MX385466B - Validacion de aclaramiento viral continuo. - Google Patents

Validacion de aclaramiento viral continuo.

Info

Publication number
MX385466B
MX385466B MX2019004540A MX2019004540A MX385466B MX 385466 B MX385466 B MX 385466B MX 2019004540 A MX2019004540 A MX 2019004540A MX 2019004540 A MX2019004540 A MX 2019004540A MX 385466 B MX385466 B MX 385466B
Authority
MX
Mexico
Prior art keywords
viral clearance
probe
validation
continuous viral
continuous
Prior art date
Application number
MX2019004540A
Other languages
English (en)
Spanish (es)
Other versions
MX2019004540A (es
Inventor
Benjamin Maiser
Laura David
Martin Lobedann
Peter Schwan
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 MX2019004540A publication Critical patent/MX2019004540A/es
Publication of MX385466B publication Critical patent/MX385466B/es

Links

Classifications

    • 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
    • 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)
  • 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)
MX2019004540A 2016-10-21 2017-10-19 Validacion de aclaramiento viral continuo. MX385466B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
MX2019004540A MX2019004540A (es) 2019-06-12
MX385466B true MX385466B (es) 2025-03-18

Family

ID=57209212

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019004540A MX385466B (es) 2016-10-21 2017-10-19 Validacion de aclaramiento viral continuo.

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
US20190022654A1 (en) * 2017-07-10 2019-01-24 Baxalta Incorporated Method for incubating liquids
JP7390466B2 (ja) * 2020-02-28 2023-12-01 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
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

Also Published As

Publication number Publication date
TW201827830A (zh) 2018-08-01
WO2018075716A1 (en) 2018-04-26
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
JP2019537435A (ja) 2019-12-26
MX2019004540A (es) 2019-06-12
CN110100008A (zh) 2019-08-06
CA3041253A1 (en) 2018-04-26
RU2019115375A (ru) 2020-11-23

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