Surfactant Virus Inactivation in Factor VII Compositions

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Solution Overview

Problem

Current methods for producing blood coagulation factor VII (FacVII) face challenges in inactivating viruses without reducing the factor's titer, which is crucial for treating hemophilia A and B, as viral contamination risks are high during recombinant production using animal cells.

Innovation Solution

Adding a surfactant, such as Tween or Triton X-100, to a composition containing FacVII or its derivative at specific concentrations and pH levels to effectively inactivate viruses while maintaining the factor's activity and titer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If virus inactivation process is applied to FacVII composition, then viral safety is improved, but FacVII titer decreases

Engineering Contradiction:

Improveviral safetyVSAvoidFacVII titer

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The patent applies parameter changes by optimizing the pH range (5.0-8.0) and surfactant concentration (0.01-1.00% w/v) to achieve effective virus inactivation while minimizing FacVII degradation. By carefully controlling these parameters, the process maintains higher FacVII titer compared to conventional inactivation methods.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces a surfactant as an intermediary substance that mediates between the virus inactivation requirement and FacVII preservation. The surfactant enables effective virus inactivation through mechanisms like membrane disruption while creating a protective environment that reduces FacVII degradation, thus resolving the contradiction between viral safety and titer maintenance.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If recombinant production using animal cells is used, then FacVII production efficiency is improved, but viral contamination risk increases

Engineering Contradiction:

ImproveFacVII production efficiencyVSAvoidviral contamination risk

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent converts the harmful effect of viral contamination into a benefit by using the same animal cell production system that causes viral risk, then applying surfactant treatment that specifically targets and inactivates viruses while leaving FacVII intact. This approach maintains the productivity advantages of animal cell culture while eliminating the viral contamination hazard.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If conventional virus inactivation methods are applied, then viral safety is improved, but FacVII activity decreases

Engineering Contradiction:

Improveviral safetyVSAvoidFacVII activity

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

The patent achieves both viral safety and FacVII activity preservation by changing the physical-chemical parameters of the inactivation process. By operating at pH 5.0-8.0 and using surfactant concentrations of 0.01-1.00% w/v, the method creates conditions that are lethal to viruses but compatible with maintaining FacVII structural integrity and biological activity.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The surfactant serves as an intermediary that enables virus inactivation through alternative mechanisms (such as disrupting viral envelopes) that do not rely on conditions harmful to FacVII. This mediator substance allows decoupling of virus killing from protein degradation, preserving FacVII activity while achieving viral safety.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 method allows for the effective inactivation of viruses in FacVII compositions without reducing the protein's activity or titer, making it suitable for producing prophylactic and therapeutic agents for hemophilia without the risk of viral contamination.

Implementation Method 1

adding a surfactant to a composition comprising blood coagulation factor VII or a derivative thereof

Methodology Applied

Scientific EffectSurfactant: Surfactant

Data Source

PatentEP2950810B1A method of virus inactivation in composition comprising factor vii

Publication Date: 2019.07.17 HANMI PHARM CO LTD

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AI summary

The present invention relates to a method for inactivating viruses in a composition comprising blood coagulation factor VII, and more particularly, to a method for inactivating viruses comprising adding a surfactant to a composition comprising blood coagulation factor VII or a derivative thereof and a method for preparing a virus-inactivated composition comprising blood coagulation factor VII or the derivative thereof.