Cellulose Sulfate Gel Purification of Inactivated SARS-CoV-2
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Solution Overview
Problem
Existing methods for producing inactivated SARS-CoV-2 vaccines struggle to achieve high purity by effectively removing host cell-derived impurities, particularly proteins, which can lead to safety concerns and reduced efficacy.
Innovation Solution
The use of cellulose sulfate ester gel chromatography under specific pH conditions (8 or more and 10 or less) for adsorbing and purifying SARS-CoV-2 or inactivated SARS-CoV-2, followed by impurity removal and elution, to obtain a highly purified vaccine with minimal host cell-derived proteins.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If ion exchange chromatography and/or size exclusion chromatography are used for purification, then the purification process is established, but the purity of the inactivated virus is insufficient due to presence of host cell-derived proteins
Solution Approach 1:
The invention changes the pH parameter to alkaline conditions (pH 8.0-10.0) during chromatography purification. This parameter change causes host cell-derived proteins to precipitate or adsorb onto the chromatography medium, while the inactivated virus remains in solution, thereby achieving separation and high purity recovery of the virus antigen
Solution Approach 2:
The invention creates different local conditions in the purification system: the alkaline pH environment selectively affects host cell proteins differently from the virus particles. This local quality difference allows selective removal of impurities while preserving the viral antigen integrity
2Manufacturing precision
If affinity chromatography is used for purification, then purification capability is enhanced, but the removal of host cell-derived proteins is still insufficient
Solution Approach 1:
The invention combines affinity chromatography with alkaline pH conditions (pH 8.0-10.0). This parameter change causes host cell-derived proteins to precipitate or adsorb non-specifically onto the affinity medium, while the virus-antibody complex remains bound specifically, enabling separation and high purity recovery
3Reliability
If conventional purification methods are used, then the production process is established, but the vaccine contains impurities that reduce safety
Solution Approach 1:
The invention uses alkaline pH conditions (pH 8.0-10.0) during chromatography to cause host cell-derived proteins to precipitate or adsorb, while the inactivated virus remains in solution. This parameter change achieves effective separation, producing high purity vaccine with minimal impurities and enhanced safety
Solution Approach 2:
The invention extracts and removes host cell-derived protein impurities from the virus antigen solution through alkaline-induced precipitation or adsorption during chromatography, separating the harmful impurities from the beneficial viral antigen to produce a safer vaccine
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 results in a high-purity inactivated SARS-CoV-2 vaccine with substantially no host cell-derived proteins, enhancing safety and immunogenicity, and allows for the production of a SARS-CoV-2 antigen composition with similar purity.
Implementation Method 1
bringing a SARS-CoV-2 comprising solution or an inactivated SARS-CoV-2 comprising solution into contact with a cellulose sulfate ester gel at a pH of 8 or more and 10 or less to adsorb the SARS-CoV-2 or the inactivated SARS-CoV-2 to the gel
Data Source
AI summary
The present invention relates to a production method of an inactivated SARS-CoV-2 vaccine, the method including: a step of bringing a SARS-CoV-2 containing solution or an inactivated SARS-CoV-2 containing solution into contact with a cellulose sulfate ester gel at a pH of 8 or more and 10 or less to adsorb the SARS-CoV-2 or the inactivated SARS-CoV-2 to the gel; then removing impurities; and then eluting and recovering the SARS-CoV-2 or the inactivated SARS-CoV-2.