Enterovirus Purification and Inactivation Process
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Solution Overview
Problem
The challenge lies in scaling up the production of Inactivated Polio Vaccine (IPV) at an industrial level while reducing costs, as current methods are inefficient and costly, impacting global vaccine supply and accessibility.
Innovation Solution
A novel process involving the production of Enteroviral (D-Antigen) particles in Vero cells, followed by purification through Single Step or Two Step Chromatography, stabilization, and inactivation using formaldehyde or other methods, with the addition of excipients and adjuvants, achieving high antigen recovery rates of 80% to 99%.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If current industrial scale production methods are used for IPV, then vaccine supply can be maintained, but production costs are high and efficiency is low
Solution Approach 1:
The patent modifies critical process parameters including pH (maintained at 7.0-7.2), temperature (37°C), and formaldehyde concentration (0.025-0.05%) to optimize both production efficiency and cost-effectiveness. The buffered formaldehyde inactivation system allows for precise parameter control that improves yield while reducing waste and rework costs
Solution Approach 2:
The patent introduces phosphate-buffered saline (PBS) and sodium acetate as intermediary buffering agents that mediate the inactivation process. These intermediaries stabilize pH during formaldehyde treatment, preventing antigen degradation and improving overall process efficiency while reducing the need for expensive corrective measures
2Reliability
If antigen recovery is maximized through extensive purification, then vaccine efficacy is improved, but production time and cost increase
Solution Approach 1:
The patent performs preliminary buffer exchange and pH adjustment before the inactivation step, ensuring optimal conditions are established in advance. This preliminary preparation prevents antigen degradation during processing and eliminates the need for extensive post-purification steps, achieving high efficacy while reducing overall production time
Solution Approach 2:
The buffered formaldehyde inactivation system maintains continuous optimal pH conditions throughout the entire inactivation period (7-14 days), ensuring sustained antigen stability and efficacy without requiring intermittent adjustments or additional purification cycles that would extend production time
3Reliability
If formaldehyde inactivation is performed without buffering, then process simplicity is maintained, but antigen stability and recovery are reduced
Solution Approach 1:
The patent changes the chemical environment by introducing phosphate buffer and sodium acetate systems that maintain pH at optimal levels (7.0-7.2) throughout inactivation. This parameter modification ensures antigen stability and high recovery rates while adding only a simple buffering step to the process
Solution Approach 2:
The patent uses inexpensive, readily available buffering agents (phosphate-buffered saline and sodium acetate) that can be easily prepared and discarded after use. These cheap intermediaries provide substantial stability benefits without requiring complex equipment or sophisticated process controls
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 process enables cost-effective, large-scale production of stable and effective IPV vaccines, enhancing accessibility and affordability, and ensuring high antigen recovery and vaccine stability.
Implementation Method 1
production of Enteroviral (D-Antigen) particles in Vero cells
Implementation Method 2
purification through Single Step or Two Step Chromatography
Implementation Method 3
inactivation using formaldehyde or other methods
Data Source
AI summary
The present invention pertains to the field of industrial scale inactivation of various enteroviruses and large and industrial scale production of enterovirus vaccine compositions and combinations of various enteroviruses so obtained.