JP6465800B2 - エンベロープウイルスを不活化するための方法および組成物 - Google Patents

エンベロープウイルスを不活化するための方法および組成物 Download PDF

Info

Publication number
JP6465800B2
JP6465800B2 JP2015526635A JP2015526635A JP6465800B2 JP 6465800 B2 JP6465800 B2 JP 6465800B2 JP 2015526635 A JP2015526635 A JP 2015526635A JP 2015526635 A JP2015526635 A JP 2015526635A JP 6465800 B2 JP6465800 B2 JP 6465800B2
Authority
JP
Japan
Prior art keywords
recombinant protein
surfactant
concentration
sulfobetaine
zwitterionic surfactant
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
JP2015526635A
Other languages
English (en)
Japanese (ja)
Other versions
JP2015525572A5 (enExample
JP2015525572A (ja
Inventor
コンリー,リン,エドワード
タオ,インイン
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.)
Biogen MA Inc
Original Assignee
Biogen MA Inc
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
Application filed by Biogen MA Inc filed Critical Biogen MA Inc
Publication of JP2015525572A publication Critical patent/JP2015525572A/ja
Publication of JP2015525572A5 publication Critical patent/JP2015525572A5/ja
Application granted granted Critical
Publication of JP6465800B2 publication Critical patent/JP6465800B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/16011Herpesviridae
    • C12N2710/16711Varicellovirus, e.g. human herpesvirus 3, Varicella Zoster, pseudorabies
    • C12N2710/16761Methods of inactivation or attenuation
    • C12N2710/16763Methods of inactivation or attenuation by chemical treatment
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/13011Gammaretrovirus, e.g. murine leukeamia virus
    • C12N2740/13061Methods of inactivation or attenuation
    • C12N2740/13063Methods of inactivation or attenuation by chemical treatment

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Wood Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2015526635A 2012-08-06 2013-08-06 エンベロープウイルスを不活化するための方法および組成物 Active JP6465800B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261680039P 2012-08-06 2012-08-06
US61/680,039 2012-08-06
PCT/US2013/053781 WO2014025771A2 (en) 2012-08-06 2013-08-06 Methods and compositions for inactivating enveloped viruses

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2018190622A Division JP6833788B2 (ja) 2012-08-06 2018-10-09 エンベロープウイルスを不活化するための方法および組成物

Publications (3)

Publication Number Publication Date
JP2015525572A JP2015525572A (ja) 2015-09-07
JP2015525572A5 JP2015525572A5 (enExample) 2016-09-29
JP6465800B2 true JP6465800B2 (ja) 2019-02-06

Family

ID=48986268

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2015526635A Active JP6465800B2 (ja) 2012-08-06 2013-08-06 エンベロープウイルスを不活化するための方法および組成物
JP2018190622A Active JP6833788B2 (ja) 2012-08-06 2018-10-09 エンベロープウイルスを不活化するための方法および組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2018190622A Active JP6833788B2 (ja) 2012-08-06 2018-10-09 エンベロープウイルスを不活化するための方法および組成物

Country Status (5)

Country Link
US (2) US10188732B2 (enExample)
EP (2) EP2879691B1 (enExample)
JP (2) JP6465800B2 (enExample)
DK (1) DK2879691T3 (enExample)
WO (1) WO2014025771A2 (enExample)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2879691B1 (en) 2012-08-06 2019-03-27 Biogen MA Inc. Methods for inactivating enveloped viruses
CA2961510A1 (en) 2014-09-17 2016-03-24 Helixbind, Inc. Methods and devices for detecting and identifying microorganisms
TW201628649A (zh) 2014-10-09 2016-08-16 再生元醫藥公司 減少醫藥調配物中微可見顆粒之方法
EP3420341B1 (en) * 2016-02-24 2020-11-18 Bio-Rad Laboratories, Inc. Methods and compositions for fluorescence detection
US11020686B2 (en) 2016-08-16 2021-06-01 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
BR112019006689A2 (pt) 2016-10-25 2019-06-25 Regeneron Pharma métodos e sistemas para análise de dados de cromatografia
EP3446710A1 (en) * 2017-08-25 2019-02-27 Glenmark Pharmaceuticals S.A. Methods of inactivating viral contaminants
KR102790861B1 (ko) 2017-09-18 2025-04-08 바이엘 헬쓰케어 엘엘씨 N-메틸글루카미드 및 그의 유도체를 사용한 바이러스 불활성화 방법
US12042538B2 (en) 2017-09-19 2024-07-23 Regeneron Pharmaceuticals, Inc. Methods of reducing particle formation and compositions formed thereby
SG11202003793WA (en) 2017-10-30 2020-05-28 Baxalta GmbH Environmentally compatible detergents for inactivation of lipid-enveloped viruses
TWI853823B (zh) 2018-07-02 2024-09-01 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
MX2021005685A (es) 2018-11-15 2021-07-07 Bayer Healthcare Llc Metodos de inactivacion virica para la fabricacion continua de anticuerpos.
WO2020190985A1 (en) * 2019-03-19 2020-09-24 Amgen Inc. Alternate detergents for viral inactivation
CN110424030B (zh) * 2019-08-30 2020-06-30 广州三孚新材料科技股份有限公司 无氰碱性电镀铜液及其制备和在挠性印刷线路板中的应用
US20230183656A1 (en) * 2020-05-14 2023-06-15 Merck Patent Gmbh Methods and compositions for purifying adeno associated virus particles or adenoviruses
US11643641B2 (en) 2021-03-04 2023-05-09 Malireddy S. Reddy Prevention of viral transmission by naked genetic material
CN117836010A (zh) 2021-06-21 2024-04-05 优尼科生物制药有限公司 改进的裂解程序
EP4626230A1 (en) 2022-11-29 2025-10-08 Merck Patent GmbH Method for inactivating enveloped viruses

