Continuous Diafiltration for Immunogenic Composition Production
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for producing immunogenic compositions with reduced virucidal activity face limitations in scaling up, particularly in achieving significant concentration of recombinant proteins while maintaining low virucidal effects, as existing techniques may increase production volume unnecessarily and fail to adequately reduce virucidal activity to meet regulatory standards.
Innovation Solution
A method involving continuous diafiltration of a mixture containing recombinant protein and quaternary structures, where the solution is processed against a second liquid different from the first, allowing for concentration and reduction of inactivating and neutralizing agents, thereby reducing virucidal activity and achieving scalable production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional concentration methods are used to increase recombinant protein concentration, then productivity improves, but virucidal activity increases beyond regulatory limits
Solution Approach 1:
The patent applies parameter changes by modifying the chemical composition parameters of the composition through continuous diafiltration. Specifically, the process adjusts the concentration of inactivating and neutralizing agents while maintaining recombinant protein concentration, thereby changing the overall chemical parameters to achieve reduced virucidal activity that meets regulatory standards while preserving productivity
Solution Approach 2:
The patent applies extraction by removing excess inactivating and neutralizing agents from the composition through continuous diafiltration. This separation process extracts the harmful components (excess agents causing virucidal activity) while retaining the beneficial recombinant protein, thereby reducing virucidal activity to acceptable levels without sacrificing protein concentration
2Productivity
If batch processing is used for production, then device complexity is reduced, but productivity and scalability are limited
Solution Approach 1:
The patent applies continuity of useful action by implementing continuous diafiltration processing instead of batch processing. This continuous operation allows for uninterrupted removal of inactivating and neutralizing agents while maintaining protein concentration, significantly improving productivity and scalability. The continuous flow system enables larger production volumes without proportionally increasing device complexity
Solution Approach 2:
The patent applies dynamics by using a dynamic continuous processing system where flow rates, concentrations, and processing parameters can be adjusted in real-time. This dynamic approach allows optimization of the diafiltration process for different production scales, enabling flexible scaling from small to large production volumes while managing system complexity through controllable variable parameters
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 reduces virucidal activity while concentrating recombinant proteins, enabling the production of immunogenic compositions on a larger scale with minimal loss of live virus, meeting regulatory standards and ensuring stability and effectiveness.
Implementation Method 1
processing the solution resulting from step (b) by continuous diafiltration
Implementation Method 2
removing a portion of the first liquid from the mixture
Implementation Method 3
processing the solution resulting from step (b) by continuous diafiltration, in particular by continuous diafiltration against a second liquid
Data Source
AI summary
The present invention in particular relates to a method of producing an immunogenic composition exhibiting reduced virucidal activity, as well as to the immunogenic composition and uses thereof, wherein the method in particular comprises the steps of: (a) providing a mixture with a first liquid and a recombinant protein, (b) concentrating the recombinant protein in the mixture by removing a portion of the first liquid from the mixture, and (c) processing the solution resulting from step (b) by continuous diafiltration.