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
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Ceased
Application number
JP2019520956A
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English (en)
Japanese (ja)
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JP2019537435A5 (https=
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
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Bayer AG
Original Assignee
Bayer AG
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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
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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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials
    • 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)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (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)
  • Investigating Or Analysing Biological Materials (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
EP16194959.9 2016-10-21
EP16194959.9A EP3141611A3 (en) 2016-10-21 2016-10-21 Validation of continuous viral clearance
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 (https=) 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 (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=)

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
WO2022203044A1 (ja) * 2021-03-26 2022-09-29 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
US9644187B2 (en) * 2010-04-14 2017-05-09 Emd Millipore Corporation Methods of producing high titer, high purity virus stocks and methods of use thereof
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
TW201827830A (zh) 2018-08-01
WO2018075716A1 (en) 2018-04-26
MX385466B (es) 2025-03-18
EP3141611A3 (en) 2017-05-10
BR112019007835A2 (pt) 2019-10-01
SG10202104023QA (en) 2021-06-29
KR20190066017A (ko) 2019-06-12
AR109846A1 (es) 2019-01-30
IL266095A (en) 2019-06-30
US20190316213A1 (en) 2019-10-17
EP3141611A2 (en) 2017-03-15
AU2017345412A1 (en) 2019-04-18
RU2755634C2 (ru) 2021-09-17
RU2019115375A3 (https=) 2021-03-19
EP3529367A1 (en) 2019-08-28
US10894991B2 (en) 2021-01-19
UY37447A (es) 2018-05-31
MX2019004540A (es) 2019-06-12
CN110100008A (zh) 2019-08-06
CA3041253A1 (en) 2018-04-26
RU2019115375A (ru) 2020-11-23

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