CA3030422C - Stabilizing excipients for therapeutic protein formulations - Google Patents
Stabilizing excipients for therapeutic protein formulations Download PDFInfo
- Publication number
- CA3030422C CA3030422C CA3030422A CA3030422A CA3030422C CA 3030422 C CA3030422 C CA 3030422C CA 3030422 A CA3030422 A CA 3030422A CA 3030422 A CA3030422 A CA 3030422A CA 3030422 C CA3030422 C CA 3030422C
- Authority
- CA
- Canada
- Prior art keywords
- therapeutic protein
- protein formulations
- active ingredient
- stabilizing excipients
- protein active
- 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.)
- Active
Links
Classifications
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
- A61K47/543—Lipids, e.g. triglycerides; Polyamines, e.g. spermine or spermidine
-
- 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
- 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
- A61K38/00—Medicinal preparations containing peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/04—Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G73/00—Macromolecular compounds obtained by reactions forming a linkage containing nitrogen with or without oxygen or carbon in the main chain of the macromolecule, not provided for in groups C08G12/00 - C08G71/00
- C08G73/02—Polyamines
- C08G73/0233—Polyamines derived from (poly)oxazolines, (poly)oxazines or having pendant acyl groups
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Polymers & Plastics (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Diabetes (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Pregnancy & Childbirth (AREA)
- Gynecology & Obstetrics (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662361793P | 2016-07-13 | 2016-07-13 | |
| US62/361,793 | 2016-07-13 | ||
| PCT/US2017/041691 WO2018013673A1 (en) | 2016-07-13 | 2017-07-12 | Stabilizing excipients for therapeutic protein formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA3030422A1 CA3030422A1 (en) | 2018-01-18 |
| CA3030422C true CA3030422C (en) | 2021-10-26 |
Family
ID=60941865
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3030422A Active CA3030422C (en) | 2016-07-13 | 2017-07-12 | Stabilizing excipients for therapeutic protein formulations |
Country Status (6)
| Country | Link |
|---|---|
| US (4) | US10279048B2 (OSRAM) |
| EP (1) | EP3484520A4 (OSRAM) |
| JP (1) | JP2019527729A (OSRAM) |
| KR (1) | KR20190027878A (OSRAM) |
| CA (1) | CA3030422C (OSRAM) |
| WO (1) | WO2018013673A1 (OSRAM) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
| US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
| US20160074515A1 (en) | 2014-06-20 | 2016-03-17 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
| WO2019036619A1 (en) * | 2017-08-18 | 2019-02-21 | Reform Biologics, Llc | STABILIZING EXCIPIENTS FOR FORMULATIONS OF THERAPEUTIC PROTEIN |
| EP3761962A4 (en) * | 2018-03-07 | 2021-12-15 | ReForm Biologics, Inc. | EXCIPIENT COMPOUNDS FOR PROTEIN-BASED FORMULATIONS |
| US11318183B2 (en) | 2018-03-20 | 2022-05-03 | Mankind Pharma Ltd. | Stable pharmaceutical composition of vasopressin |
| JP7235770B2 (ja) | 2018-05-10 | 2023-03-08 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 高濃度ｖｅｇｆ受容体融合タンパク質を含む製剤 |
| WO2020061416A1 (en) | 2018-09-20 | 2020-03-26 | Levo Therapeutics, Inc. | Carbetocin drug product and process for preparing same |
| US20200093884A1 (en) | 2018-09-20 | 2020-03-26 | Mark C. Manning | Stable intranasal formulations of carbetocin |
| GB201904741D0 (en) * | 2019-04-04 | 2019-05-22 | Glaxosmithkline Ip Dev Ltd | Novel process |
| KR102771126B1 (ko) | 2019-04-19 | 2025-02-20 | 후지필름 가부시키가이샤 | 세포 외 소포의 보존 안정화제 및 보존 안정화 방법 |
| JP2023532764A (ja) * | 2020-07-07 | 2023-07-31 | エフ． ホフマン－ラ ロシュ アーゲー | 治療用タンパク質製剤の安定剤としての代替界面活性剤 |
| CN119403545A (zh) * | 2022-04-22 | 2025-02-07 | 爱尔兰詹森科学公司 | 冷冻干燥的组合物 |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2510633C3 (de) | 1975-03-12 | 1978-07-13 | Boehringer Mannheim Gmbh, 6800 Mannheim | Diagnostisches Mittel zum Nachweis von Eiweiß in Körperflüssigkeiten und dafür geeignete Indikatorfarbstoffe |
| US5183746A (en) * | 1986-10-27 | 1993-02-02 | Schering Aktiengesellschaft | Formulation processes for pharmaceutical compositions of recombinant β- |
