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
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- 230000001225 therapeutic effect Effects 0.000 title abstract 5
- 239000000546 pharmaceutical excipient Substances 0.000 title abstract 4
- 102000004169 proteins and genes Human genes 0.000 title abstract 4
- 108090000623 proteins and genes Proteins 0.000 title abstract 4
- 230000000087 stabilizing effect Effects 0.000 title abstract 4
- 239000004480 active ingredient Substances 0.000 abstract 3
- 238000000034 method Methods 0.000 abstract 2
- 230000002411 adverse Effects 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 238000001802 infusion Methods 0.000 abstract 1
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 [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], 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)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (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)
- Gynecology & Obstetrics (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Pregnancy & Childbirth (AREA)
- Endocrinology (AREA)
- Reproductive Health (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 (cg-RX-API-DMAC7.html) |
| EP (1) | EP3484520A4 (cg-RX-API-DMAC7.html) |
| JP (1) | JP2019527729A (cg-RX-API-DMAC7.html) |
| KR (1) | KR20190027878A (cg-RX-API-DMAC7.html) |
| CA (1) | CA3030422C (cg-RX-API-DMAC7.html) |
| WO (1) | WO2018013673A1 (cg-RX-API-DMAC7.html) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019173338A1 (en) * | 2018-03-07 | 2019-09-12 | Reform Biologics, Llc | Excipient compounds for protein formulations |
| US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
| US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
| 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 |
| WO2019180561A1 (en) | 2018-03-20 | 2019-09-26 | Mankind Pharma Ltd. | Stable pharmaceutical composition of vasopressin |
| CN116585466A (zh) | 2018-05-10 | 2023-08-15 | 瑞泽恩制药公司 | 含有高浓度vegf受体融合蛋白的制剂 |
| WO2020061414A1 (en) | 2018-09-20 | 2020-03-26 | Levo Therapeutics, Inc. | Stable intranasal formulations of carbetocin |
| CN112969450B (zh) | 2018-09-20 | 2023-05-30 | 阿卡蒂亚药品公司 | 卡贝缩宫素药物产品及用于制备其的方法 |
| GB201904741D0 (en) * | 2019-04-04 | 2019-05-22 | Glaxosmithkline Ip Dev Ltd | Novel process |
| WO2020213682A1 (ja) * | 2019-04-19 | 2020-10-22 | 富士フイルム和光純薬株式会社 | 細胞外小胞の保存安定化剤及び保存安定化方法 |
| EP4178529A1 (en) * | 2020-07-07 | 2023-05-17 | F. Hoffmann-La Roche AG | Alternative surfactants as stabilizers for therapeutic protein formulations |
| WO2023203257A1 (en) * | 2022-04-22 | 2023-10-26 | Janssen Sciences Ireland Unlimited Company | Freeze dried compositions |
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 |
| AU2002304784A1 (en) * | 2001-03-26 | 2002-10-08 | Novartis Pharma Gmbh | Pharmaceutical composition comprising a poorly water-soluble active ingredient, a surfactant and a water-soluble 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 |
| JP5081976B2 (ja) | 2007-10-22 | 2012-11-28 | ベクトン・ディキンソン・アンド・カンパニー | オルガノポリシロキサンを含む懸濁液においてタンパク質の凝集を評価するための方法 |
| CN101795680A (zh) | 2007-11-16 | 2010-08-04 | 波苏蛋白试剂公司 | 稳定蛋白质的辅剂 |
| KR20120089843A (ko) * | 2009-07-31 | 2012-08-14 | 사노피-아벤티스 도이칠란트 게엠베하 | 인슐린 링커 접합체를 포함한 프로드럭 |
| MX344732B (es) * | 2010-04-27 | 2017-01-04 | Scil Tech Gmbh | Formulacion estable de 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 |
| KR102058307B1 (ko) | 2010-06-24 | 2019-12-20 | 제넨테크, 인크. | 단백질-함유 제제를 안정화시키기 위한 알킬글리코시드 함유 조성물 및 방법 |
| SG10201701634PA (en) * | 2011-03-25 | 2017-04-27 | Amgen Inc | Anti - sclerostin antibody crystals and formulations thereof |
| EP2855502B1 (en) | 2012-05-31 | 2019-06-26 | Agency For Science, Technology And Research | Methods for reducing levels of protein-contaminant complexes and aggregates in protein preparations by treatment with electropositive organic additives |
| JP2015526471A (ja) * | 2012-08-21 | 2015-09-10 | ジェネシス リサーチ インスティチュート | アントラサイクリン誘発性心毒性を治療または予防するための組成物および方法 |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| EP2926834A4 (en) | 2012-11-27 | 2016-04-20 | Alteogen Inc | COMPOSITION FOR STABILIZING A FUSION PROTEIN IN WHICH A PROTEIN AND A DOMAIN FC ARE MERGED |
| WO2014151705A1 (en) | 2013-03-15 | 2014-09-25 | Ansun Biopharma, Inc. | Methods for preparing injectable protein microparticle suspensions |
| WO2014173886A1 (en) * | 2013-04-22 | 2014-10-30 | Glycotope Gmbh | Anti-cancer treatments with anti-egfr antibodies having a low fucosylation |
| 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 EP EP17828373.5A patent/EP3484520A4/en not_active Withdrawn
- 2017-07-12 WO PCT/US2017/041691 patent/WO2018013673A1/en not_active Ceased
- 2017-07-12 JP JP2019522614A patent/JP2019527729A/ja active Pending
- 2017-07-12 KR KR1020197003892A patent/KR20190027878A/ko not_active Ceased
- 2017-07-12 US US15/647,669 patent/US10279048B2/en active Active
- 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 |
|---|---|
| CA3030422A1 (en) | 2018-01-18 |
| JP2019527729A (ja) | 2019-10-03 |
| US10610600B2 (en) | 2020-04-07 |
| US10279048B2 (en) | 2019-05-07 |
| US20180015169A1 (en) | 2018-01-18 |
| EP3484520A4 (en) | 2020-07-29 |
| US10016513B2 (en) | 2018-07-10 |
| US20190275159A1 (en) | 2019-09-12 |
| US20180015168A1 (en) | 2018-01-18 |
| US20200282065A1 (en) | 2020-09-10 |
| EP3484520A1 (en) | 2019-05-22 |
| WO2018013673A1 (en) | 2018-01-18 |
| KR20190027878A (ko) | 2019-03-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20190109 |