[특허]Protein formulation

Protein formulation 원문보기

IPC분류정보
국가/구분	United States(US) Patent 등록
국제특허분류(IPC7판)	A61K-039/395
출원번호	UP-0441994 (2006-05-26)
등록번호	US-7682609 (2010-04-21)
발명자 / 주소	Andya, James Cleland, Jeffrey L. Hsu, Chung C. Lam, Xanthe M. Overcashier, David E. Shire, Steven J. Yang, Janet Yu-Feng Wu, Sylvia Sau-Yan
출원인 / 주소	Genentech, Inc.
대리인 / 주소	Agarwal, Esq., Atulya
인용정보	피인용 횟수 : 21 인용 특허 : 113

초록 ▼

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

대표청구항 ▼

What is claimed is: 1. A formulation comprising a lyophilized mixture of a recombinant humanized HER2 monoclonal antibody, a lyoprotectant, and a buffer. 2. The formulation of claim 1 wherein the pH of the formulation is from 5-7. 3. The formulation of claim 2 wherein the pH of the formulation is 6.0. 4. The formulation of claim 1 wherein the buffer is histidine, phosphate, Tris, citrate, succinate, or other organic acid. 5. The formulation of claim 4 wherein the buffer is histidine. 6. The formulation of claim 1 wherein the antibody is huMAb4D5-8. 7. The formulation of claim 1 further comprising a surfactant. 8. The formulation of claim 7 wherein the surfactant is a nonionic surfactant. 9. The formulation of claim 7 wherein the surfactant is a polysorbate. 10. The formulation of claim 1 wherein the lyoprotectant is a sugar. 11. The formulation of claim 1 which is stable at 30° C. for at least 6 months. 12. The formulation of claim 1 wherein the concentration of the humanized HER2 antibody is from about 5-40 mg/mL. 13. The formulation of claim 12 wherein the concentration of the humanized HER2 antibody is from about 20-30 mg/mL. 14. A vial containing a formulation comprising a lyophilized mixture of a recombinant humanized HER2 monoclonal antibody, a lyoprotectant, and a buffer. 15. The vial of claim 14 which is a 3, 5, 10, 20, 50, or 100 cc vial. 16. The vial of claim 14 wherein the antibody is huMAb4D5-8. 17. The vial of claim 14 wherein the pH of the formulation is from 5-7. 18. The vial of claim 17 wherein the pH of the formulation is 6.0. 19. The vial of claim 14 wherein the buffer is histidine, phosphate, Tris, citrate, succinate, or other organic acid. 20. A formulation comprising a lyophilized mixture of huMAb4D5-8 in an amount from 5-40 mg/mL, a sugar in an amount from 10-400 mM, a surfactant in an amount from 0.001-0.5%, and histidine buffer, wherein the pH of the formulation is 6.0. 21. A method of treating HER2 overexpressing breast cancer comprising administering to a patient with the breast cancer a reconstituted formulation comprising recombinant humanized HER2 antibody, wherein the reconstituted formulation has been prepared by reconstituting of claim 1 with a diluent to generate the reconstituted formulation. 22. The method as in claim 21 wherein the pH of the formulation is from 5-7. 23. The method as in claim 22 wherein the pH of the formulation is 6.0. 24. The method as in claim 21 wherein the buffer is histidine, phosphate, Tris, citrate, succinate, or other organic acid. 25. The method as in claim 21 wherein the concentration of the humanized HER2 antibody in the reconstituted formulation is from about 5-50 mg/mL. 26. The method as in claim 25 wherein the concentration of the humanized HER2 antibody in the reconstituted formulation is from about 10-40 mg/mL. 27. The method as in claim 21 wherein the antibody is huMAb4D5-8. 28. The method as in claim 21 wherein the pH of the reconstituted formulation 6.0. 29. The method as in claim 21 wherein the diluent is sterile water. 30. The method as in claim 21 wherein the diluent is bacteriostatic water for injection (BWFI).

