DK2271670T3 - Immunbaserede aktivitetsassays med botulinumtoksin serotype a - Google Patents
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- DK2271670T3 DK2271670T3 DK09719709.9T DK09719709T DK2271670T3 DK 2271670 T3 DK2271670 T3 DK 2271670T3 DK 09719709 T DK09719709 T DK 09719709T DK 2271670 T3 DK2271670 T3 DK 2271670T3
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/12—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
- C07K16/1267—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-positive bacteria
- C07K16/1282—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-positive bacteria from Clostridium (G)
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- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
- C07K14/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- C07—ORGANIC CHEMISTRY
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- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
- C07K14/08—RNA viruses
- C07K14/085—Picornaviridae, e.g. coxsackie virus, echovirus, enterovirus
- C07K14/10—Hepatitis A virus
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- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/12—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- 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
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- 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
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
- G01N33/5014—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing toxicity
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- 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
- G01N33/566—Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds
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- 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
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- 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
- G01N33/56911—Bacteria
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- 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
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C07—ORGANIC CHEMISTRY
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/77—Internalization into the cell
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- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- 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
- G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
- G01N2333/33—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Clostridium (G)
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- G—PHYSICS
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- 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
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants
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- 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)
- G01N2333/952—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from bacteria
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Claims (11)
- IMMUNBASEREDE AKTIVITETS ASS AYS MED BOTULINUMTOKSIN SEROTYPE A1. Fremgangsmåde til detektering af BoNT/A-aktivitet, hvilken fremgangsmåde omfatter trinene: a. behandling af en celle fra en etableret cellelinje med en prøve, der omfatter et BoNT/A, hvor cellen fra en etableret cellelinje er modtagelig for BoNT/A-intoksikation ved ca. 500 pM eller mindre af et BoNT/A, og hvor cellen er udvalgt fra gruppen, der består af SiMa-cellelinjen (DSMZ-nr. ACC 164), Neuro-2a-cellelinjen (ATCC-katalognr. CCL-131™), N18 (ECACC-nr. 88112301), LAl-55n (ECACC-nr. 06041203), PC12 (ATCC-katalognr. CRL-1721™) og SH-SY5Y (ATCC-katalognr. CRL-2266™); b. isolering fra den behandlede celle af en SNAP-25-bestanddel, der omfatter et SNAP-25-spaltningsprodukt, der har en carboxylterminal glutamin fra BoNT/A-spaltningsstedets spaltelige binding; c. etablering af kontakt mellem SNAP-25-bestanddelen og et a-SNAP-25-antistof, der er koblet til en fastfaseunderstøtning, hvilket a-SNAP-25-antistof binder en epitop, der omfatter en carboxylterminal glutamin fra BoNT/A-spaltningsstedets spaltelige binding, fra et SNAP-25-spaltningsprodukt, og hvilket a-SNAP-25-antistof har en associationshastighedskonstant for det intakte SNAP25 på mindre end 1 x 101 M"1 s"1; og a-SNAP-25-antistoffet har en ligevægtsdisassociationskonstant for epitopen på mindre end 0,450 nM, d. detektering af tilstedeværelse af et antistof-antigenkompleks, der omfatter a-SNAP-25-antistoffet og SNAP-25-spaltningsproduktet, der har en carboxylterminal glutamin fra BoNT/A-spaltningsstedets spaltelige binding; hvor detektion af antistof-antigenkomplekset er tegn på BoNT/A-aktivitet.
- 2. Fremgangsmåde ifølge krav 1, hvor SNAP-25-spaltningsproduktet er SNAP-25197.
- 3. Fremgangsmåde ifølge krav 1 eller 2, hvor tilstedeværelsen af et antistof-antigenkompleks detekteres ved anvendelse af et sandwich-ELISA.
- 4. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3, hvor fremgangsmåden har et signal/støj-forhold ved den nedre asymptote på mindst 3:1 og et signal/støj-forhold ved den øvre upper asymptote på mindst 10:1.
- 5. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 4, hvor prøven omfatter højst 100 pM af et BoNT/A
- 6. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 5, hvor cellen fra en etableret cellelinje er modtagelig for BoNT/A-intoksikation ved ca. 100 pM eller mindre af et BoNT/A.
