DK3044339T3 - Fremgangsmåder og sæt til kvantificering af fjernelsen af falske (MOCK) viruspartikler fra en renset opløsning - Google Patents
Fremgangsmåder og sæt til kvantificering af fjernelsen af falske (MOCK) viruspartikler fra en renset opløsning Download PDFInfo
- Publication number
- DK3044339T3 DK3044339T3 DK14843784.1T DK14843784T DK3044339T3 DK 3044339 T3 DK3044339 T3 DK 3044339T3 DK 14843784 T DK14843784 T DK 14843784T DK 3044339 T3 DK3044339 T3 DK 3044339T3
- Authority
- DK
- Denmark
- Prior art keywords
- mock
- fake
- quantifying
- kits
- removal
- Prior art date
Links
- 241000700605 Viruses Species 0.000 title 1
- 239000002245 particle Substances 0.000 title 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/23—Parvoviridae, e.g. feline panleukopenia virus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
- A61K2039/5258—Virus-like particles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/21—Retroviridae, e.g. equine infectious anemia virus
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2740/00—Reverse transcribing RNA viruses
- C12N2740/00011—Details
- C12N2740/10011—Retroviridae
- C12N2740/10023—Virus like particles [VLP]
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14023—Virus like particles [VLP]
-
- 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
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/158—Expression markers
-
- 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
- G01N2333/01—DNA viruses
- G01N2333/015—Parvoviridae, e.g. feline panleukopenia virus, human Parvovirus
-
- 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
- G01N2333/08—RNA viruses
- G01N2333/15—Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus, feline leukaemia virus, human T-cell leukaemia-lymphoma virus
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Virology (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Microbiology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Mycology (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Biochemistry (AREA)
- Biotechnology (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Cell Biology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Pathology (AREA)
- Peptides Or Proteins (AREA)
- Organic Chemistry (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Wood Science & Technology (AREA)
- Biophysics (AREA)
- Communicable Diseases (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361875729P | 2013-09-10 | 2013-09-10 | |
| PCT/IB2014/064352 WO2015036917A2 (en) | 2013-09-10 | 2014-09-09 | Methods and kits for quantifying the removal of mock virus particles from a purified solution |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3044339T3 true DK3044339T3 (da) | 2019-08-12 |
Family
ID=52625972
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14843784.1T DK3044339T3 (da) | 2013-09-10 | 2014-09-09 | Fremgangsmåder og sæt til kvantificering af fjernelsen af falske (MOCK) viruspartikler fra en renset opløsning |
Country Status (7)
| Country | Link |
|---|---|
| US (4) | US9632087B2 (https=) |
| EP (1) | EP3044339B1 (https=) |
| JP (2) | JP6549126B2 (https=) |
| CN (1) | CN105899684B (https=) |
| AU (3) | AU2014320015B2 (https=) |
| DK (1) | DK3044339T3 (https=) |
| WO (1) | WO2015036917A2 (https=) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9632087B2 (en) | 2013-09-10 | 2017-04-25 | MockV Solutions | Methods for evaluating viral clearance from a biopharmaceutical solution employing mock viral particles |
| EP3882627B1 (en) * | 2018-11-14 | 2024-07-10 | Nissan Chemical Corporation | Container and method for storing, pretreating, and analyzing biomaterial |
| 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 |
| US12203914B2 (en) | 2020-11-12 | 2025-01-21 | Sartorius Bioanalytical Instruments, Inc. | Viral clearance evaluation for biological medical product preparation processes |
| CN118465260B (zh) * | 2024-07-09 | 2024-10-15 | 浙江康佰裕生物科技有限公司 | 测定逆转录病毒包膜蛋白elisa方法的建立及应用 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU7966987A (en) * | 1986-09-08 | 1988-04-07 | Applied Biotechnology, Inc. | Empty viral capsid vaccines |
| US5173399A (en) * | 1988-06-10 | 1992-12-22 | Abbott Laboratories | Mouse monoclonal antibodies to hiv-1p24 and their use in diagnostic tests |
