• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Biotechnology Progress >Feasibility of spectral pH measurement during the low-pH virus inactivation step of continuous therapeutic antibody production
【24h】

Feasibility of spectral pH measurement during the low-pH virus inactivation step of continuous therapeutic antibody production

机译：低pH病毒在连续治疗抗体生产中的低pH病毒失活步骤的可行性

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Acidic virus inactivation is commonly used during production of biotherapeutic products to provide virus safety in case of undetected virus contamination. Accurate pH measurement is required to ensure the product pH reaches a virus-inactivating level (typically 3.5-3.7), and a level post-inactivation that is appropriate for later purification steps (typically 5.5-7.5). Duringbatchlow-pH inactivation in discrete tanks, potentiometric glass probes are appropriate for measuring pH. Duringcontinuousinactivation for 2-3 weeks in an enclosed product stream, probe calibration drift and lag may lead to poor accuracy, and operational difficulties when compensating for drift. Monitoring the spectral response of compounds (indicators) in the product stream whose spectra are pH-sensitive offers a possible alternative way to measure pH without these drawbacks. Such indicators can already exist in the stream (intrinsic) or can be added (extrinsic). Herein are reported studies evaluating the feasibility of both.Promising ultraviolet screening results with the two extrinsics studied, thiamine and ascorbic acid, led to the addition of both to product stream samples titrated to different potentiometric pH values in the 3.3-4.5 range (a representative range encountered during continuous inactivation), and attempts to model pH using sample ultraviolet spectra. One model, based on variability in six spectral attributes, was able to predict pH of an independent sample set within +/- 0.07 units at the 95% confidence level. Since a typical inactivating pH tolerance is +/- 0.1 units, the results show that extrinsic indicators potentially can measure inactivation pH with sufficient accuracy. Suggested future steps and an alternative approach are presented.
机译：在生物治疗产品的生产过程中通常使用酸性病毒失活，以便在未检测到的病毒污染的情况下提供病毒安全性。需要精确的pH测量以确保产物pH达到病毒失活水平（通常为3.5-3.7），以及适用于后来纯化步骤的水平后失活的水平（通常为5.5-7.5）。在离散罐中的液位中灭活期间，电位玻璃探针适合测量pH。在封闭的产品流中为2-3周内的过程中发生，探针校准漂移和滞后可能导致准确性差，并且在补偿漂移时的操作困难。监测光谱敏感的产品流中化合物（指示器）的光谱响应，提供了测量pH的可能替代方法，而不会在没有这些缺点的情况下测量pH值。这些指示剂已经存在于流中（内在）或可以添加（外在）。据报道，综述紫外线筛选结果评估了硫胺和抗坏血酸的两种外在筛选结果的研究，导致催化到3.3-4.5范围内（代表性）的不同电位pH值的产物流样品。在连续失活期间遇到的范围），并尝试使用样品紫外光谱进行模型pH。一种模型，基于六个光谱属性的可变性，能够在95％置信水平的95％置信水平下预测+/- 0.07单位内设定的独立样品的pH值。由于典型的灭活pH耐受性是+/- 0.1单位，结果表明，外在指示剂可能会以足够的准确度测量灭活pH。提出了未来的步骤和另一种方法。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号