A thin film freezing method transforms mRNA and lipid nanoparticles into stable dry powders that retain their effectiveness and size. This eliminates the need for ultra-cold storage, allowing the powders to be inhaled or reconstituted, improving the distribution of mRNA therapies.
mRNA therapeutics represent a groundbreaking advancement in medicine, offering the potential to treat a wide range of diseases by instructing cells to produce specific proteins. This technology has gained significant attention, especially highlighted by its successful application in COVID-19 vaccines. The ability to rapidly develop and deploy mRNA-based treatments holds promise for addressing various genetic disorders, cancers, and infectious diseases. However, the effective distribution and storage of these therapeutics are critical to their widespread adoption and success, necessitating innovative solutions to overcome existing logistical challenges.
Currently, mRNA/lipid nanoparticle (LNP) complexes require ultra-low temperature storage to maintain their stability and efficacy, as seen with many COVID-19 vaccines. This dependency on strict cold chain logistics presents significant barriers, including increased costs, limited accessibility in regions without advanced refrigeration infrastructure, and potential degradation during transportation. Traditional shelf-freeze drying methods often fail to preserve the encapsulation efficiency and size of nanoparticles, leading to drug leakage and particle growth, which can compromise the therapeutic effectiveness. These limitations hinder the scalability and global distribution of mRNA-based treatments, underscoring the urgent need for more stable and versatile formulation approaches.
This technology utilizes thin film freezing to transform mRNA and lipid nanoparticle complexes into stable, dry powder formulations. The process maintains encapsulation efficiency and preserves nanoparticle size while minimizing drug leakage during production. By employing rapid freezing and advanced drying techniques, the method achieves a lower bulk density without significant particle growth. This results in powders that do not require ultra-low temperature storage, making them suitable for inhalation or easy reconstitution. The formulations effectively address the storage and distribution challenges associated with mRNA therapeutics, as demonstrated with COVID-19 vaccines, and are applicable to a wide range of nucleic acid-based treatments.
What sets this technology apart is its ability to preserve the critical characteristics of mRNA/LNP complexes without relying on traditional shelf-freeze drying methods. The thin film freezing (TFF) process ensures high encapsulation efficiency, maintains the original size of lipid nanoparticles, achieves lower bulk density, prevents particle growth, and minimizes drug leakage. These advantages eliminate the need for cold chain logistics, significantly reducing storage and distribution costs while maintaining therapeutic efficacy.
Developed using commercially available materials and validated with COVID-19 vaccines, this approach offers a scalable and versatile solution for various nucleic acid formulations. Its potential to transform pharmaceutical formulation and delivery systems has attracted commercial interest, highlighting its unique position in the rapidly expanding field of mRNA-based therapeutics.
mRNA vaccine storage solutions
The University of Texas at Austin is seeking an industry partner to license the patent and commercialize this technology.