TW201827830A - 連續性病毒清除之驗證 - Google Patents

連續性病毒清除之驗證 Download PDF

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Publication number
TW201827830A
TW201827830A TW106135849A TW106135849A TW201827830A TW 201827830 A TW201827830 A TW 201827830A TW 106135849 A TW106135849 A TW 106135849A TW 106135849 A TW106135849 A TW 106135849A TW 201827830 A TW201827830 A TW 201827830A
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TW
Taiwan
Prior art keywords
virus
probe
cfi
sample
continuous
Prior art date
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TW106135849A
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English (en)
Chinese (zh)
Inventor
班傑明 麥瑟
彼得 史旺
勞拉 哈特曼
馬丁 羅貝登
Original Assignee
美商拜耳保健有限責任公司
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Application filed by 美商拜耳保健有限責任公司 filed Critical 美商拜耳保健有限責任公司
Publication of TW201827830A publication Critical patent/TW201827830A/zh

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • C12Q1/701Specific hybridization probes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22Testing for sterility conditions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05Living organisms or biological materials
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005Assays involving biological materials from specific organisms or of a specific nature from viruses

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Virology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
TW106135849A 2016-10-21 2017-10-19 連續性病毒清除之驗證 TW201827830A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
??16194959.9 2016-10-21
EP16194959.9A EP3141611A3 (en) 2016-10-21 2016-10-21 Validation of continuous viral clearance

Publications (1)

Publication Number Publication Date
TW201827830A true TW201827830A (zh) 2018-08-01

Family

ID=57209212

Family Applications (1)

Application Number Title Priority Date Filing Date
TW106135849A TW201827830A (zh) 2016-10-21 2017-10-19 連續性病毒清除之驗證

Country Status (16)

Country Link
US (1) US10894991B2 (https=)
EP (2) EP3141611A3 (https=)
JP (1) JP2019537435A (https=)
KR (1) KR20190066017A (https=)
CN (1) CN110100008A (https=)
AR (1) AR109846A1 (https=)
AU (1) AU2017345412A1 (https=)
BR (1) BR112019007835A2 (https=)
CA (1) CA3041253A1 (https=)
IL (1) IL266095A (https=)
MX (1) MX385466B (https=)
RU (1) RU2755634C2 (https=)
SG (1) SG10202104023QA (https=)
TW (1) TW201827830A (https=)
UY (1) UY37447A (https=)
WO (1) WO2018075716A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3651811A1 (en) * 2017-07-10 2020-05-20 Baxalta Incorporated Method for incubating liquids and inactivating viruses
US20230103302A1 (en) * 2020-02-28 2023-04-06 Asahi Kasei Medical Co., Ltd. Method for evaluating viral clearance capability
CA3195893A1 (en) * 2020-09-21 2022-03-24 Bayer Healthcare Llc Pathogen clearance system and method
US12203914B2 (en) * 2020-11-12 2025-01-21 Sartorius Bioanalytical Instruments, Inc. Viral clearance evaluation for biological medical product preparation processes
JP7612001B2 (ja) * 2021-03-26 2025-01-10 旭化成メディカル株式会社 ウイルスクリアランス試験の方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112012026095A2 (pt) * 2010-04-14 2015-09-15 Emd Millipore Corp métodos de produção de estoques de vírus de alta pureza e altos títulos e métodos de uso dos mesmos.
AU2014100888A4 (en) * 2014-08-07 2014-09-11 Novartis Ag Virus clearance and protein purification methods

Also Published As

Publication number Publication date
RU2019115375A (ru) 2020-11-23
EP3141611A2 (en) 2017-03-15
SG10202104023QA (en) 2021-06-29
EP3141611A3 (en) 2017-05-10
MX2019004540A (es) 2019-06-12
RU2019115375A3 (https=) 2021-03-19
WO2018075716A1 (en) 2018-04-26
AU2017345412A1 (en) 2019-04-18
IL266095A (en) 2019-06-30
CN110100008A (zh) 2019-08-06
JP2019537435A (ja) 2019-12-26
EP3529367A1 (en) 2019-08-28
BR112019007835A2 (pt) 2019-10-01
US10894991B2 (en) 2021-01-19
US20190316213A1 (en) 2019-10-17
MX385466B (es) 2025-03-18
CA3041253A1 (en) 2018-04-26
UY37447A (es) 2018-05-31
KR20190066017A (ko) 2019-06-12
AR109846A1 (es) 2019-01-30
RU2755634C2 (ru) 2021-09-17

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