A microneedle-based system uses cryogenically pre-cooled needles coated via thin-film freeze-coating to preserve mRNA stability, enabling efficient, multi-therapeutic intradermal delivery of temperature-sensitive drugs.
Background
The field of advanced drug delivery systems has grown substantially as the biomedical industry grapples with the complexities of transporting labile therapeutic molecules, particularly mRNA and other temperature-sensitive biologics. There is an increasing urgency to develop methods that ensure the stability and efficacy of these agents during storage and administration. The inherent instability of mRNA, its vulnerability to degradation, and its requirement for stringent cold-chain logistics highlight the need for innovative delivery solutions. These demands drive a continuous search for approaches that can maintain molecular integrity while potentially reducing patient discomfort and simplifying self-administration processes.
Current approaches face significant challenges that hinder reliable and scalable therapeutic deployment. Traditional methods often struggle with preserving the structural integrity of sensitive molecules under variable environmental conditions, leading to suboptimal stability and reduced immunogenicity. Limitations in controlling drug loading, ensuring precise deposition, and managing release kinetics compromise both treatment effectiveness and safety. Additionally, conventional techniques frequently involve cumbersome logistics and high production costs, thereby restricting rapid and widespread clinical use. Such issues necessitate rethinking current frameworks to overcome the barriers associated with conducting efficient, cost-effective, and patient-friendly therapy delivery.
Technology description
The technology employs microneedle arrays made from materials like stainless steel or polymers that are cryogenically pre-cooled before undergoing a thin-film freeze-coating process with an mRNA-lipid nanoparticle suspension. This method features multi-layered application, differential loading on individual needles, and co-delivery of multiple therapeutics. The process incorporates precise control over coating parameters, rapid freezing, and lyophilization to preserve the structural integrity of temperature-sensitive agents. It also utilizes a formulation enriched with buffer agents, sugars, surfactants, amino acids, and viscosity enhancers to optimize delivery efficiency.
The platform differentiates itself by addressing the challenges inherent in delivering temperature-sensitive therapeutics through enhanced stability and improved intradermal administration. Its innovative pre-cooling and coating techniques yield superior mRNA preservation compared to conventional air-drying methods, while the ability to customize individual needle coatings and adjust solution properties ensures optimal drug loading. These attributes, combined with compatibility with aseptic manufacturing protocols and potential for self-administration, mark a significant advancement in achieving dose-sparing effects and enhanced immunogenicity.
Benefits
- Enhanced mRNA stability through cryogenic pre-cooling and rapid freeze-lyophilization
- Improved intradermal delivery with potential dose-sparing and increased immunogenicity
- Capability for multi-layered and differential microneedle coatings enabling co-delivery of multiple therapeutics
- Versatility to deliver various temperature-sensitive biologics beyond mRNA vaccines
- Enhanced manufacturing efficiency with precise coating control and compatibility with aseptic processes
Commercial applications
- mRNA vaccine microneedle patch
- Intradermal biologics delivery system
- Self-administer drug delivery platform
- Multi-therapeutic combination patch
Additional information
A specialized process uses cryogenically pre-cooled microneedle arrays made from materials like stainless steel or polymers. An mRNA–lipid nanoparticle suspension, containing buffers, sugars, surfactants, and viscosity enhancers, is applied and rapidly frozen via a thin-film freeze-coating and drying method. This preserves mRNA integrity while enabling multi-layered, differential loading for co-delivery of diverse therapeutics under aseptic conditions.
Intellectual property
U.S. Provisional application serial no. 63/881,045 filed