| US6039977A (en) * | 1997-12-09 | 2000-03-21 | Alza Corporation | Pharmaceutical hydrogel formulations, and associated drug delivery devices and methods |
| DE60211494T2 (de) * | 2001-03-26 | 2006-10-12 | Novartis Ag | Pharmazeutische zusammensetzung enthaltend ein schlecht wasserlösliches staurosporin, eine oberflächenaktive substanz und ein wasserlösliches polymer |
| US7041088B2 (en) | 2002-10-11 | 2006-05-09 | Ethicon, Inc. | Medical devices having durable and lubricious polymeric coating |
| DE10325198B4 (de) | 2003-06-04 | 2007-10-25 | Clariant Produkte (Deutschland) Gmbh | Verwendung von alkoxylierten vernetzten Polyglycerinen als biologisch abbaubare Emulsionsspalter |
| US8025915B2 (en) | 2006-01-11 | 2011-09-27 | Schott Ag | Method of preparing a macromolecule deterrent surface on a pharmaceutical package |
| ES2543735T3 (es) | 2007-10-22 | 2015-08-21 | Becton Dickinson And Company | Artículos médicos revestidos con organopolisiloxano que contienen una disolución de proteína y un tensioactivo no iónico |
| WO2009065126A2 (en) * | 2007-11-16 | 2009-05-22 | Boston Protein Solutions | Excipients for protein stabilization |
| SG178193A1 (en) * | 2009-07-31 | 2012-03-29 | Sanofi Aventis Deutschland | Prodrugs comprising an insulin linker conjugate |
| RU2588658C2 (ru) * | 2010-04-27 | 2016-07-10 | ЭсСиАйЭл Текнолоджи ГмбХ | Стабильные водные композиции белка mia/cd-rap |
| US8802603B2 (en) | 2010-06-17 | 2014-08-12 | Becton, Dickinson And Company | Medical components having coated surfaces exhibiting low friction and low reactivity |
| MY184736A (en) | 2010-06-24 | 2021-04-20 | Genentech Inc | Compositions and methods containing alkylglycosides for stabilizing protein-containing formulations |
| EP2688910B1 (en) * | 2011-03-25 | 2019-05-29 | Amgen Inc. | Anti-sclerostin antibody crystals and formulations thereof |
| JP2015519361A (ja) | 2012-05-31 | 2015-07-09 | エイジェンシー・フォー・サイエンス，テクノロジー・アンド・リサーチ | 正電荷有機添加剤での処理によるタンパク質製剤におけるタンパク質−不純物複合体及び凝集体のレベルを低下させるための方法 |
| CA2881818A1 (en) * | 2012-08-21 | 2014-02-27 | Genesys Research Institute | Compositions and methods for treating or preventing anthracycline induced cardiotoxicity |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US9474803B2 (en) | 2012-11-27 | 2016-10-25 | Alteogen Inc. | Composition for stabilizing fusion protein in which protein and FC domain are fused |
| WO2014151705A1 (en) | 2013-03-15 | 2014-09-25 | Ansun Biopharma, Inc. | Methods for preparing injectable protein microparticle suspensions |
| KR20150144804A (ko) * | 2013-04-22 | 2015-12-28 | 글리코토페 게엠베하 | 낮은 푸코실화를 갖는 항ｅｇｆｒ 항체를 이용한 항암 치료 |
| US20160074515A1 (en) | 2014-06-20 | 2016-03-17 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
-
2017
- 2017-07-12 CA CA3030422A patent/CA3030422C/en active Active
- 2017-07-12 US US15/647,669 patent/US10279048B2/en active Active
- 2017-07-12 WO PCT/US2017/041691 patent/WO2018013673A1/en not_active Ceased
- 2017-07-12 EP EP17828373.5A patent/EP3484520A4/en not_active Withdrawn
- 2017-07-12 KR KR1020197003892A patent/KR20190027878A/ko not_active Ceased
- 2017-07-12 JP JP2019522614A patent/JP2019527729A/ja active Pending
- 2017-08-14 US US15/676,168 patent/US10016513B2/en active Active
-
2019
- 2019-03-15 US US16/354,557 patent/US10610600B2/en active Active
-
2020
- 2020-02-13 US US16/789,628 patent/US20200282065A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| JP2019527729A (ja) | 2019-10-03 |
| US20190275159A1 (en) | 2019-09-12 |
| US10279048B2 (en) | 2019-05-07 |
| US10610600B2 (en) | 2020-04-07 |
| US20180015169A1 (en) | 2018-01-18 |
| WO2018013673A1 (en) | 2018-01-18 |
| US20180015168A1 (en) | 2018-01-18 |
| US20200282065A1 (en) | 2020-09-10 |
| CA3030422A1 (en) | 2018-01-18 |
| EP3484520A1 (en) | 2019-05-22 |
| US10016513B2 (en) | 2018-07-10 |
| EP3484520A4 (en) | 2020-07-29 |
| KR20190027878A (ko) | 2019-03-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20190109 |
|
| H13 | Ip right lapsed |
Free format text: ST27 STATUS EVENT CODE: N-6-6-H10-H13-H100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE AND LATE FEE NOT PAID BY DEADLINE OF NOTICE Effective date: 20260407 Free format text: ST27 STATUS EVENT CODE: N-4-6-H10-H13-H100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE AND LATE FEE NOT PAID BY DEADLINE OF NOTICE Effective date: 20260407 |