| IL92298A (en) * | 1988-11-14 | 2001-04-30 | Us Secretary U S Dept Of Comme | Method for producing isolated empty b19 parvovirus capsids, introducing genes into cells utilizing the same, diagnostic assays for detecting parvovirus infection and an anti-parvovirus vaccine containing said capsids |
| WO1993000103A1 (en) * | 1991-06-21 | 1993-01-07 | The Wistar Institute Of Anatomy And Biology | Chimeric envelope proteins for viral targeting |
| US5814442A (en) * | 1994-06-10 | 1998-09-29 | Georgetown University | Internally controlled virion nucleic acid amplification reaction for quantitation of virion and virion nucleic acid |
| EP1268841A4 (en) | 2000-03-27 | 2005-03-09 | Smithkline Beecham Corp | DETECTING VIABLE AGENTS |
| EP1170367A1 (en) * | 2000-06-27 | 2002-01-09 | Bayer Ag | BVDV virus-like particles |
| US20040002058A1 (en) * | 2001-06-21 | 2004-01-01 | Uab Research Foundation | Chimeric capsid proteins and uses thereof |
| US7041444B2 (en) * | 2003-01-14 | 2006-05-09 | Washington University | Murine calicivirus |
| US20050196381A1 (en) * | 2003-09-09 | 2005-09-08 | Xiaobin Lu | Lentivirus vector-based approaches for generating an immune response to HIV in humans |
| EP1973608A1 (en) * | 2005-12-14 | 2008-10-01 | Cytos Biotechnology AG | Immunostimulatory nucleic acid packaged particles for the treatment of hypersensitivity |
| WO2007146197A1 (en) * | 2006-06-09 | 2007-12-21 | Xing-Xiang Li | Methods and reagents for virus isolation and detection |
| WO2008036899A2 (en) * | 2006-09-22 | 2008-03-27 | Amgen Inc. | Methods for removing viral contaminants during protein purification |
| EP2198020B1 (en) * | 2007-09-14 | 2016-04-13 | Institut Pasteur | Polynucleotides allowing the expression and secretion of recombinant pseudo-virus containing foreign epitopes, their production, and use |
| GB0803068D0 (en) * | 2008-02-20 | 2008-03-26 | Health Prot Agency | Cross-linked biological indicator |
| MX2011004201A (es) * | 2008-10-20 | 2011-05-24 | Abbott Lab | Desactivacion viral durante purificacion de anticuerpos. |
| BR112012025364A2 (pt) * | 2010-04-07 | 2015-09-22 | Novartis Ag | método para geração de partícula semelhante a vírus de parvovírus b19 |
| 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 |
| US9632087B2 (en) * | 2013-09-10 | 2017-04-25 | MockV Solutions | Methods for evaluating viral clearance from a biopharmaceutical solution employing mock viral particles |
-
2014
- 2014-09-09 US US14/481,364 patent/US9632087B2/en active Active
- 2014-09-09 JP JP2016539674A patent/JP6549126B2/ja active Active
- 2014-09-09 AU AU2014320015A patent/AU2014320015B2/en active Active
- 2014-09-09 EP EP14843784.1A patent/EP3044339B1/en active Active
- 2014-09-09 WO PCT/IB2014/064352 patent/WO2015036917A2/en not_active Ceased
- 2014-09-09 DK DK14843784.1T patent/DK3044339T3/da active
- 2014-09-09 CN CN201480049583.5A patent/CN105899684B/zh active Active
-
2017
- 2017-03-11 US US15/456,487 patent/US10309963B2/en active Active
-
2019
- 2019-04-17 US US16/386,327 patent/US11754565B2/en active Active
- 2019-06-26 JP JP2019118216A patent/JP2019195333A/ja not_active Withdrawn
-
2021
- 2021-01-27 AU AU2021200484A patent/AU2021200484B2/en active Active
-
2023
- 2023-06-21 US US18/212,606 patent/US12553894B2/en active Active
- 2023-09-12 AU AU2023229501A patent/AU2023229501B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| WO2015036917A2 (en) | 2015-03-19 |
| JP2016529908A (ja) | 2016-09-29 |
| AU2014320015B2 (en) | 2020-10-29 |
| AU2021200484A1 (en) | 2021-02-25 |
| AU2023229501B2 (en) | 2025-04-03 |
| JP6549126B2 (ja) | 2019-07-31 |
| US20150072339A1 (en) | 2015-03-12 |
| US9632087B2 (en) | 2017-04-25 |
| AU2023229501A1 (en) | 2023-09-28 |
| EP3044339B1 (en) | 2019-05-22 |
| EP3044339A4 (en) | 2017-04-26 |
| WO2015036917A3 (en) | 2015-12-03 |
| CN105899684A (zh) | 2016-08-24 |
| CN105899684B (zh) | 2021-06-11 |
| US12553894B2 (en) | 2026-02-17 |
| AU2021200484B2 (en) | 2023-06-29 |
| AU2014320015A1 (en) | 2016-03-31 |
| US10309963B2 (en) | 2019-06-04 |
| US11754565B2 (en) | 2023-09-12 |
| JP2019195333A (ja) | 2019-11-14 |
| US20240085419A1 (en) | 2024-03-14 |
| US20170192001A1 (en) | 2017-07-06 |
| US20190353656A1 (en) | 2019-11-21 |
| EP3044339A2 (en) | 2016-07-20 |
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