HRP20160554T1 - Analitički postupak za molekule fab i fab' - Google Patents
Analitički postupak za molekule fab i fab' Download PDFInfo
- Publication number
- HRP20160554T1 HRP20160554T1 HRP20160554TT HRP20160554T HRP20160554T1 HR P20160554 T1 HRP20160554 T1 HR P20160554T1 HR P20160554T T HRP20160554T T HR P20160554TT HR P20160554 T HRP20160554 T HR P20160554T HR P20160554 T1 HRP20160554 T1 HR P20160554T1
- Authority
- HR
- Croatia
- Prior art keywords
- fab
- peg
- cleavage
- linker
- carried out
- Prior art date
Links
- 238000004458 analytical method Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 8
- 238000003776 cleavage reaction Methods 0.000 claims 4
- 230000007017 scission Effects 0.000 claims 4
- 230000002378 acidificating effect Effects 0.000 claims 3
- 108090000790 Enzymes Proteins 0.000 claims 2
- 102000004190 Enzymes Human genes 0.000 claims 2
- 239000004472 Lysine Substances 0.000 claims 2
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims 2
- 239000004473 Threonine Substances 0.000 claims 2
- AYFVYJQAPQTCCC-UHFFFAOYSA-N Threonine Natural products CC(O)C(N)C(O)=O AYFVYJQAPQTCCC-UHFFFAOYSA-N 0.000 claims 2
- 210000004899 c-terminal region Anatomy 0.000 claims 2
- 238000005277 cation exchange chromatography Methods 0.000 claims 2
- 229940088598 enzyme Drugs 0.000 claims 2
- 238000000926 separation method Methods 0.000 claims 2
- 108090000317 Chymotrypsin Proteins 0.000 claims 1
- 108090000631 Trypsin Proteins 0.000 claims 1
- 102000004142 Trypsin Human genes 0.000 claims 1
- 230000015556 catabolic process Effects 0.000 claims 1
- 229960002376 chymotrypsin Drugs 0.000 claims 1
- 238000006731 degradation reaction Methods 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 238000011002 quantification Methods 0.000 claims 1
- 238000004445 quantitative analysis Methods 0.000 claims 1
- 238000001542 size-exclusion chromatography Methods 0.000 claims 1
- 239000012588 trypsin Substances 0.000 claims 1
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
- C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
- C12Q1/37—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving peptidase or proteinase
-
- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
-
- 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
-
- 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
- G01N33/563—Immunoassay; Biospecific binding assay; Materials therefor involving antibody fragments
-
- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
- G01N33/6857—Antibody fragments
-
- 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
- G01N2333/90—Enzymes; Proenzymes
- G01N2333/914—Hydrolases (3)
- G01N2333/948—Hydrolases (3) acting on peptide bonds (3.4)
- G01N2333/95—Proteinases, i.e. endopeptidases (3.4.21-3.4.99)
- G01N2333/964—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue
- G01N2333/96425—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals
- G01N2333/96427—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general
- G01N2333/9643—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general with EC number
- G01N2333/96433—Serine endopeptidases (3.4.21)
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Food Science & Technology (AREA)
- Cell Biology (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Peptides Or Proteins (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Claims (8)
1. Postupak mjerenja kiselih vrsta stvorenih degradacijom Fab' komponente iz Fab'-PEG naznačen time da sadrži korake:
a) cijepanje PEG i linkera iz Fab'-PEG s enzimom koji cijepa spojnog dijela Fab' i otpušta PEG i linker iz Fab',
b) razdvajanje PEG i linkera nastalog u koraku a) iz Fab', da se dobije Fab' i
c) kvantitativnu analizu kiselih vrsta povezanih sa cijepanjem Fab'.
2. Postupak prema zahtjevu 1, naznačen time da enzim je tripsin ili kimotripsin.
3. Postupak prema zahtjevu 1 ili 2 naznačen time da se korak cijepanja a) provodi kod temperature u rasponu od 25 do 40°C, kao što je 37°C.
