AR109846A1 - Validación de aclaramiento viral continuo - Google Patents

Validación de aclaramiento viral continuo

Info

Publication number
AR109846A1
AR109846A1 ARP170102921A ARP170102921A AR109846A1 AR 109846 A1 AR109846 A1 AR 109846A1 AR P170102921 A ARP170102921 A AR P170102921A AR P170102921 A ARP170102921 A AR P170102921A AR 109846 A1 AR109846 A1 AR 109846A1
Authority
AR
Argentina
Prior art keywords
validation
viral clearance
probe
continuous viral
continuous
Prior art date
Application number
ARP170102921A
Other languages
English (en)
Inventor
Lobedann Martin Dr
Laura Holtmann
Schwan Peter Dr
Maiser Benjamin Dr
Original Assignee
Bayer Healthcare Llc
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 Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of AR109846A1 publication Critical patent/AR109846A1/es

Links

Classifications

    • 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
    • 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
    • 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)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Public Health (AREA)
  • Epidemiology (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)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Se describe un método para la validación del aclaramiento viral continuo que comprende las etapas de a) proporcionar una sonda para su validación, b) adición de virus a la sonda en forma válida, c) realizar el aclaramiento viral, d) muestreo de la sonda a la que se han agregado virus y e) analizar la muestra de la sonda con agregado de virus de la etapa d).
ARP170102921A 2016-10-21 2017-10-20 Validación de aclaramiento viral continuo AR109846A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
AR109846A1 true AR109846A1 (es) 2019-01-30

Family

ID=57209212

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170102921A AR109846A1 (es) 2016-10-21 2017-10-20 Validación de aclaramiento viral continuo

Country Status (16)

Country Link
US (1) US10894991B2 (es)
EP (2) EP3141611A3 (es)
JP (1) JP2019537435A (es)
KR (1) KR20190066017A (es)
CN (1) CN110100008A (es)
AR (1) AR109846A1 (es)
AU (1) AU2017345412A1 (es)
BR (1) BR112019007835A2 (es)
CA (1) CA3041253A1 (es)
IL (1) IL266095A (es)
MX (1) MX2019004540A (es)
RU (1) RU2755634C2 (es)
SG (1) SG10202104023QA (es)
TW (1) TW201827830A (es)
UY (1) UY37447A (es)
WO (1) WO2018075716A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2020000353A (es) * 2017-07-10 2020-08-17 Takeda Pharmaceuticals Co Metodos para incubar liquidos e inactivar virus.
EP4112735A4 (en) * 2020-02-28 2023-09-06 Asahi Kasei Medical Co., Ltd. METHOD FOR EVALUATION OF VIRAL CLEARANCE PERFORMANCE
JP2023544512A (ja) * 2020-09-21 2023-10-24 バイエル・ヘルスケア・エルエルシー 病原体クリアランスシステムおよび方法
US20220146485A1 (en) * 2020-11-12 2022-05-12 Essen Instruments, Inc. D/B/A Essen Bioscience, Inc. Viral clearance evaluation for biological medical product preparation processes
US20240175098A1 (en) * 2021-03-26 2024-05-30 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
CN102985536B (zh) * 2010-04-14 2017-12-05 Emd密理博公司 生产高效价、高纯度的病毒母液的方法及使用其的方法
AU2014100888A4 (en) * 2014-08-07 2014-09-11 Novartis Ag Virus clearance and protein purification methods

Also Published As

Publication number Publication date
CA3041253A1 (en) 2018-04-26
AU2017345412A1 (en) 2019-04-18
WO2018075716A1 (en) 2018-04-26
MX2019004540A (es) 2019-06-12
US10894991B2 (en) 2021-01-19
JP2019537435A (ja) 2019-12-26
RU2755634C2 (ru) 2021-09-17
EP3141611A3 (en) 2017-05-10
IL266095A (en) 2019-06-30
SG10202104023QA (en) 2021-06-29
RU2019115375A (ru) 2020-11-23
UY37447A (es) 2018-05-31
CN110100008A (zh) 2019-08-06
BR112019007835A2 (pt) 2019-10-01
TW201827830A (zh) 2018-08-01
EP3529367A1 (en) 2019-08-28
RU2019115375A3 (es) 2021-03-19
EP3141611A2 (en) 2017-03-15
KR20190066017A (ko) 2019-06-12
US20190316213A1 (en) 2019-10-17

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