使用机械建模的染色树脂的概率压力流操作空间
Chris A Gerberich1, Chaoying Ding1, Lee Bink1
1Biopharm Drug Substance Development, GSK, King of Prussia, PA 19406, US.
Journal of chromatography. A
|December 31, 2024
概括
一个新的机械模型预测了色谱列中的压力下降,有助于选择用于生物处理的小珠树脂. 该模型使用力量平衡和小规模数据来预测大规模性能,确保安全的操作范围.
科学领域:
- 化学工程是化学工程的重要组成部分.
- 生物制药制造业 生物制药制造业
背景情况:
- 压力下降是色谱柱性能的一个关键因素,受柱径和树脂特性的影响.
- 对生物处理的小珠树脂的最新进展需要重新关注压力下降预测.
- 传统方法通常需要大量的大规模数据,限制预测能力.
研究的目的:
- 开发和验证一种机械模型,用于预测各种尺度的染色体列的压力下降.
- 为了使用最小的实验数据,准确预测压力流动的行为.
- 建立涉及各种树脂的染色学过程的安全操作参数.
主要方法:
- 基于力平衡的机械模型被开发出来,用于预测压力下降.
- 小规模实验被用于模型校准.
- 模型的预测得到了验证,并与Phenyl Sepharose 6 FF和其他七种树脂的实验数据进行了对比.
- 根据压力极限和工艺可变性确定了概率运行空间.
主要成果:
- 该模型表明预测和实验压力流量数据之间存在很强的一致性.
- 通过小规模实验进行校准,可以准确预测大规模性能.
- 为多种树脂建立了床高度,流体速度和粘度的安全操作范围.
结论:
- 开发的机械模型有效地预测了跨尺度的压力下降,促进了树脂选择.
- 这种方法允许在过程开发之前早期识别潜在的压力流量问题.
- 该模型支持设置最佳流速范围,即使在色谱序列期间溶液粘度发生变化.
相关概念视频
High-Performance Liquid Chromatography: Elution Process
419
In High-Performance Liquid Chromatography (HPLC), the elution process is critical to the separation of analytes and the quality of chromatographic results. Elution describes how compounds move through the column and separate based on their interactions with the mobile and stationary phases. This process determines the resolution, peak shape, and retention times in the chromatogram, which are essential for identifying and quantifying components in complex mixtures. Understanding the elution...
419
Optimizing Chromatographic Separations
340
Optimizing chromatographic separations is crucial for obtaining clean separations in a minimum amount of time. Optimization is required for several factors, including kinetic effects related to band broadening, plate height, capacity factor, and separation factor.
Band broadening refers to spreading solute bands as they travel through the column. This broadening can impact resolution. Plate height (H) represents the length required for one theoretical plate. A lower plate height corresponds to...
Band broadening refers to spreading solute bands as they travel through the column. This broadening can impact resolution. Plate height (H) represents the length required for one theoretical plate. A lower plate height corresponds to...
340
Column Efficiency: Rate Theory
273
The rate theory of chromatography provides quantitative insight into the shapes and widths of elution bands. These bands are based on the random-walk mechanism governing molecular migration within a column. The Gaussian profile of chromatographic bands arises from the cumulative effect of random molecular motions as they progress through the column.
During elution, a solute molecule experiences numerous transitions between stationary and mobile phases, exhibiting irregular residence times in...
During elution, a solute molecule experiences numerous transitions between stationary and mobile phases, exhibiting irregular residence times in...
273
Chromatographic Resolution
407
In chromatography, a solute moves through a chromatographic column and tends to spread, forming a Gaussian-shaped band. The longer the solute spends in the column, the broader the band becomes. The broadening can lead to overlaps within the column, affecting separation effectiveness.
The effectiveness of separation can be evaluated by determining the level of separation between two neighboring peaks in a chromatogram, which represents the individual components of a sample.
In chromatography,...
The effectiveness of separation can be evaluated by determining the level of separation between two neighboring peaks in a chromatogram, which represents the individual components of a sample.
In chromatography,...
407
High-Performance Liquid Chromatography: Introduction
1.5K
High-performance liquid chromatography(HPLC), formerly referred to as High-pressure liquid chromatography, is a powerful technique used to separate, identify, and quantify components in complex mixtures. The term "high pressure" refers to using high pressure to push the liquid mobile phase through the tightly packed columns.
In HPLC, two phases play a critical role in the separation process:
In HPLC, two phases play a critical role in the separation process:
1.5K
High-Performance Liquid Chromatography: Instrumentation
1.3K
High-performance liquid chromatography, or HPLC, is an analytical technique that separates liquid samples under high pressures. An HPLC instrument consists of glass bottles for storing solvents called mobile phase reservoirs. HPLC-grade solvents are used to maintain high purity, and the dissolved gases are removed using a degasser, such as a vacuum pumping system or sparging with helium. The solvents are then pumped into the analytical column using a screw-driven syringe or reciprocating pumps.
1.3K


