Continuous Chromatography Segmentation for High Velocity Binding

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Solution Overview

Problem

Current chromatography methods face challenges in achieving high binding capacities and operational efficiency, particularly in biopharmaceutical purification, where high flow rates reduce binding capacity and increase processing time, limiting productivity.

Innovation Solution

A continuous chromatography method using multiple separation units with specific particle and pore size ranges (30-200 μm and 40-300 nm) and affinity or ion exchange ligands, allowing for continuous flow at velocities above 800 cm/h, enabling high binding capacity utilization and reduced processing time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If high flow rates are used in chromatography, then operational velocity and throughput are improved, but binding capacity is reduced and processing time increases

Engineering Contradiction:
Improveoperational velocityVSAvoidbinding capacity
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The chromatography system is divided into multiple separation units (columns) connected in series, allowing the process to be segmented into multiple binding stages. This enables high flow rates to be maintained while providing sufficient residence time for target molecules to bind to the chromatography matrix through multiple sequential interactions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system operates continuously with feed solution flowing through multiple separation units in sequence, eliminating idle time between batch operations. The continuous flow maintains high operational velocity while the series configuration ensures that target molecules have adequate contact time with the chromatography matrix at each stage, preserving binding capacity.

Inventive Principle:
Principle #20Continuity of useful action

2Productivity

If high flow rates are used in chromatography, then throughput is improved, but processing time increases

Engineering Contradiction:
ImprovethroughputVSAvoidprocessing time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The processing time is segmented across multiple separation units, where each unit handles a portion of the binding process. This allows the overall throughput to increase with higher flow rates while the residence time in each individual unit remains sufficient for effective binding, preventing excessive total processing time.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary binding actions in parallel across multiple separation units simultaneously. While feed solution flows through one unit, other units are already engaged in binding operations, effectively pre-positioning binding capacity to handle incoming flow without increasing overall processing time.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If residence time is reduced to increase productivity, then operational velocity is improved, but binding capacity is compromised

Engineering Contradiction:
Improveoperational velocityVSAvoidbinding capacity
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The binding process is segmented into multiple sequential stages across several separation units. Each unit provides a shorter residence time that is sufficient for partial binding, and the cumulative effect of multiple stages achieves the required overall binding capacity while maintaining high operational velocity through the system.

Inventive Principle:
Principle #1Segmentation

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach significantly increases productivity by maintaining high binding capacities at low residence times, achieving twice the productivity of batch processes with reduced processing time and buffer requirements.

Implementation Method 1

affinity chromatography mode... ProtA modified affinity chromatography support materials to bind and separate the target molecule

Methodology Applied
Scientific EffectAffinity chromatography: Adsorption

Implementation Method 2

ion exchange chromatography modes

Methodology Applied
Scientific EffectIon exchange chromatography: Ion Exchange

Implementation Method 3

pore diffusion are two main parameters, which influence the target molecule diffusivity towards the adsorption sites

Methodology Applied
Scientific EffectPore diffusion: Diffusion

Data Source

PatentEP2841176B1Chromatography method
Publication Date: 2020.12.23 MERCK PATENT GMBH
  • EP2841176B1 patent drawingFigure 1
  • EP2841176B1 patent drawingFigure 2a
  • EP2841176B1 patent drawingFigure 2b

AI summary

The present invention is directed to a continuous affinity chromatography method and to an apparatus to be used in such method. The method allows the use of high operational velocity while maintaining high binding capacities.