이 특허에 인용된 특허 (113)

Jardieu Paula M. ; Presta Leonard G., Anti-IgE antibodies.
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King C. Richter (Washington DC) Kasprzyk Philip G. (Washington DC) Bird Robert E. (Rockville MD), Anti-erbB-2 antibodies, combinations thereof, and therapeutic and diagnostic uses thereof.
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Chang Tse-wen (Houston TX) Sun Bill N. (Houston TX) Sun Cecily R. (Houston TX), Anti-idiotype antibodies specific for the parotope of antibodies which bind to IgE-bearing B cells but not basophils.
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Shawver Laura K. ; Brandis John W. ; Mann Elaina ; Hancock Miriam E. C. ; Mischak Ronald P. ; Monahan John J., Anti-neoplastic drugs in cancer therapy.
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Bissery Marie-Christine,FRX, Anti-tumor compositions containing taxane derivatives.
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Vandlen Richard L. ; Holmes William E., Antibodies specific for heregulin 2-.alpha..
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Chang Tse W. (Houston TX), Antibodies to epitopes present on membrane-bound but not secreted IGA.
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Senter Peter D. (Seattle WA) Saulnier Mark G. (Middletown CT) Brown Joseph P. (Seattle WA) Kerr David E. (Seattle WA), Antibody-enzyme conjugates in combination with prodrugs for the delivery of cytotoxic agents to tumor cells.
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Arakawa Tsutomu ; Kita Yoshiko, Antibody-induced apoptosis.
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Ring David B., Antigen-binding sites of antibody molecules specific for cancer antigens.
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Chang Tse-Wen (Houston TX), Antigenic epitopes of IgE present on B cell but not basophil surface.
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Chang Tse-wen (Houston TX), Antigenic epitopes present on membrane-bound but not secreted IgE.
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Bissery Marie-Christine,FRX, Antitumour compositions containing taxane derivatives.
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Chang Tse-wen (Houston TX), Chimeric anti-human IgE-monoclonal antibody which binds to secreted IgE and membrane-bound IgE expressed by IgE-expressi.
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Capon Daniel J. (Hillsborough CA) Weiss Arthur (Mill Valley CA) Irving Brian A. (San Francisco CA) Roberts Margo R. (San Francisco CA) Zsebo Krisztina (Woodside CA), Chimeric chains for receptor-associated signal transduction pathways.
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Chang Tse W. (Houston TX), Chimeric monoclonal antibodies which bind to the extracellular segment of the membrane-bound domain of a human membrane-.
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Curry Willie M. (New Rochelle NY) Farb David L. (LaGrangeville NY), Composition of intravenous immune globulin.
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Greene Mark I. ; Qian Xiaolan, Compositions and methods of treating tumors.
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Greene Mark I. (Penn Valley PA) Zhang Xin (Philadelphia PA), Compounds that bind to p185 and methods of using the same.
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Leder Philip (Chestnut Hill MA) Shimizu Akira (Kyoto MD JPX) Siraganian Reuben (Bethesda MD) Benfey Philip (New York NY), DNA encoding IgE receptor alpha-subunit or fragment thereof.
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Huston James S. ; Houston L. L. ; Ring David B. ; Oppermann Hermann, DNA encoding biosynthetic binding protein for cancer marker.
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Chang Tse W. (Houston TX), DNA encoding murine-human chimeric antibodies specific for antigenic epitopes of IgE present on the extracellular segmen.
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Kraus Matthias H. (Bethesda MD) Aaronson Stuart A. (Vienna VA), DNA segment encoding a gene for a receptor related to the epidermal growth factor receptor.
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Carney Walter P. (North Andover MA) McKenzie Sara J. (Lynn MA), Detection and quantification of neu related proteins in the biological fluids of humans.
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Carney, Walter P.; McKenzie, Sara J.; Weinberg, Robert A., Detection of neu p185 in cell lysates.
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Bargmann Cornelia I. (Arlington MA) Weinberg Robert A. (Brookline MA), Detection of point mutations in neu genes.
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Slamon Dennis J. (Woodland Hills CA) McGuire William L. (San Antonio TX), Determination of status in neoplastic disease.
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Cleland Jeffrey L. (San Carlos CA) Jones Andrew J. S. (San Mateo CA), Excipient stabilization of polypeptides treated with organic solvents.
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Chang Tse W. (Houston TX), Extracellular segments of human e 상세보기

IPC	Description
A	생활필수품
A62	인명구조; 소방(사다리 E06C)
A62B	인명구조용의 기구, 장치 또는 방법(특히 의료용에 사용되는 밸브 A61M 39/00; 특히 물에서 쓰이는 인명구조 장치 또는 방법 B63C 9/00; 잠수장비 B63C 11/00; 특히 항공기에 쓰는 것, 예. 낙하산, 투출좌석 B64D; 특히 광산에서 쓰이는 구조장치 E21F 11/00)
A62B-1/08	.. 윈치 또는 풀리에 제동기구가 있는 것

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Protein formulation 원문보기

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Protein formulation 원문보기

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이 특허에 인용된 특허 (113)

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