	US 12,295,362 B2
	Formulations and processes for CAR T cell drug products
Muneeswara Babu Medi, Chalfont, PA (US); Zhuojin Xu, San Francisco, CA (US); Jung S. Lee, South San Francisco, CA (US); Yajin Ni, San Diego, CA (US); and Mark W. Leonard, Burlingame, CA (US)
Assigned to Allogene Therapeutics, Inc., South San Francisco, CA (US)
Filed by Allogene Therapeutics, Inc., South San Francisco, CA (US)
Filed on Feb. 3, 2022, as Appl. No. 17/592,105.
Claims priority of provisional application 63/145,235, filed on Feb. 3, 2021.
Prior Publication US 2022/0241329 A1, Aug. 4, 2022
Int. Cl. A01N 1/125 (2025.01); A61K 40/11 (2025.01); A61K 40/31 (2025.01); A61K 40/42 (2025.01); C12N 5/0783 (2010.01)

CPC A01N 1/125 (2025.01) [A61K 40/11 (2025.01); A61K 40/31 (2025.01); A61K 40/4211 (2025.01); C12N 5/0636 (2013.01)]

20 Claims

1. A process of preparing a drug product comprising engineered immune cells, said process comprising the steps of

(a) formulating engineered immune cells in a composition containing a cryopreservative to form a drug product, wherein the cryopreservative comprises DMSO, and

(b) filling while mixing in a spinner flask the drug product into one or more containers at room temperature for at least 30 minutes,

wherein the drug product maintains homogeneity when step (b) is extended to up to about two hours.