4. Postupak prema bilo kojem od zahtjeva 1 do 3, naznačen time da se cijepanja iz koraka a) odvija između lizina i treonina, naročito na C-terminalnom kraju Fab' teškog lanca.
5. Postupak prema zahtjevu 4, naznačen time da se lizin i treonin nalaze u sekvenci SCDKTHTCAA smještenoj na C-terminalnom kraju Fab'.
6. Postupak prema zahtjevu 1, naznačen time da se razdvajanje provodi pomoću kationske izmjenjivačke kromatografije, clEF, i/ili kromatografija isključivanja po veličini.
7. Postupak prema bilo kojem od zahtjeva 1 do 6, naznačen time da se kvantifikacija kiselih vrsta provodi korištenjem kationske izmjenjivačke kromatografije ili kapilarne izoelektroforeze, kao što je CEX-HPLC.
8. Postupak prema bilo kojem od zahtjeva 1 do 7, naznačen time da Fab' sadrži ili se sastoji od SEQ ID NO:10.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1012784.3A GB201012784D0 (en) | 2010-07-29 | 2010-07-29 | Method |
| EP11744051.1A EP2598888B1 (en) | 2010-07-29 | 2011-07-28 | Analytical method for fab and fab' molecules |
| PCT/GB2011/001135 WO2012013933A1 (en) | 2010-07-29 | 2011-07-28 | Analytical method for fab and fab' molecules |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20160554T1 true HRP20160554T1 (hr) | 2016-07-01 |
Family
ID=42799323
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20160554TT HRP20160554T1 (hr) | 2010-07-29 | 2016-05-23 | Analitički postupak za molekule fab i fab' |
Country Status (22)
| Country | Link |
|---|---|
| US (2) | US8722353B2 (hr) |
| EP (1) | EP2598888B1 (hr) |
| JP (1) | JP6122777B2 (hr) |
| KR (1) | KR20130143549A (hr) |
| CN (1) | CN103229058B (hr) |
| AU (1) | AU2011284551B2 (hr) |
| BR (1) | BR112013001160A2 (hr) |
| CA (1) | CA2805573A1 (hr) |
| CY (1) | CY1117709T1 (hr) |
| DK (1) | DK2598888T3 (hr) |
| ES (1) | ES2574906T3 (hr) |
| GB (1) | GB201012784D0 (hr) |
| HK (1) | HK1187674A1 (hr) |
| HR (1) | HRP20160554T1 (hr) |
| HU (1) | HUE027631T2 (hr) |
| IL (1) | IL224176A (hr) |
| PL (1) | PL2598888T3 (hr) |
| PT (1) | PT2598888E (hr) |
| SG (1) | SG187545A1 (hr) |
| SI (1) | SI2598888T1 (hr) |
| SM (1) | SMT201600173B (hr) |
| WO (1) | WO2012013933A1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201012784D0 (en) * | 2010-07-29 | 2010-09-15 | Ucb Pharma Sa | Method |
| CN105548422B (zh) * | 2015-12-23 | 2018-04-20 | 先健科技(深圳)有限公司 | 一种聚乙二醇含量的检测方法 |
| CN108760962A (zh) * | 2018-05-04 | 2018-11-06 | 上海药明生物技术有限公司 | Fab或Fab’含量的测定方法及应用 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0013810D0 (en) * | 2000-06-06 | 2000-07-26 | Celltech Chiroscience Ltd | Biological products |
| WO2003080674A1 (en) * | 2002-03-20 | 2003-10-02 | Pharmacia Corporation | Antibody disulfide isomers, use thereof, and methods of analyzing same |
| WO2005059106A2 (en) * | 2003-12-10 | 2005-06-30 | Medarex, Inc. | Interferon alpha antibodies and their uses |
