BR112019007835A2 - validação da depuração viral contínua - Google Patents

validação da depuração viral contínua Download PDF

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Publication number
BR112019007835A2
BR112019007835A2 BR112019007835-5A BR112019007835A BR112019007835A2 BR 112019007835 A2 BR112019007835 A2 BR 112019007835A2 BR 112019007835 A BR112019007835 A BR 112019007835A BR 112019007835 A2 BR112019007835 A2 BR 112019007835A2
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BR
Brazil
Prior art keywords
viral
sampling
probe
cfi
sample
Prior art date
Application number
BR112019007835-5A
Other languages
English (en)
Portuguese (pt)
Inventor
Maiser Benjamin
Schwan Peter
DAVID Laura
Lobedann Martin
Original Assignee
Bayer Aktiengesellschaft
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 Aktiengesellschaft filed Critical Bayer Aktiengesellschaft
Publication of BR112019007835A2 publication Critical patent/BR112019007835A2/pt

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    • 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)
  • 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)
BR112019007835-5A 2016-10-21 2017-10-19 validação da depuração viral contínua BR112019007835A2 (pt)

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 (1)

Publication Number Publication Date
BR112019007835A2 true BR112019007835A2 (pt) 2019-10-01

Family

ID=57209212

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019007835-5A BR112019007835A2 (pt) 2016-10-21 2017-10-19 validação da depuração viral contínua

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
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

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

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
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
RU2755634C2 (ru) 2021-09-17

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Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2692 DE 09-08-2022 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.