CA3152838A1 - Novel formulation of highly concentrated pharmacologically active antibody - Google Patents
Novel formulation of highly concentrated pharmacologically active antibody Download PDFInfo
- Publication number
- CA3152838A1 CA3152838A1 CA3152838A CA3152838A CA3152838A1 CA 3152838 A1 CA3152838 A1 CA 3152838A1 CA 3152838 A CA3152838 A CA 3152838A CA 3152838 A CA3152838 A CA 3152838A CA 3152838 A1 CA3152838 A1 CA 3152838A1
- Authority
- CA
- Canada
- Prior art keywords
- pharmaceutical
- formulation according
- lysine
- present
- antibody
- 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.)
- Pending
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/42—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins
- C07K16/4283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
- C07K16/4291—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- 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
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201921035059 | 2019-08-30 | ||
| IN201921035059 | 2019-08-30 | ||
| PCT/IB2020/058080 WO2021038532A1 (en) | 2019-08-30 | 2020-08-29 | Novel formulation of highly concentrated pharmacologically active antibody |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA3152838A1 true CA3152838A1 (en) | 2021-03-04 |
Family
ID=74684124
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3152838A Pending CA3152838A1 (en) | 2019-08-30 | 2020-08-29 | Novel formulation of highly concentrated pharmacologically active antibody |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US20220267473A1 (https=) |
| EP (1) | EP4021497B1 (https=) |
| JP (1) | JP7792137B2 (https=) |
| AU (1) | AU2020337093B2 (https=) |
| CA (1) | CA3152838A1 (https=) |
| WO (1) | WO2021038532A1 (https=) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2021262609A1 (en) | 2020-05-01 | 2022-12-22 | Kashiv Biosciences, Llc | An improved process of purification of protein |
| CA3237624A1 (en) * | 2023-07-28 | 2025-04-24 | Genentech, Inc. | NEW USES FOR OMALIZUMAB |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2002213441B2 (en) * | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| MXPA05010555A (es) * | 2003-04-04 | 2006-03-09 | Genentech Inc | Formulaciones de proteina y anticuerpo de alta concentracion. |
| NZ595526A (en) | 2007-06-14 | 2013-03-28 | Biogen Idec Inc | Pharmaceutical composition comprising a vla-4 binding antibody, a phosphate buffer and a surfactant |
| PT3345593T (pt) * | 2009-11-13 | 2023-11-27 | Sanofi Aventis Deutschland | Composição farmacêutica compreendendo despro36exendina- 4(1-39)-lys6-nh2 e metionina |
| AR089434A1 (es) * | 2011-12-23 | 2014-08-20 | Genentech Inc | Procedimiento para preparar formulaciones con alta concentracion de proteinas |
| JP2015509526A (ja) | 2012-03-07 | 2015-03-30 | カディラ ヘルスケア リミティド | 医薬製剤 |
| PE20150964A1 (es) * | 2012-09-07 | 2015-07-25 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
| JP2016515120A (ja) | 2013-03-15 | 2016-05-26 | バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． | 抗アルファｖベータ５抗体を用いた急性腎損傷の治療及び予防 |
| RS57864B1 (sr) * | 2013-06-17 | 2018-12-31 | De Staat Der Nederlanden Vert Door De Minister Van Vws Ministerie Van Volksgezondheid Welzijn En Spo | Postupci za sprečavanje agregacije virusnih komponenti |
| WO2016109822A1 (en) | 2014-12-31 | 2016-07-07 | Novelmed Therapeutics, Inc. | Formulation of aglycosylated therapeutic antibodies |
| SG10202012778YA (en) | 2015-12-18 | 2021-01-28 | Astellas Pharma Inc | Pharmaceutical composition comprising anti-human tslp receptor antibody |
| EP3443346B1 (en) * | 2016-04-13 | 2023-08-30 | Medimmune, LLC | Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents |
| US10646569B2 (en) * | 2017-05-16 | 2020-05-12 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| DK3658184T5 (da) | 2017-07-27 | 2024-08-26 | Alexion Pharma Inc | Højkoncentrerede anti-c5-antistofformuleringer |
-
2020
- 2020-08-29 EP EP20858260.1A patent/EP4021497B1/en active Active
- 2020-08-29 JP JP2022513090A patent/JP7792137B2/ja active Active
- 2020-08-29 WO PCT/IB2020/058080 patent/WO2021038532A1/en not_active Ceased
- 2020-08-29 CA CA3152838A patent/CA3152838A1/en active Pending
- 2020-08-29 AU AU2020337093A patent/AU2020337093B2/en active Active
-
2022
- 2022-02-28 US US17/682,314 patent/US20220267473A1/en active Pending
-
2024
- 2024-10-25 US US18/926,965 patent/US20250043027A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| AU2020337093B2 (en) | 2025-02-27 |
| US20250043027A1 (en) | 2025-02-06 |
| WO2021038532A1 (en) | 2021-03-04 |
| JP7792137B2 (ja) | 2025-12-25 |
| US20220267473A1 (en) | 2022-08-25 |
| EP4021497A1 (en) | 2022-07-06 |
| EP4021497B1 (en) | 2026-02-25 |
| JP2022546400A (ja) | 2022-11-04 |
| AU2020337093A1 (en) | 2022-04-21 |
| EP4021497A4 (en) | 2023-09-06 |
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