Claims for Patent: 9,920,114

Summary for Patent: 9,920,114

Title:	Antibody formulations
Abstract:	Described herein are anti-sclerostin antibody crystals, methods of making such antibody crystals and formulations comprising the antibody crystals.
Inventor(s):	Mason; Bruce D. (Simi Valley, CA), Zhang; Jifeng (Newbury Park, CA), Remmele, Jr.; Richard L. (Camarillo, CA)
Assignee:	AMGEN INC. (Thousand Oaks, CA)
Application Number:	15/460,961
Patent Claims:	1. A crystal of an anti-sclerostin IgG antibody comprising two light variable chains each comprised of SEQ ID NO: 23 and two heavy variable chains each comprised of SEQ ID NO: 25, wherein the crystal has a length of about 100 .mu.m to about 1000 .mu.m and an ellipsoidal shape. 2. The crystal of claim 1, wherein the antibody comprises two light and two heavy chains set forth in SEQ ID NOs: 33 and 35, respectively. 3. The crystal of claim 1, wherein the crystal comprises a salt selected from the group consisting of potassium phosphate and histidine. 4. A sterile formulation comprising the crystal of an anti-sclerostin IgG antibody two light variable chains each comprised of SEQ ID NO: 23 and two heavy variable chains each comprised of SEQ ID NO: 25, wherein the crystal has a length of about 100 .mu.m to about 1000 .mu.m and a shape of ellipsoidal, needle, rod or mixtures thereof. 5. The formulation of claim 4, wherein the antibody comprises two light and two heavy chains set forth in SEQ ID NOs: 33 and 35, respectively. 6. The formulation of claim 4, wherein the crystal comprises a salt selected from the group consisting of potassium phosphate and histidine. 7. A method of making the crystal of claim 1 comprising combining a solution of an anti-sclerostin IgG antibody comprising two light and two heavy chain variable regions of SEQ ID NOs: 23 and 25, respectively, with a crystallization reagent comprising a salt selected from the group consisting of potassium phosphate and histidine at pH 7-8. 8. The method of claim 7, wherein the concentration of salt in the crystallization buffer is from about 10 mM. 9. An anti-sclerostin antibody crystal produced by the method of claim 7, which has a length of about 100 .mu.m to about 1000 .mu.m and a shape of ellipsoidal, needle, rod or mixtures thereof. 10. The formulation of claim 4, that is a lyophilized formulation. 11. The formulation of claim 4, that is a liquid formulation. 12. The formulation of claim 4, wherein the crystal comprises a salt selected from the group consisting of potassium phosphate and histidine. 13. A method of reconstituting the lyophilized formulation of claim 10, comprising contacting the lyophilized formulation with about 0.5-2 mL of sterile diluent. 14. A method of increasing bone mineral density in a mammalian subject in need thereof comprising administering the formulation of claim 4, in an amount effective to increase bone mineral density in the subject.

Details for Patent 9,920,114

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2031-03-25