AR089787A1 - Formulaciones estabilizadas que contienen anticuerpos anti-ang2 - Google Patents
Formulaciones estabilizadas que contienen anticuerpos anti-ang2Info
- Publication number
- AR089787A1 AR089787A1 ARP130100204A ARP130100204A AR089787A1 AR 089787 A1 AR089787 A1 AR 089787A1 AR P130100204 A ARP130100204 A AR P130100204A AR P130100204 A ARP130100204 A AR P130100204A AR 089787 A1 AR089787 A1 AR 089787A1
- Authority
- AR
- Argentina
- Prior art keywords
- seq
- antibody
- pharmaceutical formulation
- ang
- antibodies
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Abstract
Formulaciones farmacéuticas que comprenden un anticuerpo que se une específicamente a angiopoyetina 2 (Ang-2). Las formulaciones pueden contener, además de un anticuerpo anti-Ang-2, al menos un aminoácido, al menos un carbohidrato, o al menos un tensioactivo no iónico. Las formulaciones farmacéuticas exhiben un grado sustancial de estabilidad del anticuerpo tras el almacenamiento durante varios meses y después de haber sido sometido a esfuerzo térmico y a otros esfuerzos físicos. Reivindicación 1: Una formulación farmacéutica que comprende: (i) un anticuerpo que se une específicamente a angiopoyetina 2 humana (Ang-2 humana); (ii) un tampón a un pH de 6,0 ± 0,3; (iii) un detergente no iónico; y (iv) un estabilizador. Reivindicación 2: La formulación farmacéutica de la reivindicación 1, en la que el anticuerpo comprende una HCDR1 de SEQ ID Nº 4, una HCDR2 de SEQ ID Nº 6, una HCDR3 de SEQ ID Nº 8, una LCDR1 de SEQ ID Nº 12, una LCDR2 de SEQ ID Nº 14, y una LCDR3 de SEQ ID Nº 16. Reivindicación 3: La formulación farmacéutica de cualquiera de las reivindicaciones 1 y 2, en la que el anticuerpo comprende un HCVD de SEQ ID Nº 18 y un LCVD de SEQ ID Nº 20. Reivindicación 5: La formulación farmacéutica de cualquiera de las reivindicaciones 1 - 4, en la que la concentración de anticuerpo es de alrededor de 25 mg/mL ± 0,375 mg/mL, o alrededor de 50 mg/mL ± 7,5 mg/mL. Reivindicación 32: Una formulación farmacéutica que comprende (a) 25 mg/mL ± 3,75 mg/mL de un anticuerpo anti-Ang-2, (b) histidina 10 mM ± 1,5 mM, pH 6 ± 0,3, (c) 0,2% p/v ± 0,03% de polisorbato 20, y (d) 10% p/v ± 1,5% de sacarosa, en la que: (a) el anticuerpo comprende un HCVD de SEQ ID Nº 18 y un LCVD de SEQ ID Nº 20; (b) más de un 96% de los anticuerpos tienen un peso molecular de 151 kDa ± 1 kDa; (c) al menos un 53% de los anticuerpos tienen un punto isoeléctrico de alrededor de 8,13 ± 0,01; y (d) de alrededor del 90% a alrededor del 92% de los anticuerpos están fucosilados.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261589427P | 2012-01-23 | 2012-01-23 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR089787A1 true AR089787A1 (es) | 2014-09-17 |
Family
ID=47633582
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP130100204A AR089787A1 (es) | 2012-01-23 | 2013-01-23 | Formulaciones estabilizadas que contienen anticuerpos anti-ang2 |
Country Status (23)
Country | Link |
---|---|
US (1) | US9402898B2 (es) |
EP (1) | EP2807190B1 (es) |
JP (1) | JP6113756B2 (es) |
KR (1) | KR102063028B1 (es) |
CN (1) | CN104169299B (es) |
AR (1) | AR089787A1 (es) |
AU (1) | AU2013212587B2 (es) |
BR (1) | BR112014017882A2 (es) |
CA (1) | CA2861062A1 (es) |
CL (1) | CL2014001930A1 (es) |
EA (1) | EA033387B1 (es) |
HK (1) | HK1204631A1 (es) |
IL (1) | IL233482B (es) |
JO (1) | JO3533B1 (es) |
MA (1) | MA35904B1 (es) |
MX (1) | MX357393B (es) |
MY (1) | MY164611A (es) |
NZ (1) | NZ627859A (es) |
PH (1) | PH12014501628B1 (es) |
SG (1) | SG11201403792TA (es) |
TW (1) | TWI615149B (es) |
UY (1) | UY34587A (es) |
