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AssigneeModernaTX, Inc.
InventorsPhilip White, Jack F. Kramarczyk, Julia O'Neill, Nedim Emil Altaras
Estimating the term…
Present application relates to a strategy for compensating for transesterification degradation of lipid-encapsulated RNA, such as mRNA-LNP, in liquid formulations for high-volume distribution. This involves determining the rate of degradation of the encapsulated RNA and calculating an appropriate overage relative to the intended dose. Alternatively, a higher dose of the RNA may be administered to compensate for loss of effective RNA or the RNA may be formulated in higher purity in anticipation of degradation. The strategy provides a balance between supplying effective and safe products and the need for costly manufacturing processes or transportation hurdles, such as cold-chain supply.
An article, comprising:
An article, comprising:
The article of any of the preceding claims, wherein the article comprises a vial, a syringe, a cartridge, an infusion pump, and/or a light protective container.
The article of any preceding claims, wherein the amount is greater than or equal to 1.05×(an individual dose of the liquid pharmaceutical composition), such as greater than or equal to 1.2×(an individual dose of the liquid pharmaceutical composition).
The article of any preceding claim, wherein the RNA is encapsulated within the lipid nanoparticle, liposome, or lipoplex.
The article of any preceding claim, wherein the lipid nanoparticle, liposome, or lipoplex comprises a lipid nanoparticle.
An article, comprising:
An article, comprising:
The article of any preceding claim, wherein the RNA comprises mRNA.
The article of any preceding claim, wherein the RNA comprises greater than or equal to 400, 500, 1000, 2000, 3000, 4000, 5000, 6000, 7000, or 8000 nucleotides.
The article of any preceding claim, wherein the RNA comprises less than or equal to 15,000, 14,000, 13,000, 12,000, 11,000, 10,000, 9000, 8000, 7000, or 6000 nucleotides.
The article of any preceding claim, wherein the liquid pharmaceutical composition is formulated in an aqueous solution.
A pharmaceutical composition comprising mRNA encapsulated in a lipid nanoparticle, wherein the composition comprises a total amount of intact mRNA that is greater than an effective amount of intact mRNA, and wherein the composition comprises at least the effective amount of the intact mRNA after storage of the composition for a period of time.
A method of filling an article, comprising:
A method of delivering an effective dose of an RNA to a subject, comprising;
A method of compensating for transesterification of mRNA in a composition comprising the mRNA encapsulated by a lipid nanoparticle, the method comprising preparing the composition with increased mRNA purity as compared to an mRNA purity that will be present in the composition after storage of the composition, such that the amount of mRNA present in the composition after storage will comprise an effective amount of the mRNA.
Dependencies are inferred from the claim text.