸 (ATA) 是一种辅助剂,在生物治疗生产中增强了中国子卵巢 (CHO) 细胞生长.
- 剩余的ATA可以引起毒理效应,需要在下游加工过程中去除.
- 确保患者安全需要强大的方法来监测ATA清除.
研究的目的:
- 开发和验证一种液体染色学三重四极质谱法 (LC-MS/MS) 方法.
- 在生物治疗药物的下游加工过程中监测ATA的过程清除.
- 为了确保制造控制和患者安全.
主要方法:
- 开发一种LC-MS/MS方法,使用50 × 3mm,3μm的Imtakt Cadenza HS-C18列.
- 在选择的反应监测模式下运行三重四极质谱仪,用于敏感检测.
- 对两种抗体类型 (IgG1,IgG4) 的线性 (62.52000 ng/mL),准确性和精度的验证.
主要成果:
- 开发的LC-MS/MS方法显示了可接受的线性,准确性和精度.
- 分析物的特异性和选择性得到证实,没有干扰的峰值.
- 该方法已成功应用于在触流过 (TFF) 过程中监测ATA清除.
结论:
- 一种经过验证的LC-MS/MS方法可以对ATA进行敏感和特定的监测.
- 这种方法对于确保生物治疗下游加工中的残留ATA去除至关重要.
- 经过验证的方法支持生物制药生产中的制造控制和患者安全.
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