Claims for Patent: 8,008,447

Summary for Patent: 8,008,447

Title:	Crystallization of antibody or fragment thereof
Abstract:	The present disclosure concerns methods of crystallization and/or concentration of antibody or antibody fragments. The methods comprise contacting an antibody or antibody fragment with a solution comprising a salt of a divalent cation. Crystals and/or protein gels of antibody or antibody fragments are useful in compositions and formulations.
Inventor(s):	Hagewiesche; Annette Marie Clasen (Carlsbad, CA), Fukami; Julie (Woodside, CA), Cromwell; Mary E. M. (Redwood City, CA), Dinges; Rachel Bulotsky (San Mateo, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	11/572,369
Patent Claims:	1. A method for producing crystals of an anti-VEGF antibody comprising: a) contacting said anti-VEGF antibody with a solution that comprises about 5 to 120 mM ZnCl.sub.2 and about 1 to 100 mM sodium acetate buffer at a pH of about 4.7 to 5.7; and b) incubating the anti-VEGF antibody and the solution until crystals of the antibody are formed, wherein said anti-VEGF antibody is bevacizumab. 2. The method of claim 1, wherein the ZnCl.sub.2 is about 10 mM to 80 mM. 3. The method of claim 2, wherein the ZnCl.sub.2 is about 25 mM to 60 mM. 4. The method of claim 1, wherein the buffer comprises about 1 mM to 20 mM NaOAc. 5. The method of claim 1, wherein the buffer comprises about 25 mM to 75 mM NaOAc. 6. The method of claim 1, wherein the solution comprises more than about 10 mM ZnCl2 and more than about 5 mM NaOAc. 7. The method of claim 6, wherein the solution comprises about 100 mM ZnCl2 and about 10 mM NaOAc. 8. The method of claim 1, wherein the contacting is at ambient temperature. 9. A method for producing crystals of an anti-VEGF antibody comprising: a) contacting said anti-VEGF antibody with a solution that comprises about 5 to 100 mM MgCl.sub.2 and about 1 to 100 mM Tris buffer at a pH of about 9.0; and b) incubating the anti-VEGF antibody-and the solution until crystals of the antibody are formed, wherein said anti-VEGF antibody is bevacizumab. 10. The method of claim 9, wherein the Tris buffer is about 10 mM. 11. The method of claim 9, wherein the MgCl.sub.2 is about 50 mM to 100 mM. 12. The method of claim 9, wherein the contacting is at 2-8.degree. C. 13. The method of claim 9, wherein the contacting is at ambient temperature.

Details for Patent 8,008,447

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2024-07-23