通过高性能离子交换色谱学与脉冲电压计检测相结合,对残留DTT进行量化
Burki Rajendar1, M V N Janardhan Reddy1, Madhavi Adusumilli1
1Research & Development, Biological E Limited, Shameerpet, Hyderabad 500078, India.
概括
一种新的,敏感的方法准确量化了病毒样颗粒 (VLP) 疫苗中的残留滴二醇 (DTT). 这种具有成本效益的技术通过在制造过程中监控有毒的DTT去除,确保VLP安全.
科学领域:
- 生物制药制造业 生物制药制造业
- 分析化学是一种分析化学.
- 疫苗学 疫苗学 疫苗学
背景情况:
- 病毒样颗粒 (VLP) 是更安全的疫苗替代品,但它们的制造涉及有毒的dithiothreitol (DTT).
- 确保完全去除DTT对于VLP疫苗的安全性和有效性至关重要.
- 目前的DTT检测方法复杂,可能缺乏低水平的灵敏度.
研究的目的:
- 开发一种简单,灵敏和具有成本效益的方法,用于量化VLP疫苗中的残留DTT.
- 在疫苗制造过程中建立一个可靠的DTT移除监测工具.
主要方法:
- 采用了高性能阴离子交换色谱与脉冲度检测 (HPAEC-PAD).
- 结合HPAEC-PAD与用于DTT量化的电化学探测器.
- 验证了灵敏度和线性范围的方法.
主要成果:
- 实现了DTT的1到10 ng/mL的线性量化范围.
- 确立了100 pg的量化限制.
- 与现有的光和HPLC-MS方法相比,已证明具有更高的灵敏度和成本效益.
结论:
- 开发的HPAEC-PAD方法为监测VLP疫苗生产中的残留DTT提供了一种优越的方法.
- 这种技术可以应用于任何需要DTT移除监控的产品.
- 确保生物制药制造业的增强安全和质量控制.
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