AR099084A2 - ANTI-CTLA-4 ANTIBODY COMPOSITIONS - Google Patents
ANTI-CTLA-4 ANTIBODY COMPOSITIONSInfo
- Publication number
- AR099084A2 AR099084A2 ARP150100081A ARP150100081A AR099084A2 AR 099084 A2 AR099084 A2 AR 099084A2 AR P150100081 A ARP150100081 A AR P150100081A AR P150100081 A ARP150100081 A AR P150100081A AR 099084 A2 AR099084 A2 AR 099084A2
- Authority
- AR
- Argentina
- Prior art keywords
- amino acid
- composition
- antibody
- acid sequence
- chelating agent
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 15
- 229940045513 CTLA4 antagonist Drugs 0.000 title abstract 5
- 125000003275 alpha amino acid group Chemical group 0.000 abstract 10
- 239000002738 chelating agent Substances 0.000 abstract 7
- 239000007788 liquid Substances 0.000 abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 abstract 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 abstract 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 abstract 2
- 101000889276 Homo sapiens Cytotoxic T-lymphocyte protein 4 Proteins 0.000 abstract 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 2
- 102000043321 human CTLA4 Human genes 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 2
- 229920000053 polysorbate 80 Polymers 0.000 abstract 2
- 229940068968 polysorbate 80 Drugs 0.000 abstract 2
- 102000008203 CTLA-4 Antigen Human genes 0.000 abstract 1
- 108010021064 CTLA-4 Antigen Proteins 0.000 abstract 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 230000001613 neoplastic effect Effects 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- 239000012929 tonicity agent Substances 0.000 abstract 1
Landscapes
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
Composiciones de anticuerpos anti-CTLA4 que comprenden un agente quelante. Un método de tratamiento de enfermedades y afecciones con composiciones de anticuerpos CTLA-4, que incluyen diversas afecciones neoplásicas. Reivindicación 1: Una composición que comprende: un agente quelante y al menos un anticuerpo que comprende : una secuencia de aminoácidos que es al menos 90% idéntica a una secuencia de aminoácidos de cadena pesada que se muestra en la SEC ID Nº 2, y una secuencia de aminoácidos que es al menos 90% idéntica a una secuencia de aminoácidos de cadena liviana que se muestra en la SEC ID Nº 4, donde el anticuerpo se une al CTLA-4 humano. Reivindicación 5: La composición de acuerdo con la reivindicación 1, donde el anticuerpo comprende un anticuerpo monoclonal IgG2 anti-CTLA-4 que tiene las secuencias de aminoácidos de cadena pesada y liviana de ticilimumab. Reivindicación 10: La composición de acuerdo con la reivindicación 1, donde la composición comprende: un agente quelante, un buffer y un tensioactivo y un agente de tonicidad. Reivindicación 14: La composición de acuerdo con la reivindicación 1, donde la composición comprende: EDTA, histidina, polisorbato 80 y trehalosa. Reivindicación 18: La composición de acuerdo con la reivindicación 1, donde la composición comprende: de aproximadamente 0,1 mg/ml a aproximadamente 100 mg/ml de anticuerpo, de aproximadamente 0,001 mg/ml a aproximadamente 1,0 mg/ml de EDTA; histidina de aproximadamente 1 mM a aproximadamente 50 mM; de aproximadamente 0,01 mg/ml a aproximadamente 5 mg/ml de polisorbato 80; y de aproximadamente 10 mg/ml a aproximadamente 200 mg/ml de trehalosa. Reivindicación 21: Una composición estable que comprende al menos un anticuerpo anti- CTLA-4 monoclonal y un agente quelante, donde después la composición se conserva durante un período de aproximadamente 24 semanas a una temperatura de aproximadamente 40ºC; la disminución entre un área agregada del pico del cromatograma para la