US20110226650A1 - Antibody formulation - Google Patents

Antibody formulation Download PDF

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Publication number
US20110226650A1
US20110226650A1 US12/973,640 US97364010A US2011226650A1 US 20110226650 A1 US20110226650 A1 US 20110226650A1 US 97364010 A US97364010 A US 97364010A US 2011226650 A1 US2011226650 A1 US 2011226650A1
Authority
US
United States
Prior art keywords
antibody
formulation
concentration
buffer
antibodies
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US12/973,640
Other languages
English (en)
Inventor
Yatin R. Gokarn
Timothy J. Kamerzell
Megan Li
Mary Cromwell
Hong Liu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
Genentech Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Genentech Inc filed Critical Genentech Inc
Priority to US12/973,640 priority Critical patent/US20110226650A1/en
Publication of US20110226650A1 publication Critical patent/US20110226650A1/en
Assigned to GENENTECH, INC. reassignment GENENTECH, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GOKARN, YATIN R., KAMERZELL, TIMOTHY J., LIU, HONG, CROMWELL, MARY, LI, MEGAN
Assigned to F. HOFFMANN LA-ROCHE AG reassignment F. HOFFMANN LA-ROCHE AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GENENTECH, INC.
Priority to US14/046,909 priority patent/US9226961B2/en
Priority to US14/952,551 priority patent/US20160251422A1/en
Priority to US15/658,306 priority patent/US20180171004A1/en
Priority to US16/798,211 priority patent/US20200392220A1/en
Abandoned legal-status Critical Current

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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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • 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
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
US12/973,640 2009-12-21 2010-12-20 Antibody formulation Abandoned US20110226650A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US12/973,640 US20110226650A1 (en) 2009-12-21 2010-12-20 Antibody formulation
US14/046,909 US9226961B2 (en) 2009-12-21 2013-10-04 Antibody formulation
US14/952,551 US20160251422A1 (en) 2009-12-21 2015-11-25 Antibody formulation
US15/658,306 US20180171004A1 (en) 2009-12-21 2017-07-24 Antibody formulation
US16/798,211 US20200392220A1 (en) 2009-12-21 2020-02-21 Antibody formulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28853509P 2009-12-21 2009-12-21
US12/973,640 US20110226650A1 (en) 2009-12-21 2010-12-20 Antibody formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/046,909 Continuation US9226961B2 (en) 2009-12-21 2013-10-04 Antibody formulation

Publications (1)

Publication Number Publication Date
US20110226650A1 true US20110226650A1 (en) 2011-09-22

Family

ID=43733329

Family Applications (5)

Application Number Title Priority Date Filing Date
US12/973,640 Abandoned US20110226650A1 (en) 2009-12-21 2010-12-20 Antibody formulation
US14/046,909 Active US9226961B2 (en) 2009-12-21 2013-10-04 Antibody formulation
US14/952,551 Abandoned US20160251422A1 (en) 2009-12-21 2015-11-25 Antibody formulation
US15/658,306 Abandoned US20180171004A1 (en) 2009-12-21 2017-07-24 Antibody formulation
US16/798,211 Abandoned US20200392220A1 (en) 2009-12-21 2020-02-21 Antibody formulation

Family Applications After (4)

Application Number Title Priority Date Filing Date
US14/046,909 Active US9226961B2 (en) 2009-12-21 2013-10-04 Antibody formulation
US14/952,551 Abandoned US20160251422A1 (en) 2009-12-21 2015-11-25 Antibody formulation
US15/658,306 Abandoned US20180171004A1 (en) 2009-12-21 2017-07-24 Antibody formulation
US16/798,211 Abandoned US20200392220A1 (en) 2009-12-21 2020-02-21 Antibody formulation

Country Status (19)

Country Link
US (5) US20110226650A1 (fr)
EP (2) EP2515941B1 (fr)
JP (3) JP6214161B2 (fr)
KR (3) KR20190067275A (fr)
CN (2) CN102770158B (fr)
AR (1) AR079556A1 (fr)
AU (1) AU2010339770B2 (fr)
BR (1) BR112012013093A2 (fr)
CA (1) CA2783846C (fr)
ES (1) ES2765657T3 (fr)
IL (1) IL219537B (fr)
MX (2) MX361668B (fr)
MY (1) MY159156A (fr)
PL (1) PL2515941T3 (fr)
RU (2) RU2017102553A (fr)
SG (3) SG181834A1 (fr)
TW (2) TWI623323B (fr)
WO (1) WO2011084750A1 (fr)
ZA (1) ZA201203242B (fr)

