Antibody formulations
Described herein are anti-sclerostin antibody crystals, methods of making such antibody crystals and formulations comprising the antibody crystals.
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 μm to about 1000 μm 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 μm to about 1000 μm 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 μm to about 1000 μm 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.