	US 12,493,019 B2
	Methods of determining protein stability
Jie Wen, Thousand Oaks, CA (US)
Assigned to AMGEN INC., Thousand Oaks, CA (US)
Appl. No. 17/431,810
Filed by AMGEN INC., Thousand Oaks, CA (US)
PCT Filed Feb. 19, 2020, PCT No. PCT/US2020/018847 § 371(c)(1), (2) Date Aug. 18, 2021, PCT Pub. No. WO2020/172293, PCT Pub. Date Aug. 27, 2020.
Claims priority of provisional application 62/808,166, filed on Feb. 20, 2019.
Prior Publication US 2022/0137010 A1, May 5, 2022
Int. Cl. G01N 30/64 (2006.01); G01N 30/86 (2006.01); G01N 30/02 (2006.01)

CPC G01N 30/64 (2013.01) [G01N 30/8631 (2013.01); G01N 2030/027 (2013.01)]

8 Claims

1. A method of determining the stability of a therapeutic protein in a formulation, wherein the therapeutic protein is a monoclonal antibody, a bispecific T cell engager molecule, or an Fc fusion protein, the method comprising:

(a) exposing the formulation to a change in temperature;

(b) determining the thermal stability of the therapeutic protein at a single time point by measuring a thermal unfolding temperature T_mof the therapeutic protein in response to the change in temperature using differential scanning calorimetry (DSC) or differential scanning fluorimetry (DSF);

wherein the T_mvalue of the therapeutic protein indicates the stability of the therapeutic protein for at least 6 months.