HPV E7 Fusion Protein Vaccine Stability
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Solution Overview
Problem
Current vaccines for human papillomavirus (HPV) related diseases, particularly those targeting the E7 antigen, face challenges such as instability and protein aggregation during storage, which affects their efficacy and immunogenicity.
Innovation Solution
Development of fusion proteins combining a mutant HPV E7 antigen with an immunostimulatory polypeptide, such as calreticulin, which are designed to enhance solubility and stability, and are expressed in recombinant E. coli cells to improve storage stability and immunogenicity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current vaccines targeting E7 antigen are used, then they provide HPV disease prevention, but they suffer from instability and protein aggregation during storage
Solution Approach 1:
The patent combines the HPV E7 antigen with an immunostimulatory polypeptide (such as calreticulin) to create a fusion protein. This merging of two functional components resolves the contradiction by maintaining the antigenic properties of E7 while incorporating the stability-enhancing and aggregation-preventing characteristics of the immunostimulatory polypeptide, thereby improving vaccine reliability without compromising protein composition stability
Solution Approach 2:
The vaccine employs a composite protein structure consisting of the E7 antigen fused with an immunostimulatory polypeptide. This composite material approach allows the vaccine to benefit from both components: the E7 portion provides antigenicity while the immunostimulatory polypeptide portion provides enhanced stability and reduced aggregation倾向 during storage, thus resolving the technical contradiction between reliability and composition stability
2Stability of the object's composition
If fusion proteins with immunostimulatory polypeptide are developed, then solubility and stability are enhanced, but the device complexity increases
Solution Approach 1:
Rather than developing separate delivery systems or adjuvants to improve solubility and stability, the patent merges these functions directly into the antigen structure by fusing the immunostimulatory polypeptide with E7. This integration reduces overall system complexity while achieving the desired solubility and stability enhancements, effectively resolving the contradiction between improved composition stability and increased structural complexity
3Reliability
If fusion proteins are expressed in recombinant E. coli cells, then storage stability and immunogenicity are improved, but the manufacturing process becomes more complex
Solution Approach 1:
The patent utilizes parameter changes in the expression system by optimizing the fusion protein design for recombinant E. coli production. By modifying the protein sequence parameters (adding fusion tags, optimizing codon usage, adjusting structural parameters), the patent achieves improved storage stability and immunogenicity while maintaining compatibility with standard recombinant expression workflows, thus resolving the contradiction between enhanced reliability and manufacturing ease
Data Source
AI summary
The present invention provides a fusion protein comprising an immunostimulatory polypeptide and a mutant E7 protein of a human papilloma virus. The present invention also provides a gene encoding the fusion protein, expression vectors containing the gene, a pharmaceutical composition comprising the fusion protein, a method for treating or preventing a human papilloma virus related disease by using the fusion protein and uses of the fusion protein in the preparation of a medicament for the treatment or prevention of the human papilloma virus related disease.