在疏水性相互作用色谱树脂上建模单克隆抗体的行为
Douglas Nolan1, Thomas R Chin2, Mick Eamsureya3
1Takeda Pharmaceuticals America Inc, Lexington, MA, 02421, USA. Douglas.Nolan@takeda.com.
Bioresources and bioprocessing
|April 22, 2024
概括
使用疏水性相互作用染色学 (HIC) 开发单克隆抗体 (mAb) 净化预测模型可以显著加快工艺开发并确保药物安全.
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
- 染色体学 染色体学 是一种染色学.
背景情况:
- 单克隆抗体 (mAbs) 需要高纯度才能安全使用.
- 高分子量 (HMW) 物种是mAb疗法中常见的杂质.
- 疏水相互作用色谱 (HIC) 对于去除HMW杂质至关重要,但树脂选择具有挑战性.
研究的目的:
- 在HIC树脂上开发mAb染色学行为的预测模型.
- 为了确定影响mAb-HIC树脂相互作用的关键参数.
- 为了加快HMW杂质清除的HIC树脂的选择.
主要方法:
- 在13种HIC树脂中模拟了7mAbs的染色学行为.
- 使用的mAb表面疏水性,电荷,热稳定性和树脂疏水性/泽塔潜力.
- 实现了高型号合适质量 (调整R2>0.80).
主要成果:
- 确定了泽塔电位作为一种新的关键建模参数.
- 通过使用开发的模型,成功预测了HMW清除和恢复.
- 实现了60%的HMW清除和89%的恢复测试mAb.
结论:
- 开发的预测模型可以显著加快HIC树脂选择mAb净化.
- 这些模型有助于在生物制药行业更快的下游工艺开发.
- 这种方法提高了效率,并减少了 mAb 流程优化所需的时间和资源.
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