RU2755634C2 - Валидация очищения вируса в непрерывном режиме - Google Patents

Валидация очищения вируса в непрерывном режиме Download PDF

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RU2755634C2
RU2755634C2 RU2019115375A RU2019115375A RU2755634C2 RU 2755634 C2 RU2755634 C2 RU 2755634C2 RU 2019115375 A RU2019115375 A RU 2019115375A RU 2019115375 A RU2019115375 A RU 2019115375A RU 2755634 C2 RU2755634 C2 RU 2755634C2
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sample
stream
additive
cfi
sampling
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RU2019115375A
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RU2019115375A (ru
RU2019115375A3 (https=
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Бенджамин МАЙЗЕР
Петер ШВАН
Лаура ДАВИД
Мартин ЛОБЕДАНН
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Байер Акциенгезельшафт
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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

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  • 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)
RU2019115375A 2016-10-21 2017-10-19 Валидация очищения вируса в непрерывном режиме RU2755634C2 (ru)

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 (3)

Publication Number Publication Date
RU2019115375A RU2019115375A (ru) 2020-11-23
RU2019115375A3 RU2019115375A3 (https=) 2021-03-19
RU2755634C2 true RU2755634C2 (ru) 2021-09-17

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RU2019115375A RU2755634C2 (ru) 2016-10-21 2017-10-19 Валидация очищения вируса в непрерывном режиме

Country Status (16)

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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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2377927A1 (en) * 2010-04-14 2011-10-19 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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2377927A1 (en) * 2010-04-14 2011-10-19 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 (1)

* Cited by examiner, † Cited by third party
Title
Яковлева А.С. и др. Разработка и валидация тест-системы ЗАВ-ИФА для обнаружения антител к неструктурным белкам вируса ящура в сыворотках крови крупного и мелкого рогатого скота, Ветеринария сегодня, 2015 номер 4. стр. 36-42. *

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
TW201827830A (zh) 2018-08-01
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

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