CA3041253A1 - Validation of continuous viral clearance - Google Patents
Validation of continuous viral clearance Download PDFInfo
- Publication number
- CA3041253A1 CA3041253A1 CA3041253A CA3041253A CA3041253A1 CA 3041253 A1 CA3041253 A1 CA 3041253A1 CA 3041253 A CA3041253 A CA 3041253A CA 3041253 A CA3041253 A CA 3041253A CA 3041253 A1 CA3041253 A1 CA 3041253A1
- Authority
- CA
- Canada
- Prior art keywords
- sampling
- viral
- probe
- cfi
- continuous
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
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- 238000010200 validation analysis Methods 0.000 title claims abstract description 33
- 238000000034 method Methods 0.000 claims abstract description 77
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- 238000012421 spiking Methods 0.000 claims abstract description 20
- 230000002779 inactivation Effects 0.000 claims description 39
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- 239000002245 particle Substances 0.000 claims description 18
- 108090000623 proteins and genes Proteins 0.000 claims description 17
- 102000004169 proteins and genes Human genes 0.000 claims description 17
- 238000010924 continuous production Methods 0.000 claims description 14
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- 238000011002 quantification Methods 0.000 claims description 6
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- VEZXCJBBBCKRPI-UHFFFAOYSA-N beta-propiolactone Chemical compound O=C1CCO1 VEZXCJBBBCKRPI-UHFFFAOYSA-N 0.000 description 1
- 230000031018 biological processes and functions Effects 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
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- 238000001727 in vivo Methods 0.000 description 1
- 230000000415 inactivating effect Effects 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 229910052740 iodine Inorganic materials 0.000 description 1
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- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 229960000380 propiolactone Drugs 0.000 description 1
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- 238000003753 real-time PCR Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
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- STCOOQWBFONSKY-UHFFFAOYSA-N tributyl phosphate Chemical compound CCCCOP(=O)(OCCCC)OCCCC STCOOQWBFONSKY-UHFFFAOYSA-N 0.000 description 1
- 230000029812 viral genome replication Effects 0.000 description 1
- 239000011534 wash buffer Substances 0.000 description 1
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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
- 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
-
- 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)
- General Health & Medical Sciences (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Public Health (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)
- Investigating Or Analysing Biological Materials (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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 |
|---|---|
| CA3041253A1 true CA3041253A1 (en) | 2018-04-26 |
Family
ID=57209212
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3041253A Abandoned CA3041253A1 (en) | 2016-10-21 | 2017-10-19 | Validation of continuous viral clearance |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US10894991B2 (enExample) |
| EP (2) | EP3141611A3 (enExample) |
| JP (1) | JP2019537435A (enExample) |
| KR (1) | KR20190066017A (enExample) |
| CN (1) | CN110100008A (enExample) |
| AR (1) | AR109846A1 (enExample) |
| AU (1) | AU2017345412A1 (enExample) |
| BR (1) | BR112019007835A2 (enExample) |
| CA (1) | CA3041253A1 (enExample) |
| IL (1) | IL266095A (enExample) |
| MX (1) | MX385466B (enExample) |
| RU (1) | RU2755634C2 (enExample) |
| SG (1) | SG10202104023QA (enExample) |
| TW (1) | TW201827830A (enExample) |
| UY (1) | UY37447A (enExample) |
| WO (1) | WO2018075716A1 (enExample) |
Families Citing this family (5)
| 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 |
| EP4317460A4 (en) * | 2021-03-26 | 2024-10-23 | Asahi Kasei Medical Co., Ltd. | Viral clearance test method |
Family Cites Families (2)
| 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 |
-
2016
- 2016-10-21 EP EP16194959.9A patent/EP3141611A3/en not_active Withdrawn
-
2017
- 2017-10-19 TW TW106135849A patent/TW201827830A/zh unknown
- 2017-10-19 RU RU2019115375A patent/RU2755634C2/ru active
- 2017-10-19 CA CA3041253A patent/CA3041253A1/en not_active Abandoned
- 2017-10-19 EP EP17791896.8A patent/EP3529367A1/en not_active Withdrawn
- 2017-10-19 JP JP2019520956A patent/JP2019537435A/ja not_active Ceased
- 2017-10-19 AU AU2017345412A patent/AU2017345412A1/en not_active Abandoned
- 2017-10-19 WO PCT/US2017/057298 patent/WO2018075716A1/en not_active Ceased
- 2017-10-19 KR KR1020197010823A patent/KR20190066017A/ko not_active Ceased
- 2017-10-19 CN CN201780064932.4A patent/CN110100008A/zh active Pending
- 2017-10-19 MX MX2019004540A patent/MX385466B/es unknown
- 2017-10-19 BR BR112019007835A patent/BR112019007835A2/pt not_active IP Right Cessation
- 2017-10-19 SG SG10202104023QA patent/SG10202104023QA/en unknown
- 2017-10-20 AR ARP170102921A patent/AR109846A1/es not_active Application Discontinuation
- 2017-10-20 US US16/343,125 patent/US10894991B2/en not_active Expired - Fee Related
- 2017-10-20 UY UY0001037447A patent/UY37447A/es not_active Application Discontinuation
-
2019
- 2019-04-17 IL IL266095A patent/IL266095A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| IL266095A (en) | 2019-06-30 |
| EP3529367A1 (en) | 2019-08-28 |
| UY37447A (es) | 2018-05-31 |
| KR20190066017A (ko) | 2019-06-12 |
| CN110100008A (zh) | 2019-08-06 |
| MX385466B (es) | 2025-03-18 |
| SG10202104023QA (en) | 2021-06-29 |
| US20190316213A1 (en) | 2019-10-17 |
| RU2019115375A (ru) | 2020-11-23 |
| AR109846A1 (es) | 2019-01-30 |
| EP3141611A3 (en) | 2017-05-10 |
| RU2755634C2 (ru) | 2021-09-17 |
| WO2018075716A1 (en) | 2018-04-26 |
| MX2019004540A (es) | 2019-06-12 |
| EP3141611A2 (en) | 2017-03-15 |
| JP2019537435A (ja) | 2019-12-26 |
| RU2019115375A3 (enExample) | 2021-03-19 |
| US10894991B2 (en) | 2021-01-19 |
| BR112019007835A2 (pt) | 2019-10-01 |
| TW201827830A (zh) | 2018-08-01 |
| AU2017345412A1 (en) | 2019-04-18 |
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