Claims for Patent: 7,485,704

Summary for Patent: 7,485,704

Title:	Reducing protein A leaching during protein A affinity chromatography
Abstract:	A method for reducing leaching of protein A during protein A affinity chromatography is described which involves reducing temperature or pH of, or by adding one or more protease inhibitors to, a composition that is subjected to protein A affinity chromatography.
Inventor(s):	Fahrner; Robert L. (San Mateo, CA), Laverdiere; Amy (San Francisco, CA), McDonald; Paul J. (San Francisco, CA), O\'Leary; Rhona M. (San Francisco, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	10/877,532
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,485,704
Patent Claims:	1. A method of purifying a protein which comprises a C.sub.H2/C.sub.H3 region comprising: a. subjecting a composition comprising said protein to protein A affinity chromatography to provide a recovered composition and measuring leached protein A in said recovered composition; and b. if greater than about 20 ng protein A per mg of said protein is measured in said recovered composition, then performing subsequent purification of compositions comprising said protein by protein A affinity chromatography at a temperature in the range from about 3.degree. C. to about 18.degree. C., such that protein A leaching is reduced. 2. The method of claim 1 wherein the protein is an antibody. 3. The method of claim 2 wherein the antibody binds an antigen selected from the group consisting of HER2, vascular endothelial growth factor (VEGF), IgE, CD20, CD40, CD11a, tissue factor (TF), prostate stem cell antigen (PSCA), interleukin-8 (IL-8), epidermal growth factor receptor (EGFR), HER3, HER4, .alpha.4.beta.7 and .alpha.5.beta.3. 4. The method of claim 2 wherein the antibody is selected from the group consisting of Trastuzumab, humanized 2C4, humanized CD11a antibody, and humanized VEGF antibody. 5. The method of claim 2 wherein the antibody binds HER2 antigen. 6. The method of claim 5 wherein the antibody is Trastuzumab or humanized 2C4. 7. The method of claim 1 wherein the protein is an immunoadhesin. 8. The method of claim 7 wherein the immunoadhesin is a TNF receptor immunoadhesin. 9. The method of claim 1 further comprising exposing the composition subjected to protein A affinity chromatography to a protease inhibitor in order to reduce the protease activity. 10. The method of claim 9 wherein the protease inhibitor is EDTA or 4-(2-aminoethyl)-benzenesulfonyl-fluoride, hydrochloride (AEBSF). 11. The method of claim 1 further comprising adjusting the pH of the composition prior to protein A affinity chromatography to a pH in the range from about 2.5 to about 3.5. 12. A method of purifying a protein which comprises a C.sub.H2/C.sub.H3 region comprising: a. subjecting a composition comprising said protein to protein A affinity chromatography to provide a recovered composition and measuring leached protein A in said recovered composition; and b. if greater than about 20 ng protein A per mg of said protein is measured in said recovered composition, then performing subsequent purification of compositions comprising said protein by protein A affinity chromatography at a temperature in the range from about 10.degree. C. to about 18.degree. C., such that protein A leaching is reduced.

Details for Patent 7,485,704

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2039-02-26
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2039-02-26
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2039-02-26