Split-Dose mRNA Vaccine Delivery for Sustained Immune Response
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Solution Overview
Problem
Current mRNA vaccines face challenges in global supply chain logistics, high production costs, and the need for frequent dosing, limiting their widespread availability and affordability.
Innovation Solution
A method involving split-dose administration of an active pharmaceutical ingredient (API), such as mRNA, where each dose is less than the effective amount in a bolus dose, with optional repeat administrations over time, utilizing a lipid nanoparticle (LNP) formulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If conventional bolus dosing is used for mRNA vaccines, then the vaccine provides effective immune response, but the high production costs and frequent dosing requirements limit accessibility
Solution Approach 1:
The patent applies segmentation by dividing the total mRNA dose into multiple smaller split-doses administered at different time points. This approach reduces the overall mRNA quantity required while maintaining immune response efficacy through sustained antigen expression and repeated stimulation of the immune system.
Solution Approach 2:
The patent implements periodic action by scheduling multiple doses at specific time intervals. This periodic administration pattern allows for sustained immune activation and memory formation while reducing the total mRNA load required compared to a single bolus dose.
2Ease of manufacture
If multiple split-doses are administered over time, then the overall mRNA dose is reduced and cost-effectiveness is improved, but the administration process becomes more complex
Solution Approach 1:
By segmenting the dosing regimen into standardized split-dose units, the patent simplifies manufacturing and supply chain logistics while reducing total material costs. The segmented approach allows for more efficient production scaling and reduced waste.
3Ease of operation
If mRNA vaccines are administered as single bolus doses, then the delivery process is simple, but the frequent dosing requirement increases logistics complexity
Solution Approach 1:
The patent uses periodic action to establish a structured dosing schedule that reduces the frequency of administrations. By spacing doses at optimal intervals, the system maintains immune efficacy while reducing the time loss associated with frequent dosing requirements.
Data Source
AI summary
The invention relates to a method of treating a disease or disorder in a patient in need thereof that includes providing an active pharmaceutical ingredient (API) to the patient by administering more than one split-dose of the API over a pre-determined period of time. In embodiments of the invention, the API is an mRNA encoding an antigen. The attractiveness of mRNA as a vaccine modality is supported by several advantages. As a non-infectious agent that does not require incorporation into the host's genome to confer activity along with its well-defined chemical composition, mRNA is regarded as a relatively safe vaccine modality.