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Related Concept Videos

Three-Compartment Open Model01:06

Three-Compartment Open Model

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The three-compartment open model is a pharmacokinetic model used to describe the distribution and elimination of drugs following extravascular administration. It comprises a central compartment representing the plasma and two peripheral compartments. The highly perfused peripheral compartment represents organs and tissues with a rich blood supply, such as the liver, kidneys, and lungs. The scarcely perfused peripheral compartment represents tissues with lower blood supply, such as adipose...
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Pharmacodynamic Models: Logarithmic Concentration–Effect Model01:15

Pharmacodynamic Models: Logarithmic Concentration–Effect Model

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The log-linear model is a pharmacological framework used to describe the relationship between drug concentration and its effect. This model is particularly relevant when the observed effects range between 20% and 80% of the drug’s maximum effect (Emax), where a near-linear relationship is observed between the log of drug concentration and the measured effect. However, the log-linear model does not predict the maximum possible effect (Emax) or the effect at zero drug concentration,...
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Mechanistic Models: Compartment Models in Individual and Population Analysis01:23

Mechanistic Models: Compartment Models in Individual and Population Analysis

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Mechanistic models are utilized in individual analysis using single-source data, but imperfections arise due to data collection errors, preventing perfect prediction of observed data. The mathematical equation involves known values (Xi), observed concentrations (Ci), measurement errors (εi), model parameters (ϕj), and the related function (ƒi) for i number of values. Different least-squares metrics quantify differences between predicted and observed values. The ordinary least...
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Parameters Affecting Nonlinear Elimination: Zero-Order Input, First-Order Absorption and Two-Compartment Model01:13

Parameters Affecting Nonlinear Elimination: Zero-Order Input, First-Order Absorption and Two-Compartment Model

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Drugs administered through various routes can lead to nonlinear elimination, resulting in complex pharmacokinetic behaviors crucial to understanding efficacious drug dosing.
When a drug is administered through a constant intravenous infusion and eliminated via nonlinear pharmacokinetics, it follows zero-order input. For example, oral drugs undergo first-order absorption upon administration and are eliminated through nonlinear pharmacokinetics.
In the case of subcutaneously administered drugs,...
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Pharmacodynamic Models: Linear Concentration–Effect Model01:15

Pharmacodynamic Models: Linear Concentration–Effect Model

32
The linear concentration–effect model, underpinned by the principle that pharmacological effect (E) is directly proportional to plasma drug concentration (C), emerges as a pivotal simplification of the Emax model for conditions where C is significantly less than EC50. This model portrays a linear trajectory of the concentration–effect relationship when drug levels are markedly below the EC50 threshold.Despite its inherent assumption of continuous effect augmentation with increasing...
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Pharmacodynamic Models: Additive and Proportional Drug Effect Model01:09

Pharmacodynamic Models: Additive and Proportional Drug Effect Model

41
Drug response models describe how pharmacological agents interact with biological systems to produce measurable effects. Baseline responses are inherent physiological activities without a drug significantly influencing the observed pharmacological outcomes. Depending on the drug response model employed, these baseline responses may combine with the drug's effect in either an additive or proportional manner.Additive Drug Response ModelIn the additive model, the drug effect is independent of the...
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Method for Measurement of Viral Fusion Kinetics at the Single Particle Level
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A three plus three parameters mechanistic model for viral filtration.

Prakhar Misra1, Abhishek Sinha1, Anurag S Rathore1

  • 1Dept. of Chemical Engineering, Indian Institute of Technology, Delhi, 110016, India.

Biotechnology Progress
|July 13, 2017
PubMed
Summary

A new six-parameter model simplifies viral filtration in monoclonal antibody production. This mechanistic model accurately predicts filter performance, reducing overdesign and improving process efficiency for biopharmaceutical manufacturing.

Keywords:
LRVflux decaymodelingviral filtration

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Area of Science:

  • Biochemical Engineering
  • Separation Processes
  • Biopharmaceutical Manufacturing

Background:

  • Viral filtration is a critical, costly regulatory step in monoclonal antibody (mAb) downstream processing.
  • Current practices often involve overdesigned filters to manage process variability.
  • Accurate modeling can optimize filter selection and sizing, reducing costs and improving efficiency.

Purpose of the Study:

  • To develop a simple, mechanistic model for viral filtration.
  • To accurately predict filter performance based on membrane and feed characteristics.
  • To provide a tool for optimizing viral filter design and sizing in mAb production.

Main Methods:

  • Proposed a six-parameter mechanistic model for viral filtration.
  • Model considers pore blocking and constriction based on viral particle retention.
  • Validated the model using experimental data from four commercial membranes and model viruses.

Main Results:

  • The model accurately describes viral filter behavior across different membranes and viruses.
  • Parameter analysis reveals mechanisms behind membrane performance variations.
  • Model accurately predicts changes in retention and flux with feed concentration.

Conclusions:

  • The proposed model offers a robust and accurate approach to understanding viral filtration.
  • It can guide the optimization of viral filter design and sizing in biopharmaceutical manufacturing.
  • Implementation can lead to more efficient and cost-effective downstream processing of mAbs.