实施机器学习工具,用于对工艺染色学单元运行过程的持续过程验证.
Anupa Anupa1, Naveen G Jesubalan1, Rishika Trivedi2
1School of Interdisciplinary Research, Indian Institute of Technology Delhi, New Delhi, India.
Journal of chromatography. A
|January 8, 2025
概括
本研究介绍了在生物制药制造中使用先进分析技术进行持续过程验证 (CPV) 的策略. 它展示了实时监测和控制阴离子交换染色学,确保产品质量的一致性,并使工业4.0的采用.
科学领域:
- 生物制药制造业 生物制药制造业
- 过程分析技术 (PAT) 是一种分析技术.
- 工业4.0 工业4.0 工业4.0 工业4.0 工业4.0 是一个
背景情况:
- 生物制药行业正在整合工业4.0技术,由AI和ML驱动.
- 美国FDA的指导方针规定了三阶段的过程验证:设计,合格和持续过程验证 (CPV).
- 实施CPV对于确保持续的生物制药生产质量至关重要.
研究的目的:
- 提出并展示一种在阴离子交换染色学 (CEX) 中实现CPV的策略.
- 为了利用实时数据分析进行流程监控和控制.
- 促进生物制药行业向工业4.0的过渡.
主要方法:
- 使用统计过程控制 (SPC) 图表,从内置传感器 (pH,导电率,紫外线,压力) 获得实时数据.
- 综合拉曼光谱和近红外 (NIR) 光谱用于关键质量属性 (CQA),如电荷变量组成和度.
- 开发了一个基于Python的实时数据分析和偏差响应程序,包括用于PAT工具的深度神经网络 (DNN) 模型.
主要成果:
- 为NIR和拉曼光谱学开发的PAT模型实现了R2值>0.90,表明了统计学意义.
- 通过使用拉曼光谱来证明CEX化物电荷变体组成的控制策略.
- 在CEX负载的故意扰动导致一致的负载变体组成 (酸性~20%,主要~62%,基本~18%).
结论:
- 先进的数据分析,软传感器和适当的分析器使有效的CPV成为可能.
- 拟议的战略支持生物制药行业实施工业4.0.
- 实时监测和控制CEX操作,确保产品质量和工艺稳定性的一致性.
关键词:
人工智能 (AI) 是一种人工智能.阴离子交换色谱学 阴离子交换色谱学持续过程验证 (CPV)深度神经网络 (DNN) 是一个深度神经网络.机器学习 (ML) 是指机器学习.单克隆抗体是一种单克隆抗体.更多相关视频
10:14Chromatographic Fingerprinting by Template Matching for Data Collected by Comprehensive Two-Dimensional Gas Chromatography
Published on: September 2, 2020
4.9K
08:56Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry
Published on: November 22, 2024
556
相关概念视频
00:57High-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
01:11High-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
01:05High-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
01:15Data Validation
141
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
Key parameters for method validation include:
141
01:18Chromatographic Methods: Terminology
1.6K
Chromatography is an analytical technique widely used in fields such as chemistry, biology, environmental science, and pharmaceuticals to separate the components of a mixture and identify substances between them. The process of chromatography is based on the interactions between two distinct phases: the stationary phase and the mobile phase. The stationary phase is fixed in place by a supporting material, while the mobile phase moves over it, carrying the solutes. As the mobile phase travels,...
1.6K
01:13Principles Of Column Chromatography
6.6K
The chromatography technique was first invented in 1901 by Michael S. Tswett, a Russian botanist, to separate plant pigments using organic solvents. Further, in 1941, Archer John Porter Martin and R. L. M. Synge modified the technique by packing silica gel into a column. A mixture of amino acids was then separated on the packed column using chloroform and water mixture as the mobile phase. This was the first report on column chromatography. At present, column chromatography is a widely used...
6.6K