composición farmacéutica líquida estable que comprende los anticuerpos monoclonales anti-MIA-4 y el agente quelante; y un área agregada del pico del cromatograma para otra composición idéntica que carece del agente quelante que se conserva durante un periodo de aproximadamente 24 semanas a una temperatura de aproximadamente 40ºC, es de al menos aproximadamente 2%. Reivindicación 22: Un proceso para la preparación de una composición farmacéutica líquida que comprende mezclar al menos un anticuerpo anti-CTLA-4 que tiene la secuencia de aminoácidos de cadena pesada y liviana de ticilimumab en solución con al menos un agente quelante. Reivindicación 25: Una composición farmacéutica líquida que comprende: al menos una secuencia de aminoácidos que es al menos 95% idéntica a una secuencia de aminoácido de cadena pesada que se muestra en la SEC ID Nº 2, y comprende además una secuencia de aminoácidos que es al menos 95% idéntica a una secuencia de aminoácido de cadena liviana que se muestra en la SEC ID Nº 4, donde el anticuerpo se une al CTLA-4 humano; y un excipiente aceptable para uso farmacéutico, donde la composición contiene una concentración de anticuerpo que es de al menos aproximadamente 10 mg/ml.Compositions of anti-CTLA4 antibodies comprising a chelating agent. A method of treating diseases and conditions with CTLA-4 antibody compositions, which include various neoplastic conditions. Claim 1: A composition comprising: a chelating agent and at least one antibody comprising: an amino acid sequence that is at least 90% identical to a heavy chain amino acid sequence shown in SEQ ID NO: 2, and a amino acid sequence that is at least 90% identical to a light chain amino acid sequence shown in SEQ ID NO: 4, where the antibody binds to human CTLA-4. Claim 5: The composition according to claim 1, wherein the antibody comprises an anti-CTLA-4 IgG2 monoclonal antibody having the heavy and light chain amino acid sequences of ticilimumab. Claim 10: The composition according to claim 1, wherein the composition comprises: a chelating agent, a buffer and a surfactant and a tonicity agent. Claim 14: The composition according to claim 1, wherein the composition comprises: EDTA, histidine, polysorbate 80 and trehalose. Claim 18: The composition according to claim 1, wherein the composition comprises: from about 0.1 mg / ml to about 100 mg / ml of antibody, from about 0.001 mg / ml to about 1.0 mg / ml of EDTA ; histidine from about 1 mM to about 50 mM; from about 0.01 mg / ml to about 5 mg / ml polysorbate 80; and from about 10 mg / ml to about 200 mg / ml trehalose. Claim 21: A stable composition comprising at least one monoclonal anti-CTLA-4 antibody and a chelating agent, wherein the composition is then stored for a period of about 24 weeks at a temperature of about 40 ° C; the decrease between an aggregate area of the chromatogram peak for the stable liquid pharmaceutical composition comprising the anti-MIA-4 monoclonal antibodies and the chelating agent; and an aggregate area of the chromatogram peak for another identical composition that lacks the chelating agent that is preserved for a period of about 24 weeks at a temperature of about 40 ° C, is at least about 2%. Claim 22: A process for the preparation of a liquid pharmaceutical composition comprising mixing at least one anti-CTLA-4 antibody having the heavy and light chain amino acid sequence of ticilimumab in solution with at least one chelating agent. Claim 25: A liquid pharmaceutical composition comprising: at least one amino acid sequence that is at least 95% identical to a heavy chain amino acid sequence shown in SEQ ID NO: 2, and further comprises an amino acid sequence that is at least 95% identical to a light chain amino acid sequence shown in SEQ ID No. 4, where the antibody binds to human CTLA-4; and an excipient acceptable for pharmaceutical use, wherein the composition contains an antibody concentration that is at least about 10 mg / ml.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US65976605P | 2005-03-08 | 2005-03-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR099084A2 true AR099084A2 (en) | 2016-06-29 |
