BioNTech has filed a patent for a method to prepare pharmaceutical compositions using lipid nanoparticles and mRNA without certain additives. The frozen form of the composition is intended for therapy. GlobalData’s report on BioNTech gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on BioNTech, Personalized cancer vaccines was a key innovation area identified from patents. BioNTech's grant share as of January 2024 was 35%. Grant share is based on the ratio of number of grants to total number of patents.
Pharmaceutical composition preparation method using lnps and mrna
A patent application (Publication Number: US20240033344A1) describes a method for preparing a pharmaceutical composition using lipid nanoparticles (LNPs) containing a cationically ionizable lipid and mRNA. The method involves preparing a formulation without adding NaCl and/or KCl, ensuring the pH is lower than the pKa of the lipid, and being free of citric and inorganic phosphate anions. The formulation is then frozen to about -10°C or below to obtain the pharmaceutical composition in frozen form. Additional steps include freeze-drying the frozen formulation and incorporating a buffer system and/or a cryoprotectant. The LNPs may also contain additional lipids such as polymer conjugated lipids, neutral lipids, and steroids. The pharmaceutical composition can be stored at temperatures ranging from -30°C to -10°C for extended periods.
Furthermore, the pharmaceutical composition can be used for therapy or to induce an immune response. The LNPs in the composition have a size ranging from 50 nm to 500 nm after thawing or reconstitution. The method ensures the size and distribution of LNPs remain consistent before and after freezing or freeze-drying. The composition may also contain a chelating agent, a buffer system comprising HEPES, histidine, Tris, or acetic acid, and a cryoprotectant like sucrose or trehalose. The mRNA in the composition can encode polypeptides with epitopes for immune response, including SARS-CoV-2 S protein variants. The patent application covers various formulations and methods for preparing, storing, and using the pharmaceutical composition, emphasizing the importance of specific conditions and components to maintain stability and efficacy.
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