Hyperimmune IgG and IgM Compositions for COVID-19 Treatment
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Solution Overview
Problem
Current treatments for COVID-19 lack effective therapeutic options, and convalescent plasma therapy faces challenges such as variability in antibody titer and neutralizing power, transfusion-associated risks, and lack of validated pathogen reduction processes.
Innovation Solution
Development of highly pure liquid therapeutic hyperimmune globulin compositions comprising IgG and/or IgM antibodies derived from SARS-CoV-2 convalescent plasma, with enhanced antibody titer and neutralization activity, and a method for virus clearance and blood typing to reduce transfusion risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If convalescent plasma is used for treatment, then passive immunity is provided, but variability in antibody titer and neutralizing power occurs
Solution Approach 1:
The patent extracts and purifies specific immunoglobulins (IgG and/or IgM) with anti-SARS-CoV-2 activity from convalescent plasma, separating the beneficial antibodies from the variable plasma background. This extraction process isolates the active components, providing consistent antibody titers while maintaining therapeutic effectiveness.
Solution Approach 2:
The patent applies purification and concentration processes that change the parameters of the plasma, specifically increasing antibody concentration and purity while reducing variability. Through controlled purification steps, the composition achieves standardized antibody titers and neutralizing activity, resolving the inconsistency issue.
2Reliability
If convalescent plasma is infused, then passive immunity is provided, but transfusion-associated risks occur
Solution Approach 1:
The patent extracts only the necessary immunoglobulin components from convalescent plasma, removing harmful elements such as blood cells, potential pathogens, and other plasma proteins that could cause transfusion reactions. This selective extraction maintains therapeutic benefits while eliminating risks.
Solution Approach 2:
The patent processes convalescent plasma through purification steps that convert the potentially harmful raw plasma into a safe, standardized therapeutic product. The purification process eliminates pathogens and harmful components while preserving and concentrating the beneficial antibodies, effectively converting a risky treatment into a safe one.
3Adaptability or versatility
If convalescent plasma is used, then treatment option is provided, but lack of validated pathogen reduction processes occurs
Solution Approach 1:
The patent extracts immunoglobulins from convalescent plasma through purification processes that simultaneously remove potential pathogens. The extraction and purification steps isolate the therapeutic antibodies while eliminating viral and bacterial contaminants, providing both treatment availability and pathogen safety.
Solution Approach 2:
The patent applies purification technologies that convert the risky convalescent plasma into a safe therapeutic product. Through validated purification processes, potential pathogens are eliminated while the beneficial antibodies are preserved and concentrated, making the treatment both available and safe.
4Quantity of substance
If plasma volume is increased for treatment, then antibody delivery is improved, but transfusion-associated circulatory overload occurs
Solution Approach 1:
The patent concentrates antibodies into a smaller volume through purification and formulation processes, changing the concentration parameter. This allows delivery of the required antibody quantity in a reduced volume, avoiding circulatory overload while maintaining effective treatment doses.
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 hyperimmune globulin compositions demonstrate improved antibody titer and neutralization activity, reducing COVID-19 symptoms, morbidity, and mortality, while minimizing transfusion-related risks through validated pathogen clearance and blood typing processes.
Implementation Method 1
having a SARS-CoV-2 neutralization activity between 1.5 and 15 per mg/mL of IgG
Data Source
AI summary
Hyperimmune IgG and/or IgM compositions and method for preparing thereof and method for obtaining hyperimmune human plasma from a donor. A liquid therapeutic hyperimmune globulin composition including human plasma-derived immunoglobulin G (IgG) having antibody titre between 250 and 2,500 per mg/mL of IgG and/or a SARS-CoV-2 neutralization activity (IC50 neutralization titer) between 1.5 and 15 per mg/mL of IgG for use in the treatment of coronavirus disease 2019 (COVID-19) in a patient in need thereof. A liquid therapeutic or prophylactic hyperimmune immunoglobulin composition including human plasma-derived immunoglobulin M (IgM) having a SARS-CoV-2 titre between 2,000 and 17,000 and/or a SARS-CoV-2 neutralization activity (IC50 neutralization titre) between 200 and 70,000, methods for preparing thereof, and the use thereof for the treatment or prophylaxis of COVID-19. A method for obtaining hyperimmune human plasma from a donor for use in the treatment of COVID-19.