	US 12,303,483 B2
	Lipase degradation resistant surfactants for use in large molecule therapeutic formulations
Steven LaBrenz, Exton, PA (US); and Patrick Stahl, Exton, PA (US)
Assigned to Janssen Biotech, Inc., Horsham, PA (US)
Filed by Janssen Biotech, Inc., Horsham, PA (US)
Filed on May 2, 2022, as Appl. No. 17/734,523.
Application 17/734,523 is a continuation of application No. 16/547,237, filed on Aug. 21, 2019, abandoned.
Claims priority of provisional application 62/721,884, filed on Aug. 23, 2018.
Prior Publication US 2022/0265596 A1, Aug. 25, 2022
Int. Cl. A61K 31/25 (2006.01); A61K 38/46 (2006.01)

CPC A61K 31/25 (2013.01) [A61K 38/465 (2013.01); C12Y 301/01001 (2013.01)]

14 Claims

1. A biological composition comprising:

about 20 mg/mL to about 200 mg/mL of a protein;

a pharmaceutically acceptable carrier; and

one or more polyethoxylated fatty alcohol (PFA) surfactants, wherein said one or more PFA surfactants is resistant to lipase degradation,

wherein said biological composition comprises a lipase/esterase activity that is ≥0.1 unit/mL of purified porcine esterase, and

wherein the protein is a non-recombinant, serum isolated protein, or a recombinant protein, wherein the protein was produced in a cell line selected from the group consisting of Chinese hamster ovary (CHO) cell line, PER.C6 cell line, and Sp2/0 cell line.