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WO2014049073A1 (fr) * 2012-09-27 2014-04-03 Octapharma Ag Test pour le potentiel hémolytique de produits pharmaceutiques et formulations pour la minimisation du risque
WO2014160490A1 (fr) * 2013-03-13 2014-10-02 Genetech, Inc. Formulations d'anticorps
US20140335109A1 (en) * 2011-12-16 2014-11-13 Oncology Institute Of Southern Switzerland Combination of inotuzumab ozogamicin and torisel for the treatment of cancer
US20150274819A1 (en) * 2014-03-03 2015-10-01 La Jolla Biologics, Inc. Stable aqueous recombinant protein formulations
US11370833B2 (en) 2014-09-15 2022-06-28 Genentech, Inc. Antibody formulations
US11633476B2 (en) 2017-05-02 2023-04-25 Merck Sharp & Dohme Llc Stable formulations of programmed death receptor 1 (PD-1) antibodies and methods of use thereof
US11845798B2 (en) 2017-05-02 2023-12-19 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies

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CZ303450B6 (cs) 2001-04-13 2012-09-19 Biogen Idec Ma Inc. Protilátky k VLA-1, kompozice je obsahující a nukleové kyseliny, které je kódují, zpusob stanovení hladiny VLA-1 a použití pri lécení imunologického onemocnení
BRPI0712607A8 (pt) 2006-05-25 2019-06-04 Biogen Idec Inc métodos de tratamento de acidente vascular cerebral
MX361668B (es) * 2009-12-21 2018-12-11 Genentech Inc Formulación de anticuerpos.
JP2014510152A (ja) * 2011-04-07 2014-04-24 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 粘度が低減された処方物
WO2013040196A2 (fr) 2011-09-14 2013-03-21 Immunovative Therapies, Ltd. Dispositif automatisé de délivrance de médicaments biologiques
CN104271122A (zh) 2012-02-16 2015-01-07 桑塔鲁斯股份有限公司 抗vla1(cd49a)抗体药物组合物
EP2854760B1 (fr) * 2012-05-25 2018-10-17 Novartis AG Composition pharmaceutique aqueuse contenant un agent thérapeutique biologique et de la l-arginine, et injection comprenant la composition
TWI610861B (zh) * 2012-09-13 2018-01-11 梵提夫免疫療法公司 用於生物藥品分配的自動化裝置
CN103385852B (zh) * 2013-08-06 2015-03-11 南京正大天晴制药有限公司 一种盐酸法舒地尔注射液及其制备方法
ES2875878T3 (es) 2013-11-18 2021-11-11 Formycon Ag Composición farmacéutica de un anticuerpo anti-VEGF
CN104906576B (zh) * 2014-03-13 2018-06-19 四川科伦博泰生物医药股份有限公司 可供皮下注射的高浓度抗vegf抗体配制剂
CN104922668B (zh) * 2014-12-10 2019-08-23 信达生物制药(苏州)有限公司 一种稳定的抗vegf抗体制剂及其用途
WO2016120753A1 (fr) * 2015-01-28 2016-08-04 Pfizer Inc. Formulation aqueuse stable d'anticorps anti-facteur de croissance endothélial vasculaire
CN107537036A (zh) * 2016-06-27 2018-01-05 江苏泰康生物医药有限公司 一种抗人血管内皮生长因子单克隆抗体的药物制剂及其应用
WO2018063963A1 (fr) 2016-09-28 2018-04-05 Board Of Regents, The University Of Texas System Formulations thérapeutiques d'anticorps et de protéines et leurs utilisations
CN106918658B (zh) * 2017-01-22 2020-01-31 合肥拓锐生物科技有限公司 一种阿昔替尼原料及其制剂中有关物质的分析方法
EP3624846A1 (fr) 2017-05-16 2020-03-25 Bhami's Research Laboratory, Pvt. Ltd. Formulations de protéines à haute concentration ayant une viscosité réduite
CN112618482A (zh) * 2019-09-24 2021-04-09 江苏恒瑞医药股份有限公司 新型蛋白制剂
AU2020364480A1 (en) * 2019-10-08 2022-03-31 Samsung Bioepis Co., Ltd. Stable liquid composition, method for preparing same, and formulation comprising same
WO2021079337A1 (fr) * 2019-10-23 2021-04-29 Cadila Healthcare Limited Formulation pharmaceutique d'anticorps anti-her2 et sa préparation
EP4182697A1 (fr) * 2020-07-14 2023-05-24 JANSSEN Pharmaceutica NV Dosage sanguin permettant la détection d'une tauopathie ou d'une maladie amyloïdogène
EP4232155A1 (fr) * 2020-10-26 2023-08-30 JANSSEN Pharmaceutica NV Procédés de réduction de la protéine tau chez des sujets humains

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WO2007124299A2 (fr) * 2006-04-21 2007-11-01 Novartis Ag Compositions pharmaceutiques d'anticorps anti-cd40 antagoniste
US8318161B2 (en) * 2009-03-06 2012-11-27 Genentech, Inc. Anti-oxidized LDL antibody formulation

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