	US 12,251,474 B2
	Process for lyophilized pharmaceutical formulations of a therapeutic protein
Clea Talley, Camarillo, CA (US)
Assigned to AMGEN INC., Thousand Oaks, CA (US)
Appl. No. 16/652,667
Filed by AMGEN INC., Thousand Oaks, CA (US)
PCT Filed Sep. 10, 2018, PCT No. PCT/US2018/050305 § 371(c)(1), (2) Date Mar. 31, 2020, PCT Pub. No. WO2019/055357, PCT Pub. Date Mar. 21, 2019.
Claims priority of provisional application 62/559,420, filed on Sep. 15, 2017.
Prior Publication US 2021/0369616 A1, Dec. 2, 2021
Int. Cl. A61K 9/19 (2006.01); A61K 38/19 (2006.01); A61K 39/395 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61K 47/40 (2006.01); C07K 14/52 (2006.01); C07K 16/28 (2006.01); C07K 16/32 (2006.01)

CPC A61K 9/19 (2013.01) [A61K 38/196 (2013.01); A61K 39/395 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/18 (2013.01); A61K 47/183 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61K 47/40 (2013.01); C07K 14/524 (2013.01); C07K 16/2809 (2013.01); C07K 16/2848 (2013.01); C07K 16/2863 (2013.01); C07K 16/2878 (2013.01); C07K 16/32 (2013.01)]

22 Claims

1. A process for making a lyophilized pharmaceutical formulation of a therapeutic protein, which comprises:

a. providing a formulation of a bulk amount of the therapeutic protein,

b. measuring the concentration of the therapeutic protein in said bulk formulation,

c. determining a fill weight of the bulk formulation according to the following formula to achieve a target fixed dose of the therapeutic protein in a container,

and

d. lyophilizing the formulation in the container.