	US 11,786,607 B2
	RNA formulations
Stephen Hoge, Brookline, MA (US); Joseph Schariter, Waltham, MA (US); Charles Bowerman, Waltham, MA (US); Michael H. Smith, Needham, MA (US); and Yan Xia, Natick, MA (US)
Assigned to ModernaTX, Inc., Cambridge, MA (US)
Appl. No. 16/623,069
Filed by ModernaTX, Inc., Cambridge, MA (US)
PCT Filed Jun. 15, 2018, PCT No. PCT/US2018/037922 § 371(c)(1), (2) Date Dec. 16, 2019, PCT Pub. No. WO2018/232357, PCT Pub. Date Dec. 20, 2018.
Claims priority of provisional application 62/590,200, filed on Nov. 22, 2017.
Claims priority of provisional application 62/520,530, filed on Jun. 15, 2017.
Prior Publication US 2021/0145982 A1, May 20, 2021
Int. Cl. A61K 47/69 (2017.01); A61K 47/54 (2017.01); A61K 31/7105 (2006.01)

CPC A61K 47/6931 (2017.08) [A61K 31/7105 (2013.01); A61K 47/543 (2017.08)]

22 Claims

1. A composition comprising an enriched population of lipid nanoparticles (LNPs), wherein the LNPs have an outer shell and an inner core and comprise an ionizable lipid, a phospholipid, a poly(ethylene glycol) (PEG) lipid, wherein at least 50% of the LNPs comprise mRNA encapsulated within the inner core and wherein the outer shell comprises at least 95% of the total PEG lipid in the LNP, and wherein the LNP's are formed by a nanoprecipitation process including a step in which additional PEG lipid was added to the LNP's after an initial nanoprecipitation reaction.