Modular Helical Incubation Chamber for Continuous Virus Inactivation

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Solution Overview

Problem

Current biopharmaceutical processes for therapeutic protein purification, particularly monoclonal antibodies, face challenges in achieving efficient viral inactivation with rigid systems that are not adaptable to varying production needs, leading to bottlenecks in continuous processing and potential product damage from prolonged low pH exposure.

Innovation Solution

A modular incubation chamber with a helical coil design that allows for flexible configuration of residence times and flow rates, enabling continuous or semi-continuous virus inactivation with narrow Residence Time Distribution (RTD), facilitating inline processing and minimizing manual adjustments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a static holding tank is used for virus inactivation, then complete virus inactivation is achieved, but processing time is extended and continuous processing is hindered

Engineering Contradiction:

Improvevirus inactivation efficacyVSAvoidprocessing speed

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent transforms the static holding tank system into a dynamic continuous flow system. The incubation chamber allows fluid to continuously flow through a defined path while maintaining inactivation conditions, replacing the batch-mode static hold with a dynamic continuous process that achieves both efficacy and productivity

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent implements continuous virus inactivation by maintaining constant flow through the incubation chamber with controlled residence time. This eliminates the batch processing interruptions and allows continuous productive operation while maintaining complete virus inactivation through proper residence time design

Inventive Principle:

Principle #20Continuity of useful action

2Reliability

If a rigid virus inactivation system is used, then protocol compliance is ensured, but adaptability to varying production needs is reduced

Engineering Contradiction:

Improveprotocol complianceVSAvoidflexibility in residence time and flow rate

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The system incorporates adjustable flow rates and modular incubation chambers that can be configured to achieve different residence times. This dynamic design allows the system to adapt to varying production requirements while maintaining protocol compliance through controlled parameters

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The virus inactivation system is divided into modular incubation chambers that can be individually configured and combined. This segmentation allows flexible arrangement to meet different production needs while each module maintains controlled conditions for protocol compliance

Inventive Principle:

Principle #1Segmentation

3Reliability

If extended incubation time is used for virus inactivation, then complete virus kill is achieved, but product damage from prolonged low pH exposure increases

Engineering Contradiction:

Improvevirus inactivation completenessVSAvoidproduct damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system precisely controls the residence time parameter and pH exposure duration through regulated flow rates. By optimizing these parameters, the system achieves complete virus inactivation within the minimum necessary time, preventing excessive product damage from prolonged low pH exposure

Inventive Principle:

Principle #35Parameter changes

4Reliability

If batch processing with holding tanks is used, then solution adjustments are thorough, but manual operations increase and automation is reduced

Engineering Contradiction:

Improvesolution adjustment accuracyVSAvoidmanual intervention requirement

Core Design Contradiction:

ReliabilityVSExtent of automation

Solution Approach 1:

The continuous flow system through modular incubation chambers eliminates batch processing steps and manual transfers. Solution adjustments are made inline continuously, reducing manual operations and enabling full automation while maintaining thorough mixing and adjustment through controlled flow dynamics

Inventive Principle:

Principle #20Continuity of useful action

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

The modular system provides flexible and efficient virus inactivation, reducing processing time and enabling continuous processing by maintaining narrow RTD, thus enhancing the purification of biomolecules while minimizing product damage.

Implementation Method 1

the coil flow inverter promotes secondary flow patterns that enhance mixing and reduce residence time distribution

Methodology Applied

Scientific EffectSecondary flow:

Implementation Method 2

introducing the liquid to be inactivated to a low pH solution (for example, under a pH of 3.6)... to inactive virus

Methodology Applied

Scientific EffectChemical denaturation:

Data Source

PatentUS20230064241A1Modular incubation chamber and method of virus inactivation

Publication Date: 2023.03.02 MERCK PATENT GMBH

AI summary

An incubation chamber that may be provided in modular form in order to provide flexibility in flow rate and/or residence time of a product stream is disclosed. Assemblies including such incubation chambers for purification of biomolecules are also disclosed, as are methods for biomolecule purification, and in particular, methods for virus inactivation in an incubation chamber or in a plurality of incubation chambers arranged in series.