| CL2007002502A1 (es) * | 2006-08-31 | 2008-05-30 | Hoffmann La Roche | Variantes del factor de crecimiento similar a insulina-1 humano (igf-1) pegilados en lisina; metodo de produccion; proteina de fusion que la comprende; y su uso para tratar la enfermedad de alzheimer. |
| GB201012784D0 (en) * | 2010-07-29 | 2010-09-15 | Ucb Pharma Sa | Method |
-
2010
- 2010-07-29 GB GBGB1012784.3A patent/GB201012784D0/en not_active Ceased
-
2011
- 2011-07-28 CN CN201180036182.2A patent/CN103229058B/zh not_active Expired - Fee Related
- 2011-07-28 HU HUE11744051A patent/HUE027631T2/en unknown
- 2011-07-28 JP JP2013521209A patent/JP6122777B2/ja active Active
- 2011-07-28 US US13/812,692 patent/US8722353B2/en not_active Expired - Fee Related
- 2011-07-28 PT PT117440511T patent/PT2598888E/pt unknown
- 2011-07-28 DK DK11744051.1T patent/DK2598888T3/en active
- 2011-07-28 PL PL11744051.1T patent/PL2598888T3/pl unknown
- 2011-07-28 SG SG2013003538A patent/SG187545A1/en unknown
- 2011-07-28 CA CA2805573A patent/CA2805573A1/en not_active Abandoned
- 2011-07-28 WO PCT/GB2011/001135 patent/WO2012013933A1/en active Application Filing
- 2011-07-28 SI SI201130837A patent/SI2598888T1/sl unknown
- 2011-07-28 ES ES11744051.1T patent/ES2574906T3/es active Active
- 2011-07-28 KR KR1020137003642A patent/KR20130143549A/ko not_active Application Discontinuation
- 2011-07-28 AU AU2011284551A patent/AU2011284551B2/en not_active Ceased
- 2011-07-28 BR BR112013001160-2A patent/BR112013001160A2/pt not_active IP Right Cessation
- 2011-07-28 EP EP11744051.1A patent/EP2598888B1/en active Active
-
2013
- 2013-01-10 IL IL224176A patent/IL224176A/en active IP Right Grant
-
2014
- 2014-01-17 HK HK14100552.4A patent/HK1187674A1/zh not_active IP Right Cessation
- 2014-05-12 US US14/275,055 patent/US9096887B2/en not_active Expired - Fee Related
-
2016
- 2016-05-23 HR HRP20160554TT patent/HRP20160554T1/hr unknown
- 2016-06-15 CY CY20161100528T patent/CY1117709T1/el unknown
- 2016-06-16 SM SM201600173T patent/SMT201600173B/it unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2012013933A1 (en) | 2012-02-02 |
| US8722353B2 (en) | 2014-05-13 |
| HUE027631T2 (en) | 2016-10-28 |
| IL224176A (en) | 2015-10-29 |
| EP2598888A1 (en) | 2013-06-05 |
| CN103229058B (zh) | 2015-07-29 |
| JP6122777B2 (ja) | 2017-04-26 |
| SI2598888T1 (sl) | 2016-07-29 |
| AU2011284551A1 (en) | 2013-01-31 |
| AU2011284551B2 (en) | 2016-04-07 |
| US20140242625A1 (en) | 2014-08-28 |
| DK2598888T3 (en) | 2016-06-20 |
| JP2013533490A (ja) | 2013-08-22 |
| US9096887B2 (en) | 2015-08-04 |
| PT2598888E (pt) | 2016-06-23 |
| GB201012784D0 (en) | 2010-09-15 |
| ES2574906T3 (es) | 2016-06-23 |
| EP2598888B1 (en) | 2016-03-16 |
| CY1117709T1 (el) | 2017-05-17 |
| CA2805573A1 (en) | 2012-02-02 |
| BR112013001160A2 (pt) | 2021-03-30 |
| CN103229058A (zh) | 2013-07-31 |
| KR20130143549A (ko) | 2013-12-31 |
| US20130183703A1 (en) | 2013-07-18 |
| SG187545A1 (en) | 2013-03-28 |
| HK1187674A1 (zh) | 2014-04-11 |
| PL2598888T3 (pl) | 2016-10-31 |
| SMT201600173B (it) | 2016-08-31 |
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