Sclerostin antibody crystals and formulations thereof
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
C07K-016/18
A61K-039/35
C07K-016/22
A61K-039/395
A61K-039/00
출원번호
US-0832268
(2015-08-21)
등록번호
US-9617333
(2017-04-11)
발명자
/ 주소
Clogston, Christi L.
Christian, Twinkle R.
Osslund, Timothy D.
Freeman, Elisabeth
출원인 / 주소
AMGEN INC.
대리인 / 주소
Marshall, Gerstein & Borun LLP
인용정보
피인용 횟수 :
0인용 특허 :
56
초록
Described herein are anti-sclerostin antibody crystals, methods of making such antibody crystals and formulations comprising the antibody crystals.
대표청구항▼
1. A crystal of an anti-sclerostin IgG antibody comprising two light chains each comprised of SEQ ID NO: 3 and two heavy chains each comprised of SEQ ID NO: 5, wherein said crystals have a length of up to 500μM and a shape selected from the group consisting of ellipsoids, rods and needles or mixture
1. A crystal of an anti-sclerostin IgG antibody comprising two light chains each comprised of SEQ ID NO: 3 and two heavy chains each comprised of SEQ ID NO: 5, wherein said crystals have a length of up to 500μM and a shape selected from the group consisting of ellipsoids, rods and needles or mixtures thereof. 2. A sterile formulation comprising the crystal of claim 1. 3. The formulation of claim 2, wherein the crystal comprises a salt selected from the group consisting of sodium dihydrogen phosphate, di-potassium hydrogen phosphate, sodium chloride, ammonium sulfate, potassium sodium tartrate tetrahydrate, tacsimate, sodium citrate dihydrate, sodium acetate trihydrate, di-ammonium tartrate, sodium malonate, acetate, calcium acetate, cacodylate, CHES, lithium sulfate, magnesium chloride, zinc acetate, cesium chloride, ammonium phosphate, sodium phosphase, potassium phosphate, sodium fluoride, potassium iodide, sodium idodide, ammonium iodide, sodium thiocyanate, potassium thiocyanate, sodium formate, potassium formate and ammonium formate. 4. The formulation of claim 2, that is a lyophilized formulation. 5. The formulation of claim 2, that is a liquid formulation. 6. The formulation of claim 5, comprising a concentration of at least about 100 mg of said antibody per ml of formulation. 7. The formulation of claim 5, comprising at least about 140 mg of antibody dispersed in 1.5 ml or less of liquid. 8. The formulation of claim 7 that is injectable through a syringe having a 20 Gauge needle or finer using a clinically acceptable amount of force. 9. A container comprising at least 50 mg of the antibody crystal of claim 1 for suspension in a volume of 0.5-2 mL. 10. A container comprising the formulation of claim 2. 11. A method of making acrystal of an anti-sclerostin IgG antibody comprising two light chains each comprised of SEQ ID NO: 3 and two heavy chains each comprised of SEQ ID NO: 5 , wherein said crystals have a length of up to 500 μm and a shape selected from the group consisting of ellipsoids, rods and needles or mixtures thereof, the method comprising combining a solution of the antibody with a crystallization reagent comprising a salt selected from the group consisting of sodium dihydrogen phosphate, di-potassium hydrogen phosphate, sodium chloride, ammonium sulfate, ammonium acetate, potassium sodium tartrate tetrahydrate, tacsimate, sodium citrate dihydrate, sodium acetate trihydrate, di-ammonium tartrate, sodium malonate, acetate, calcium acetate, cacodylate, CHES, lithium sulfate, lithium acetate dihydrate, magnesium chloride, magnesium acetate tetrahydrate, magnesium formate, magnesium nitrate, magnesium sulfate, zinc acetate, zinc chloride, zinc sulfate, cesium chloride, ammonium phosphate, sodium phosphase, potassium phosphate, sodium fluoride, potassium iodide, sodium idodide, ammonium iodide, sodium thiocyanate, potassium thiocyanate, sodium formate, potassium formate and ammonium formate, optionally at pH of about 6 to about 8, such that a crystal is formed. 12. The method of claim 11, wherein the concentration of the salt is from about 0.1 M to about 10 M. 13. A method of increasing bone mineral density, treating a disorder associated with decreased bone density, treating a bone-related disorder, or improving outcomes in a procedure, replacement, graft, surgery or repair in a mammalian subject comprising administering the formulation of claim 2 in an amount effective to increase bone mineral density in the subject.
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