Invention Title:

mRNA VACCINE COMPOSITION WITH IMPROVED STORAGE STABILITY

Publication number:

US20250144037

Publication date:
Section:

Human necessities

Class:

A61K9/5123

Inventors:

Assignees:

Applicants:

Drawings (4 of 5)

Smart overview of the Invention

An innovative mRNA vaccine composition is designed to enhance storage stability, addressing the logistical challenges associated with current mRNA vaccine storage requirements. This advancement focuses on maintaining vaccine efficacy while reducing the need for ultra-cold storage conditions, making it more accessible for regions with limited resources.

Background

The rapid development of mRNA vaccines during the COVID-19 pandemic highlighted their adaptability and production speed, yet their requirement for extremely low storage temperatures remains a significant hurdle. Traditional vaccines can be stored at 2° C. to 8° C., while mRNA vaccines require much colder environments, complicating distribution, especially in areas lacking specialized infrastructure.

Innovative Approach

The invention introduces a method combining low-temperature decompression concentration with stabilizers to preserve mRNA vaccine efficacy at standard refrigeration temperatures. This approach leverages lipid nanoparticle (LNP) technology and incorporates cryoprotectants like glycerol to stabilize the mRNA structure, ensuring over 90% efficacy retention while minimizing cold chain demands.

Technical Details

The vaccine composition comprises mRNA encapsulated within LNPs and stabilized by glycerol. The LNPs are composed of various lipids, including ionizable lipids and phospholipids. Glycerol, recognized as safe by the FDA, is used in concentrations of 10% to 30% (w/v) to maintain structural integrity and prevent degradation of the mRNA during storage.

Applications and Benefits

This development not only improves the logistical feasibility of distributing mRNA vaccines but also enhances their potential for broader therapeutic applications. By maintaining efficacy under less stringent storage conditions, the invention supports more widespread vaccination efforts against infectious diseases and cancer, offering a versatile and cost-effective solution in the pharmaceutical landscape.