探索生物制药分析与紧毛细管液体染色学仪器仪表
Benjamin P Libert1, Samuel W Foster1, Elisabeth P Gates2
1Rowan University.
概括
微型液态色谱 (LC) 系统为制药制造提供便携式分析. 携带的LC仪器与质谱学 (MS) 相结合,用于单克隆抗体 (mAb) 鉴定.
科学领域:
- 分析化学 分析化学
- 生物制药学分析
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 分析仪器的小型化是一个日益增长的趋势.
- 便携式液态色谱 (LC) 系统可在现场进行分析,减少样品运输.
- 在现场监测对于制药和生物制药制造至关重要.
研究的目的:
- 描述一个便携式的,小型化的LC仪器.
- 为了证明其在生物制药单克隆抗体 (mAb) 的表征中的应用.
- 要突出便携式LC-MS在制造环境中的实用性.
主要方法:
- 开发和实施一个便携式,小型化的LC系统.
- 将LC系统与质谱仪 (MS) 的合.
- 应用LC-MS系统用于单克隆抗体 (mAb) 的表征.
主要成果:
- 使用便携式LC-MS系统成功对生物制药单克隆抗体 (mAb) 进行了表征.
- 在制造环境中展示现场分析的可行性.
- 验证微型LC技术用于生物制药品质量控制.
结论:
- 便携式小型LC-MS仪器适用于生物制药特征.
- 这些系统提高了灵活性,并使实时流程监控成为可能.
- 该技术支持在制造环境中直接进行高效的质量控制.
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