Subcritical Carbon Dioxide Virus Inactivation
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Solution Overview
Problem
Current virus inactivation methods in biopharmaceutical manufacturing are costly and may damage sensitive products, and there is a need for an economical method that provides an orthogonal mode of action to enhance virus inactivation strategies without harming biopharmaceutical or other sensitive products.
Innovation Solution
Exposing biological or sensitive substances to carbon dioxide at temperatures and pressures below its critical state, either by dissolving it into the substance or exposing it as a gas, for a prescribed treatment time, which can be combined with acid treatments to achieve virus inactivation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current virus inactivation methods (low pH, chemical treatments, high temperature) are used, then viruses are effectively inactivated, but the biopharmaceutical product may be damaged or degraded
Solution Approach 1:
The patent changes the physical-chemical parameters of carbon dioxide from supercritical state (high pressure and temperature) to subcritical dissolved state (lower pressure and temperature). This parameter change allows virus inactivation to occur at conditions that are less harsh on the biopharmaceutical product, thereby reducing product damage while maintaining inactivation efficacy
Solution Approach 2:
Carbon dioxide acts as an intermediary substance that transfers the inactivation effect to viruses without directly contacting or damaging the product. The dissolved CO2 creates a controlled environment that selectively affects viruses while leaving the biopharmaceutical product intact
2Reliability
If multiple inactivation techniques and additional purification steps are added, then virus safety is improved, but manufacturing cost and process complexity increase
Solution Approach 1:
The dissolved carbon dioxide treatment serves multiple functions simultaneously: it inactivates viruses, maintains product stability, and can be integrated into existing process steps. This multi-functionality reduces the need for separate dedicated virus inactivation steps and additional purification operations
Solution Approach 2:
The patent combines the virus inactivation function with existing manufacturing process steps by dissolving CO2 into the product solution during normal processing. This merging approach eliminates the need for separate inactivation vessels and additional purification steps, thereby reducing overall process complexity
3Reliability
If supercritical carbon dioxide is used for virus inactivation, then inactivation efficacy is improved, but equipment cost and operational complexity increase due to high pressure requirements
Solution Approach 1:
The patent deliberately changes the pressure and temperature parameters from supercritical conditions to subcritical conditions. This parameter change allows the use of standard pharmaceutical equipment rather than specialized high-pressure supercritical fluid equipment, significantly reducing equipment cost and operational complexity while maintaining adequate inactivation efficacy
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 method effectively inactivates viruses with minimal damage to the products, offering a cost-effective and robust virus inactivation strategy that is compatible with existing manufacturing processes, reducing the need for additional purification steps and maintaining product quality.
Implementation Method 1
dissolving carbon dioxide into a composition containing the biological or other sensitive substance
Implementation Method 2
exposing it as a gas, for a prescribed treatment time
Data Source
AI summary
Methods and systems for virus inactivation in the production or processing of biological or other sensitive substances are provided. The disclosed methods and systems for virus inactivation involve the key steps of dissolving carbon dioxide into biological or other sensitive substances; and treating the substance with the dissolved carbon dioxide at conditions which are less than critical pressure and temperature for a prescribed treatment time to inactivate at least 80% of the target virus or viruses contained within the biological or other sensitive substances. The disclosed carbon dioxide treatments for virus inactivation may optionally include concurrently or sequentially subjecting the substances with an acid treatment to lower the pH of the substance and inactivate viruses contained within the biological or other sensitive substance. Operating conditions for the disclosed carbon dioxide treatments preferably involve sparging carbon dioxide gas into the substance until the composition is saturated with carbon dioxide and is conducted at pressures below about 5 MPa; at temperatures of less than or equal to 30° C.; and for a treatment time of between about one minute and about 2000 minutes.