Human Antibody Production via Pre-Immunization
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Solution Overview
Problem
Current vaccine therapeutic strategies focus on antigens rather than cytokine regulation, leading to inefficiencies in addressing cytokine-related immunosuppression and inflammation, particularly in cancer and AIDS, where natural anti-cytokine antibodies with low affinity and low titers are insufficient to neutralize cytokine activity effectively.
Innovation Solution
Development of a high-yield method to produce human antibodies that neutralize the biological activity of cytokines like VEGF, IFNα, IL-4, TNFα, and TGFβ, involving immunization with stable immunogenic products comprising protein immunogene heterocomplexes and subsequent purification of polyclonal or monoclonal antibodies, Fab or F(ab)′2 fragments, and ScFv fragments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If natural anti-cytokine antibodies are used, then the treatment is simple and safe, but the antibody affinity and titer are low, resulting in insufficient neutralization of cytokine activity
Solution Approach 1:
The patent applies preliminary action by pre-immunizing individuals with cytokines before collecting antibodies. This preliminary immunization step ensures that when blood is collected, the individuals already have high-titer, high-affinity anti-cytokine antibodies in their serum, eliminating the need for complex in vitro antibody production methods while ensuring sufficient neutralization efficacy
Solution Approach 2:
The patent utilizes the human immune system's natural antibody production capability. By immunizing individuals and then collecting their serum, the body itself produces the required high-affinity antibodies, which are then purified through relatively simple steps. This self-service approach avoids complex recombinant DNA technology while achieving high neutralization efficacy
2Manufacturing precision
If complex purification steps are implemented, then antibody purity and yield are improved, but the manufacturing process becomes more complex and time-consuming
Solution Approach 1:
The patent applies the extraction principle by directly obtaining high-affinity anti-cytokine antibodies from the serum of pre-immunized individuals. The purification process extracts the desired antibodies from serum through relatively simple steps, avoiding complex multi-stage purification protocols while maintaining high antibody purity and yield, thus preserving production efficiency
Solution Approach 2:
The patent changes the source parameter from recombinant production to natural serum antibodies. By utilizing antibodies naturally produced in human serum after immunization, the method achieves high purity with simpler purification steps, as the antibodies are already present in high concentration and affinity, reducing the need for extensive purification
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
The method achieves high-affinity antibodies that effectively inhibit at least 50% of the maximal biological activity of target cytokines in vitro, providing a direct and efficient treatment for cytokine-mediated immunosuppression and inflammation without the need for complex purification steps.
Implementation Method 1
human antibodies that neutralize the biological activity of a human cytokine
Data Source
AI summary
The invention concerns a pharmaceutical composition comprising, as the active ingredient, human natural antibodies of the IgG isotype, that neutralize the activity of a human cytokine selected from VEGF, IFNα, IL-4, TNFα and TGFβ, the said neutralizing antibodies inhibiting at least 50% of the maximum biological activity induced by an amount ranging from 0.006 ng to 0.05 ng of the said cytokine in vitro.