CA2945537C - Process for manufacturing glatiramer acetate product - Google Patents

Process for manufacturing glatiramer acetate product Download PDF

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Publication number
CA2945537C
CA2945537C CA2945537A CA2945537A CA2945537C CA 2945537 C CA2945537 C CA 2945537C CA 2945537 A CA2945537 A CA 2945537A CA 2945537 A CA2945537 A CA 2945537A CA 2945537 C CA2945537 C CA 2945537C
Authority
CA
Canada
Prior art keywords
temperature
filter
aqueous pharmaceutical
pharmaceutical solution
solution
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
Application number
CA2945537A
Other languages
English (en)
French (fr)
Other versions
CA2945537A1 (en
Inventor
Rakefet Cohen
Sasson Habbah
Muhammad Safadi
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.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries 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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54199060&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2945537(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Priority to CA2965890A priority Critical patent/CA2965890A1/en
Publication of CA2945537A1 publication Critical patent/CA2945537A1/en
Application granted granted Critical
Publication of CA2945537C publication Critical patent/CA2945537C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; 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
    • A61K9/14—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Psychology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA2945537A 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product Active CA2945537C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2965890A CA2965890A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14/608,126 2015-01-28
US14/608,126 US9155775B1 (en) 2015-01-28 2015-01-28 Process for manufacturing glatiramer acetate product
PCT/US2015/051203 WO2016122722A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2965890A Division CA2965890A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Publications (2)

Publication Number Publication Date
CA2945537A1 CA2945537A1 (en) 2016-08-04
CA2945537C true CA2945537C (en) 2017-08-22

Family

ID=54199060

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2945537A Active CA2945537C (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
CA2965890A Abandoned CA2965890A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2965890A Abandoned CA2965890A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Country Status (30)

Country Link
US (6) US9155775B1 (https=)
EP (3) EP3113785A4 (https=)
JP (2) JP2018503627A (https=)
KR (2) KR101737295B1 (https=)
CN (1) CN107530394B (https=)
AR (1) AR102096A1 (https=)
AU (4) AU2015380381B2 (https=)
BR (1) BR112016023736A2 (https=)
CA (2) CA2945537C (https=)
CL (1) CL2016002607A1 (https=)
CY (1) CY1118826T1 (https=)
DK (1) DK3050556T3 (https=)
EA (3) EA028484B1 (https=)
ES (1) ES2584190T3 (https=)
HR (1) HRP20170625T1 (https=)
HU (1) HUE034059T2 (https=)
IL (3) IL247851A0 (https=)
LT (1) LT3050556T (https=)
ME (1) ME02721B (https=)
MX (1) MX352734B (https=)
PE (1) PE20170296A1 (https=)
PL (1) PL3050556T3 (https=)
PT (1) PT3050556T (https=)
RS (1) RS55959B1 (https=)
RU (1) RU2669769C2 (https=)
SI (1) SI3050556T1 (https=)
SM (1) SMT201700227T1 (https=)
UA (1) UA116060C2 (https=)
WO (1) WO2016122722A1 (https=)
ZA (1) ZA201606903B (https=)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE49251E1 (en) 2010-01-04 2022-10-18 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
CA2814500A1 (en) 2010-10-11 2012-04-19 Teva Pharmaceutical Industries Ltd Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate
HK1200274A1 (en) 2011-10-10 2015-08-07 Teva Pharmaceutical Industries Ltd. Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate
HK1213830A1 (zh) 2012-10-10 2016-07-15 Teva Pharmaceutical Industries Ltd. 用於预测醋酸格拉替雷临床反应的生物标志物
UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
US9155775B1 (en) 2015-01-28 2015-10-13 Teva Pharmaceutical Industries, Ltd. Process for manufacturing glatiramer acetate product
CN107550853B (zh) * 2016-06-30 2020-06-12 深圳翰宇药业股份有限公司 一种醋酸格拉替雷注射液的制备方法
US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
CN109982712A (zh) 2016-08-31 2019-07-05 Mapi医药公司 包含醋酸格拉替雷的储库系统
WO2018106945A1 (en) 2016-12-07 2018-06-14 Progenity Inc. Gastrointestinal tract detection methods, devices and systems
CN110382052A (zh) 2017-03-26 2019-10-25 Mapi医药公司 用于治疗进展型形式的多发性硬化症的格拉替雷储库系统
WO2019005072A1 (en) 2017-06-29 2019-01-03 Regeneron Pharmaceuticals Inc. Devices and methods for overfilling drug containers
US20200306516A1 (en) 2017-08-14 2020-10-01 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with glatiramer or a pharmaceutically acceptable salt thereof
CN112933210A (zh) * 2019-12-11 2021-06-11 深圳翰宇药业股份有限公司 一种西曲瑞克冻干药物组合物的制备方法

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UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
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Also Published As

Publication number Publication date
AU2018200518A1 (en) 2018-02-15
AU2016101453B4 (en) 2016-11-03
SI3050556T1 (sl) 2017-06-30
AU2015380381A1 (en) 2016-09-01
EA028811B1 (ru) 2018-01-31
WO2016122722A1 (en) 2016-08-04
CY1118826T1 (el) 2018-01-10
EP3113785A4 (en) 2017-05-10
ME02721B (me) 2017-10-20
HK1225309B (en) 2017-09-08
US9155775B1 (en) 2015-10-13
LT3050556T (lt) 2017-05-10
ES2584190T3 (es) 2017-07-20
EA028484B1 (ru) 2017-11-30
EA201691790A1 (ru) 2017-01-30
EP3050556B1 (en) 2017-03-22
CL2016002607A1 (es) 2017-05-26
US20170312331A1 (en) 2017-11-02
MX352734B (es) 2017-12-06
US20160213734A1 (en) 2016-07-28
PL3050556T3 (pl) 2017-08-31
IL277601A (en) 2020-11-30
JP2018184433A (ja) 2018-11-22
BR112016023736A2 (pt) 2017-10-10
US20180036363A1 (en) 2018-02-08
KR20170101891A (ko) 2017-09-06
IL247851A0 (en) 2016-11-30
JP6592150B2 (ja) 2019-10-16
EP3238706A1 (en) 2017-11-01
AU2015380381B2 (en) 2016-10-20
AR102096A1 (es) 2017-02-01
RU2669769C2 (ru) 2018-10-16
PT3050556T (pt) 2017-05-17
IL277601B (en) 2021-09-30
UA116060C2 (uk) 2018-01-25
KR101737295B1 (ko) 2017-05-29
PE20170296A1 (es) 2017-04-14
US20180000884A1 (en) 2018-01-04
US20170196930A1 (en) 2017-07-13
CA2945537A1 (en) 2016-08-04
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US9763993B2 (en) 2017-09-19
CN107530394B (zh) 2021-05-25
EA201791555A3 (ru) 2018-05-31
HUE034059T2 (en) 2018-01-29
AU2016273881A1 (en) 2017-01-05
CN107530394A (zh) 2018-01-02
KR20160136348A (ko) 2016-11-29
RS55959B1 (sr) 2017-09-29
EA201791555A2 (ru) 2017-12-29
CA2965890A1 (en) 2016-08-04
EA201500881A1 (ru) 2016-07-29
DK3050556T3 (en) 2017-04-24
KR102268210B1 (ko) 2021-06-23
IL267152A (en) 2019-08-29
JP2018503627A (ja) 2018-02-08
HRP20170625T1 (hr) 2017-06-30
ZA201606903B (en) 2019-02-27
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EP3050556A1 (en) 2016-08-03

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