JP2019537435A - 連続式ウイルスクリアランスのバリデーション - Google Patents

連続式ウイルスクリアランスのバリデーション Download PDF

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Publication number
JP2019537435A
JP2019537435A JP2019520956A JP2019520956A JP2019537435A JP 2019537435 A JP2019537435 A JP 2019537435A JP 2019520956 A JP2019520956 A JP 2019520956A JP 2019520956 A JP2019520956 A JP 2019520956A JP 2019537435 A JP2019537435 A JP 2019537435A
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JP
Japan
Prior art keywords
virus
sampling
probe
cfi
continuous
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.)
Ceased
Application number
JP2019520956A
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English (en)
Japanese (ja)
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JP2019537435A5 (enExample
Inventor
ベンヤミン、マイザー
ペーター、シュバン
ラウラ、ダービト
マルティン、ロベダン
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.)
Bayer AG
Original Assignee
Bayer AG
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 Bayer AG filed Critical Bayer AG
Publication of JP2019537435A publication Critical patent/JP2019537435A/ja
Publication of JP2019537435A5 publication Critical patent/JP2019537435A5/ja
Ceased legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • C12Q1/701—Specific hybridization probes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22—Testing for sterility conditions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029—Radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays 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)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Investigating Or Analysing Biological Materials (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2019520956A 2016-10-21 2017-10-19 連続式ウイルスクリアランスのバリデーション Ceased JP2019537435A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16194959.9A EP3141611A3 (en) 2016-10-21 2016-10-21 Validation of continuous viral clearance
EP16194959.9 2016-10-21
PCT/US2017/057298 WO2018075716A1 (en) 2016-10-21 2017-10-19 Validation of continuous viral clearance

Publications (2)

Publication Number Publication Date
JP2019537435A true JP2019537435A (ja) 2019-12-26
JP2019537435A5 JP2019537435A5 (enExample) 2020-06-18

Family

ID=57209212

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2019520956A Ceased JP2019537435A (ja) 2016-10-21 2017-10-19 連続式ウイルスクリアランスのバリデーション

Country Status (16)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021172573A1 (ja) * 2020-02-28 2021-09-02 旭化成メディカル株式会社 ウイルスクリアランス性能の評価方法

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190022654A1 (en) * 2017-07-10 2019-01-24 Baxalta Incorporated Method for incubating liquids
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
EP4317460A4 (en) * 2021-03-26 2024-10-23 Asahi Kasei Medical Co., Ltd. Viral clearance test method

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

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CHEM. ENG. PROCESS., vol. 102, JPN6020046571, 2016, pages 88 - 101, ISSN: 0004399171 *
KOR. J. MICROBIOL. BIOTECHNOL., vol. 37, no. 4, JPN7020003904, 2009, pages 377 - 382, ISSN: 0004536896 *
PHARM. BIOPROCESS., vol. 2, no. 1, JPN7021002346, 2014, pages 75 - 83, ISSN: 0004536898 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021172573A1 (ja) * 2020-02-28 2021-09-02 旭化成メディカル株式会社 ウイルスクリアランス性能の評価方法

Also Published As

Publication number Publication date
IL266095A (en) 2019-06-30
CA3041253A1 (en) 2018-04-26
EP3529367A1 (en) 2019-08-28
UY37447A (es) 2018-05-31
KR20190066017A (ko) 2019-06-12
CN110100008A (zh) 2019-08-06
MX385466B (es) 2025-03-18
SG10202104023QA (en) 2021-06-29
US20190316213A1 (en) 2019-10-17
RU2019115375A (ru) 2020-11-23
AR109846A1 (es) 2019-01-30
EP3141611A3 (en) 2017-05-10
RU2755634C2 (ru) 2021-09-17
WO2018075716A1 (en) 2018-04-26
MX2019004540A (es) 2019-06-12
EP3141611A2 (en) 2017-03-15
RU2019115375A3 (enExample) 2021-03-19
US10894991B2 (en) 2021-01-19
BR112019007835A2 (pt) 2019-10-01
TW201827830A (zh) 2018-08-01
AU2017345412A1 (en) 2019-04-18

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