Family
ID=39488251
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP150100081A AR099084A2 (en) | 2005-03-08 | 2015-01-13 | ANTI-CTLA-4 ANTIBODY COMPOSITIONS |
Country Status (3)
| Country | Link |
|---|---|
| CN (2) | CN101325968B (en) |
| AR (1) | AR099084A2 (en) |
| ZA (2) | ZA200707194B (en) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI0921320A2 (en) * | 2008-11-28 | 2018-05-22 | Abbott Laboratories | stable antibody compositions and methods for stabilizing them |
| EP3053572A1 (en) * | 2015-02-06 | 2016-08-10 | Ares Trading S.A. | Liquid pharmaceutical composition |
| DK3283107T3 (en) * | 2015-04-17 | 2020-08-31 | Bristol Myers Squibb Co | COMPOSITIONS INCLUDING A COMBINATION OF IPILIMUMAB AND NIVOLUMAB |
| CN106620691B (en) * | 2015-11-04 | 2020-08-21 | 信达生物制药(苏州)有限公司 | Recombinant fully human anti-CTLA-4 monoclonal antibody preparation and application thereof |
| CN106913869B (en) * | 2017-03-17 | 2020-07-28 | 信达生物制药(苏州)有限公司 | A kind of anti-CTLA-4 monoclonal antibody preparation and its application |
| EA202090286A1 (en) * | 2017-07-14 | 2020-05-12 | Пфайзер, Инк. | ANTIBODIES TO MAdCAM |
| CN114679909A (en) * | 2019-05-20 | 2022-06-28 | 潘迪恩运营公司 | MAdCAM-targeted immune tolerance |
| MX2021014804A (en) | 2019-06-04 | 2022-01-18 | Jiangsu Hengrui Medicine Co | Antibody capable of binding to thymic stromal lymphopoietin and use thereof. |
| US20230203164A1 (en) * | 2019-12-25 | 2023-06-29 | Bio-Thera Solutions, Ltd. | Anti-ctla-4 monoclonal antibody, preparation method therefor, and application thereof |
| CN113712906A (en) * | 2020-05-20 | 2021-11-30 | 百奥泰生物制药股份有限公司 | anti-CTLA-4 antibody formulations and uses thereof |
| CN113024670A (en) * | 2019-12-25 | 2021-06-25 | 百奥泰生物制药股份有限公司 | CTLA-4 antibody and preparation method thereof |
| CN111410688A (en) * | 2020-03-13 | 2020-07-14 | 苏州智享众创孵化管理有限公司 | Separation and purification method for improving purity of bispecific antibody |
| KR20230116857A (en) * | 2020-12-03 | 2023-08-04 | 지앙수 헨그루이 파마슈티컬스 컴퍼니 리미티드 | Pharmaceutical compositions of anti-TSLP antibodies and uses thereof |
| CN112569183B (en) * | 2020-12-11 | 2022-12-09 | 上海赛金生物医药有限公司 | Preparation of anti-CTLA-4 antibody and fusion protein |
| CN115282281B (en) * | 2022-09-28 | 2022-12-13 | 智泽童康(广州)生物科技有限公司 | Application of iron death inhibitor in preparation of medicine for preventing and treating biliary tract diseases |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7452539B2 (en) * | 2001-12-19 | 2008-11-18 | Genentech, Inc. | Stabilizing polypeptides which have been exposed to urea |
-
2006
- 2006-03-02 CN CN200680015670.4A patent/CN101325968B/en active Active
- 2006-03-02 CN CNA2006800136236A patent/CN101193917A/en active Pending
-
2007
- 2007-08-24 ZA ZA200707194A patent/ZA200707194B/en unknown
- 2007-08-28 ZA ZA200707293A patent/ZA200707293B/en unknown
-
2015
- 2015-01-13 AR ARP150100081A patent/AR099084A2/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ZA200707194B (en) | 2008-07-30 |
| CN101325968B (en) | 2014-04-23 |
| CN101193917A (en) | 2008-06-04 |
| ZA200707293B (en) | 2009-04-29 |
| CN101325968A (en) | 2008-12-17 |
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