WO (1) | WO2013112438A1 (es) |
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IT1396433B1 (it) * | 2009-11-16 | 2012-11-23 | Rolic Invest Sarl | Impianto eolico per la generazione di energia elettrica e metodo per realizzare un pilone del suddetto impianto eolico. |
CA2781467C (en) | 2009-11-20 | 2015-10-13 | Biocon Limited | Formulations of antibody |
JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
KR101867279B1 (ko) | 2010-10-06 | 2018-06-15 | 리제너론 파아마슈티컬스, 인크. | 항―인터류킨―4 수용체(il-4r) 항체를 함유하는 안정화된 제형 |
MX357393B (es) | 2012-01-23 | 2018-07-06 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti - ang2. |
US8613919B1 (en) * | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
-
2013
- 2013-01-22 MX MX2014008874A patent/MX357393B/es active IP Right Grant
- 2013-01-22 BR BR112014017882A patent/BR112014017882A2/pt not_active Application Discontinuation
- 2013-01-22 WO PCT/US2013/022473 patent/WO2013112438A1/en active Application Filing
- 2013-01-22 US US13/746,669 patent/US9402898B2/en active Active
- 2013-01-22 KR KR1020147023205A patent/KR102063028B1/ko active IP Right Grant
- 2013-01-22 CA CA2861062A patent/CA2861062A1/en not_active Abandoned
- 2013-01-22 NZ NZ627859A patent/NZ627859A/en not_active IP Right Cessation
- 2013-01-22 CN CN201380006367.8A patent/CN104169299B/zh not_active Expired - Fee Related
- 2013-01-22 EP EP13702556.5A patent/EP2807190B1/en active Active
- 2013-01-22 AU AU2013212587A patent/AU2013212587B2/en not_active Ceased
- 2013-01-22 EA EA201491414A patent/EA033387B1/ru unknown
- 2013-01-22 JP JP2014553508A patent/JP6113756B2/ja not_active Expired - Fee Related
- 2013-01-22 MY MYPI2014001985A patent/MY164611A/en unknown
- 2013-01-22 JO JOP/2013/0020A patent/JO3533B1/ar active
- 2013-01-22 SG SG11201403792TA patent/SG11201403792TA/en unknown
- 2013-01-23 AR ARP130100204A patent/AR089787A1/es not_active Application Discontinuation
- 2013-01-23 TW TW102102503A patent/TWI615149B/zh not_active IP Right Cessation
- 2013-01-23 UY UY0001034587A patent/UY34587A/es not_active Application Discontinuation
-
2014
- 2014-07-02 IL IL233482A patent/IL233482B/en active IP Right Grant
- 2014-07-15 PH PH12014501628A patent/PH12014501628B1/en unknown
- 2014-07-22 CL CL2014001930A patent/CL2014001930A1/es unknown
- 2014-08-07 MA MA37279A patent/MA35904B1/fr unknown
-
2015
- 2015-06-01 HK HK15105209.9A patent/HK1204631A1/xx unknown
Also Published As
Publication number | Publication date |
---|---|
AU2013212587A1 (en) | 2014-08-21 |
EA033387B1 (ru) | 2019-10-31 |
KR102063028B1 (ko) | 2020-01-07 |
SG11201403792TA (en) | 2014-10-30 |
PH12014501628A1 (en) | 2014-10-13 |
IL233482B (en) | 2019-06-30 |
CN104169299B (zh) | 2018-06-05 |
UY34587A (es) | 2013-07-31 |
MX357393B (es) | 2018-07-06 |
PH12014501628B1 (en) | 2014-10-13 |
MX2014008874A (es) | 2014-09-01 |
NZ627859A (en) | 2015-09-25 |
CA2861062A1 (en) | 2013-08-01 |
US20130186797A1 (en) | 2013-07-25 |
MA35904B1 (fr) | 2014-12-01 |
HK1204631A1 (en) | 2015-11-27 |
IL233482A0 (en) | 2014-08-31 |
CN104169299A (zh) | 2014-11-26 |
TW201343177A (zh) | 2013-11-01 |
AU2013212587B2 (en) | 2017-07-20 |
WO2013112438A1 (en) | 2013-08-01 |
EP2807190A1 (en) | 2014-12-03 |
JO3533B1 (ar) | 2020-07-05 |
US9402898B2 (en) | 2016-08-02 |
MY164611A (en) | 2018-01-30 |
TWI615149B (zh) | 2018-02-21 |
KR20150000873A (ko) | 2015-01-05 |
EP2807190B1 (en) | 2018-12-26 |
CL2014001930A1 (es) | 2014-10-03 |
JP6113756B2 (ja) | 2017-04-12 |
BR112014017882A2 (pt) | 2017-06-27 |
EA201491414A1 (ru) | 2014-12-30 |
JP2015505539A (ja) | 2015-02-23 |
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