生物制药生产的控制策略通过模型预测控制.
Touraj Eslami1,2,3, Alois Jungbauer1,2
1Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna, Austria.
Biotechnology progress
|January 10, 2024
概括
模型预测控制 (MPC) 为生物制药生产提供先进的优化,提高产品产量和工艺完整性. 本综述探讨了MPC应用,为生物技术专家和工程师提供了应对复杂生物处理挑战的工具.
科学领域:
- 生物制药制造业 生物制药制造业
- 工艺控制工程 工艺控制工程
- 实现自动化和优化
背景情况:
- 生物制药行业面临着日益复杂的生产过程.
- 对于先进技术的需求日益增长,以确保产品产量和工艺完整性的一致性.
- 模型预测控制 (MPC) 被认为是应对这些挑战的关键技术.
研究的目的:
- 为生物制药制造中的模型预测控制 (MPC) 应用提供全面的审查.
- 突出MPC在优化复杂的生产流程和确保产品质量的作用.
- 为生物技术专家和工艺工程师提供有关利用MPC进行增强生物处理的见解.
主要方法:
- 对生物制药生产中MPC的现有文献和案例研究的审查.
- 探索各种MPC策略,包括稳定和随机控制.
- 分析MPC与过程分析技术 (PAT) 的集成,以实时监控和控制.
主要成果:
- MPC显示了优化生物制药运营的巨大潜力,从而提高了效率和产品的一致性.
- 将MPC与PAT集成,可以实时进行流程调整,增强控制和维护流程完整性.
- 确定了MPC的各种应用,从基本的稳定控制到先进的随机模型预测控制.
结论:
- 模型预测控制 (MPC) 是一种强大而通用的工具,用于导航现代生物制药制造的复杂性.
- 利用MPC能力可以在流程优化,产量一致性和整体生产效率方面取得重大进展.
- 本综述为实施MPC提供了路线图,使专业人士能够充分发挥其在生物处理中的潜力.
相关概念视频
Pharmacokinetic Models: Overview
701
Pharmacokinetic models utilize mathematical analysis to achieve a detailed quantitative understanding of a drug's life cycle within the body. They are instrumental in simulating a drug's pharmacokinetic parameters, predicting drug concentrations over time, optimizing dosage regimens, linking concentrations with pharmacologic activity, and estimating potential toxicity.
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
701
Pharmacokinetic Models: Comparison and Selection Criterion
74
Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
74
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
129
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
129
Analysis of Population Pharmacokinetic Data
263
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
263
Physiological Pharmacokinetic Models: Assumption with Protein Binding
45
Physiological models with protein binding in pharmacokinetics offer a sophisticated approach to understanding drug disposition. These models consider drug-protein interactions, enabling them to effectively predict drug concentrations in different organs and tissues. This precision aids in accurate drug dosing, providing a significant advantage over conventional models. A key process within these models is equilibration, which ensures that drug concentrations achieve a steady state within the...
45
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models
69
Pharmacokinetic models are mathematical constructs that represent and predict the time course of drug concentrations in the body, providing meaningful pharmacokinetic parameters. These models are categorized into compartment, physiological, and distributed parameter models.
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
69


