AU2018236651B2 - Liquid formulation of anti-TNF alpha antibody - Google Patents

Liquid formulation of anti-TNF alpha antibody Download PDF

Info

Publication number: AU2018236651B2
Authority: AU; Australia
Prior art keywords: formulation; adalimumab; arginine; formulations; liquid formulation
Prior art date: 2017-03-16
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.): Active

Application number

AU2018236651A

Other languages

English (en)

Other versions

AU2018236651A1 (en

Inventor

Youn Kyung Ko

Jin Eon So

Sora YUN

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.)

LG Chem Ltd

Original Assignee

LG Chem Ltd

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.)

2017-03-16

Filing date

2018-03-16

Publication date

2020-12-10

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63522490&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018236651(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2018-03-16 Application filed by LG Chem Ltd filed Critical LG Chem Ltd

2019-10-31 Publication of AU2018236651A1 publication Critical patent/AU2018236651A1/en

2020-12-10 Application granted granted Critical

2020-12-10 Publication of AU2018236651B2 publication Critical patent/AU2018236651B2/en

Status Active legal-status Critical Current

2038-03-16 Anticipated expiration legal-status Critical

Classifications

- 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
- 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
- A61K39/39591—Stabilisation, fragmentation
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K40/00—Cellular immunotherapy
- A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
- A61K40/41—Vertebrate antigens
- A61K40/42—Cancer antigens
- A61K40/4231—Cytokines
- A61K40/4232—Tumor necrosis factors [TNF] or CD70
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Medicinal Chemistry (AREA)
Veterinary Medicine (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
Bioinformatics & Cheminformatics (AREA)
Immunology (AREA)
Microbiology (AREA)
Mycology (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Medicinal Preparation (AREA)
Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Biomedical Technology (AREA)
Oncology (AREA)
Endocrinology (AREA)
Peptides Or Proteins (AREA)

AU2018236651A 2017-03-16 2018-03-16 Liquid formulation of anti-TNF alpha antibody Active AU2018236651B2 (en)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
KR10-2017-0033188		2017-03-16
KR20170033188		2017-03-16
PCT/KR2018/003097 WO2018169348A1 (fr)	2017-03-16	2018-03-16	Formulation liquide d'anticorps anti-tnf alpha

Publications (2)

Publication Number	Publication Date
AU2018236651A1 AU2018236651A1 (en)	2019-10-31
AU2018236651B2 true AU2018236651B2 (en)	2020-12-10

Family

ID=63522490

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
AU2018236651A Active AU2018236651B2 (en)	2017-03-16	2018-03-16	Liquid formulation of anti-TNF alpha antibody

Country Status (14)

Country	Link
JP (2)	JP7109849B2 (fr)
KR (2)	KR20180106974A (fr)
CN (1)	CN110621303A (fr)
AU (1)	AU2018236651B2 (fr)
CO (1)	CO2019010860A2 (fr)
MA (1)	MA46988A1 (fr)
MX (1)	MX2019010895A (fr)
MY (1)	MY197202A (fr)
NZ (1)	NZ757965A (fr)
PH (1)	PH12019502075A1 (fr)
RU (1)	RU2756619C2 (fr)
UA (1)	UA123847C2 (fr)
WO (1)	WO2018169348A1 (fr)
ZA (1)	ZA201906696B (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US11634485B2 (en) *	2019-02-18	2023-04-25	Eli Lilly And Company	Therapeutic antibody formulation
AU2020244106A1 (en) *	2019-03-18	2021-09-30	Alvotech Hf	Aqueous formulations of TNF-alpha antibodies in high concentrations
TW202519263A (zh) *	2019-03-21	2025-05-16	美商再生元醫藥公司	含有抗il-33抗體之穩定調配物
EP4108258A4 (fr) *	2020-02-20	2024-03-06	Bio-Thera Solutions, Ltd.	Préparation d'anticorps anti-tnf-alpha, sa méthode de préparation et son utilisation
BR112022026670A2 (pt) *	2020-07-13	2023-01-24	Merck Patent Gmbh	Excipientes de redução da viscosidade e combinações dos mesmos para formulações de proteína altamente concentradas

Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2015151115A1 (fr) *	2014-04-02	2015-10-08	Intas Pharmaceuticals Limited	Composition pharmaceutique liquide d'adalimumab
WO2016066688A1 (fr) *	2014-10-28	2016-05-06	Richter Gedeon Nyrt.	Formulation pharmaceutique d'anticorps anti-tnf-alpha