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE242716C (enExample)
DD242716A3 (de) 1981-08-28 1987-02-11 Adw Der Ddr Inst F Chem Techno Verfahren zur herstellung von gereinigten antigenen bzw. biopraeparaten
DE3704550A1 (de) * 1987-02-13 1988-08-25 Behringwerke Ag Verfahren zur inaktivierung huellhaltiger viren in mittels einer zelle in vitro hergestellten protein-praeparationen
GB8927546D0 (en) 1989-12-06 1990-02-07 Ciba Geigy Process for the production of biologically active tgf-beta
US5314917A (en) 1991-03-22 1994-05-24 E. B. Michaels Research Associates, Inc. Method for inactivating enveloped viruses and sperm
FR2805163A1 (fr) 2000-02-21 2001-08-24 Pf Medicament Utilisation d'un detergent de type zwittergent pour la preparation d'une composition pharmaceutique destinee a etre administree par voie nasale
US6635679B2 (en) * 2001-05-14 2003-10-21 Akzo Nobel N.V. Methods and compositions for inactivating viruses
JP2007517057A (ja) 2003-12-30 2007-06-28 ワイス 改善された耐容性を有する免疫原性組成物中の疎水性タンパク質の処方物
NZ568211A (en) * 2005-11-04 2011-11-25 Novartis Vaccines & Diagnostic Influenza vaccines including combinations of particulate adjuvants and immunopotentiators
EP1970440A1 (en) 2007-03-06 2008-09-17 Qiagen GmbH Polymerase stabilization by ionic detergents
BR112013015113B1 (pt) * 2010-12-15 2023-01-31 Takeda Pharmaceutical Company Limited Método de inativar um vírus contendo envelope lipídico
GB201216121D0 (en) * 2012-09-10 2012-10-24 Novartis Ag Sample quantification by disc centrifugation
EP2879691B1 (en) 2012-08-06 2019-03-27 Biogen MA Inc. Methods for inactivating enveloped viruses

Also Published As

Publication number Publication date
EP2879691A2 (en) 2015-06-10
WO2014025771A2 (en) 2014-02-13
US10702603B2 (en) 2020-07-07
US10188732B2 (en) 2019-01-29
EP2879691B1 (en) 2019-03-27
JP2015525572A (ja) 2015-09-07
US20190175738A1 (en) 2019-06-13
JP6833788B2 (ja) 2021-02-24
US20150306223A1 (en) 2015-10-29
WO2014025771A3 (en) 2014-04-17
DK2879691T3 (da) 2019-06-11
EP3456352A1 (en) 2019-03-20
JP2019037234A (ja) 2019-03-14

Similar Documents

Publication Publication Date Title
JP6465800B2 (ja) エンベロープウイルスを不活化するための方法および組成物
ES2367833T3 (es) Procedimiento para la preparación de un componente activo de un fármaco o agente de diagnóstico en cultivo en suspensión de células mdck.
CN112626124B (zh) 一种病毒保存试剂
RU2012118386A (ru) Стабилизирующий эксципиент для вакцины с инактивированными целыми вирусами
US11167032B2 (en) Methods and compositions for therapeutic agents
Davies Translation of plant virus ribonucleic acids in extracts from eukaryotic cells
JPH0157954B2 (enExample)
US20080193478A1 (en) Inactivated Poliomyelitis Vaccine Derived From Sabin Strain Of Polio Virus
EP1862537A1 (en) Cell line culturable without aminal-derived component, method for establishment thereof, method for production of virus using the cell line and method for production of vaccine
WO2020226831A1 (en) Inactivated virus compositions and zika vaccine formulations
JPH06234659A (ja) 安定化生ワクチン
JP2010268799A (ja) プロナーゼからのトリプシンの単離および精製の方法ならびにそれらの使用
CN105561317A (zh) 重组伪狂犬病病毒疫苗耐热冻干保护剂及其制备方法
US20110097785A1 (en) Method of replicating viruses in suspension cultures of dog kidney cells
JPWO2001076624A1 (ja) 日本脳炎不活化ワクチン及びその製造方法
KR102544928B1 (ko) 아미노산을 유효성분으로 함유하는 동물용 백신 또는 진단용 항원의 안정성 증진용 조성물 및 이의 용도
Alasino et al. Characterization of the inhibition of enveloped virus infectivity by the cationic acrylate polymer eudragit E100
CA2650676A1 (en) Feline cell capable of being cultured without animal-derived protein, and method for producing virus and method for producing vaccine using thereof
CN101570566B (zh) Vero细胞裂解蛋白、制备方法及其用途
KR102180778B1 (ko) 구제역 백신 제조용 종자 바이러스의 보관 방법 및 이를 위한 보존제
US20100040580A1 (en) Freeze-dried composition of inactivated virus envelope with membrane fusion activity
CN112195149B (zh) 一种制备人用狂犬病疫苗的方法
CN117286113A (zh) 重组胰蛋白酶在无动物源成分细胞培养体系的流感疫苗生产的应用
WO2008135230A1 (en) Two-step temperature profile for the propagation of viruses
CN117517284A (zh) 口蹄疫灭活疫苗热稳定剂及其筛选方法

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160808

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20160808

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20170621

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170626

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20170926

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20171124

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20171226

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20180607

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20181009

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20181010

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20181113

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20181210

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20190108

R150 Certificate of patent or registration of utility model

Ref document number: 6465800

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250