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US8821865B2 (en) *	2010-11-11	2014-09-02	Abbvie Biotechnology Ltd.	High concentration anti-TNFα antibody liquid formulations
UY34105A (es) *	2011-06-03	2012-07-31	Lg Life Sciences Ltd	Formulación líquida estable de etanercept
EP2822591B1 (fr) *	2012-03-07	2018-05-02	Cadila Healthcare Limited	Formulations pharmaceutiques d'anticorps anti-tnf-alpha
KR102238677B1 (ko)	2012-09-07	2021-04-12	코히러스 바이오사이언시즈, 인코포레이티드	아달리무맙의 안정한 수성 제형
JP2016505633A (ja)	2013-01-24	2016-02-25	グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッドＧｌａｘｏｓｍｉｔｈｋｌｉｎｅＩｎｔｅｌｌｅｃｔｕａｌＰｒｏｐｅｒｔｙＤｅｖｅｌｏｐｍｅｎｔＬｉｍｉｔｅｄ	ＴＮＦα抗原結合性タンパク質
CA2906101A1 (fr)	2013-03-15	2014-09-18	Bayer Healthcare Llc	Formulations d'anticorps anti-recepteurs de prolactine
WO2015134406A1 (fr)	2014-03-03	2015-09-11	La Jolla Biologics, Inc.	Préparations aqueuses stables de protéine recombinée
EP3050557A1 (fr) *	2014-05-23	2016-08-03	Ares Trading S.A.	Composition pharmaceutique liquide
US9821059B2 (en)	2014-10-17	2017-11-21	Alteogen Inc.	Composition for stabilizing protein and pharmaceutical formulation comprising the same
AR103544A1 (es) *	2015-01-28	2017-05-17	Mabxience S A	FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-a
WO2016162819A1 (fr) *	2015-04-07	2016-10-13	Lupin Limited	Composition pharmaceutique aqueuse stable d'anticorps anti-tnf alpha

2018
- 2018-03-16 UA UAA201909838A patent/UA123847C2/uk unknown
- 2018-03-16 AU AU2018236651A patent/AU2018236651B2/en active Active
- 2018-03-16 MA MA46988A patent/MA46988A1/fr unknown
- 2018-03-16 NZ NZ757965A patent/NZ757965A/en unknown
- 2018-03-16 JP JP2019551275A patent/JP7109849B2/ja active Active
- 2018-03-16 MY MYPI2019005331A patent/MY197202A/en unknown
- 2018-03-16 MX MX2019010895A patent/MX2019010895A/es unknown
- 2018-03-16 KR KR1020180031016A patent/KR20180106974A/ko not_active Ceased
- 2018-03-16 CN CN201880031705.6A patent/CN110621303A/zh active Pending
- 2018-03-16 WO PCT/KR2018/003097 patent/WO2018169348A1/fr not_active Ceased
- 2018-03-16 RU RU2019130728A patent/RU2756619C2/ru active
2019
- 2019-09-12 PH PH12019502075A patent/PH12019502075A1/en unknown
- 2019-09-30 CO CONC2019/0010860A patent/CO2019010860A2/es unknown
- 2019-10-10 ZA ZA2019/06696A patent/ZA201906696B/en unknown
2020
- 2020-08-05 KR KR1020200098144A patent/KR102342292B1/ko active Active
2022
- 2022-05-06 JP JP2022076654A patent/JP2022097600A/ja not_active Withdrawn

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2015151115A1 (fr) *	2014-04-02	2015-10-08	Intas Pharmaceuticals Limited	Composition pharmaceutique liquide d'adalimumab
WO2016066688A1 (fr) *	2014-10-28	2016-05-06	Richter Gedeon Nyrt.	Formulation pharmaceutique d'anticorps anti-tnf-alpha

Also Published As

Publication number	Publication date
UA123847C2 (uk)	2021-06-09
CN110621303A (zh)	2019-12-27
RU2756619C2 (ru)	2021-10-04
MA46988A1 (fr)	2020-06-30
PH12019502075A1 (en)	2020-09-14
CO2019010860A2 (es)	2020-01-17
MY197202A (en)	2023-05-31
NZ757965A (en)	2022-07-01
KR20200096472A (ko)	2020-08-12
RU2019130728A3 (fr)	2021-04-16
BR112019019162A2 (pt)	2020-04-14
AU2018236651A1 (en)	2019-10-31
KR102342292B1 (ko)	2021-12-24
MX2019010895A (es)	2019-11-05
WO2018169348A1 (fr)	2018-09-20
JP7109849B2 (ja)	2022-08-01
JP2020510079A (ja)	2020-04-02
KR20180106974A (ko)	2018-10-01
ZA201906696B (en)	2020-08-26
JP2022097600A (ja)	2022-06-30
RU2019130728A (ru)	2021-04-16

Publication	Publication Date	Title
AU2018236651B2 (en)	2020-12-10	Liquid formulation of anti-TNF alpha antibody
AU2007338791B2 (en)	2014-03-13	Stable buffered formulations containing polypeptides
AU2007307107B2 (en)	2011-11-03	Stable antibody formulations
AU2007309616B2 (en)	2011-10-06	Stable polypeptide formulations
CA2976298A1 (fr)	2016-08-18	Formulation liquide stable pour des anticorps monoclonaux
KR20240095255A (ko)	2024-06-25	인간화 항-cd40 항체의 약학적 조성물
EP3247394B1 (fr)	2021-05-12	Formulation pharmaceutique comprenant des anticorps anti-egfr
BR112019019162B1 (pt)	2024-10-22	Formulação líquida de um anticorpo anti-tnf-a e método parapreparar a formulação líquida
AU2014201388B2 (en)	2016-05-12	Stable Buffered Formulations Containing Polypeptides
WO2025255300A1 (fr)	2025-12-11	Formulations pour anticorps anti-n3pglu amyloïde bêta
AU2016213875A1 (en)	2016-09-01	Stable Buffered Formulations Containing Polypeptides
EP3533441A2 (fr)	2019-09-04	Formulation pharmaceutique stable

Legal Events

Date	Code	Title	Description
2021-04-08	FGA	Letters patent sealed or granted (standard patent)