- 7. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 6, hvor fremgangsmåden udføres på en singlepleks eller en multipleks måde.
- 8. Fremgangsmåde til bestemmelse af BoNT/A-immunresistens hos et pattedyr, der omfatter trinene: a. tilsætning af et BoNT/A til en testprøve, der er opnået fra et pattedyr, der testes for tilstedeværelse eller fravær af a-BoNT/A-neutraliserende antistoffer; b. behandling af en celle fra en etableret cellelinje med testprøven, hvor cellen fra en etableret cellelinje er modtagelig for BoNT/A-intoksikation, og hvor cellen er udvalgt fra gruppen, der består af SiMa-cellelinjen (DSMZ-nr. ACC 164), Neuro-2a-cellelinjen (ATCC-katalognr. CCL-131™), N18 (ECACC-nr. 88112301), LAl-55n (ECACC-nr. 06041203), PC12 (ATCC-katalognr. CRL-1721™) og SH-SY5Y (ATCC-katalognr. CRL-2266™); c. isolering fra de behandlede celler af en SNAP-25-bestanddel, der omfatter et SNAP-25-spaltningsprodukt, der har en carboxylterminal glutamin fra BoNT/A-spaltningsstedets spaltelige binding; d. etablering af kontakt mellem SNAP-25-bestanddelen og et a-SNAP-25-antistof, der er koblet til en fastfaseunderstøtning; hvor a-SNAP-25-antistoffet; hvor a-SNAP-25-antistoffet binder en epitop, der omfatter en carboxylterminal glutamin fra BoNT/A-spaltningsstedets spaltelige binding, fra et SNAP-25-spaltningsprodukt, a-SNAP-25-antistoffet har en associationshastighedskonstant for det intakte SNAP25 på mindre end 1 x 101 M_1 s'1; og a-SNAP-25-antistoffet har en ligevægtsdisassociationskonstant for epitopen på mindre end 0,450 nM. e. detektering af tilstedeværelse af et antistof-antigenkompleks, der omfatter a-SNAP-25-antistoffet og SNAP-25-spaltningsproduktet, der har en carboxylterminal glutamin fra BoNT/A-spaltningsstedets spaltelige binding; f. gentagelse af trinene b-e med en negativ kontrolprøve i stedet for en testprøve, hvilken negative kontrolprøve omfatter et BoNT/A og et serum, som man ved ikke indeholder α-BoNT/A-neutraliserende antistoffer; og g. sammenligning af mængden af antistof-antigenkompleks, der er detekteret i trin e, med mængden af antistof-antigenkompleks, der er detekteret i trin f, hvor detektion af en lavere mængde af antistof-antigenkompleks, der er detekteret i trin e, i forhold til mængden af antistof-antigenkompleks, der er detekteret i trin f, er tegn på tilstedeværelse af a-BoNT/A-neutraliserende antistoffer.
- 9. Fremgangsmåde ifølge et hvilket som helst af kravene 1-8, hvor det monoklonale a-SNAP-25-antistof omfatter mindst et Vh-CDR3 ifølge SEQ ID NO: 100, et VH-CDR3 ifølge SEQ ID NO: 101 eller et VH-CDR3 ifølge SEQ ID NO: 102.
- 10. Fremgangsmåde ifølge et hvilket som helst af kravene 1-8, hvor a-SNAP-25-antistoffet omfatter a. et tungkæde-variabelt område, der omfatter SEQ ID NO: 72, SEQ ID NO: 74, SEQ ID NO: 76, SEQ ID NO: 80 eller SEQ ID NO: 82; og b. et letkæde-variabelt område, der omfatter SEQ ID NO: 84, SEQ ID NO: 86, SEQ ID NO: 88, SEQ ID NO: 90 eller SEQ ID NO: 92.
- 11 .Fremgangsmåde ifølge et hvilket som helst af kravene 1-8, hvor a. et tungkæde-variabelt område omfatter SEQ ID NO: 93, SEQ ID NO: 121 eller SEQ ID NO: 100; og b. et letkæde-variabelt område omfatter SEQ ID NO: 105, SEQ ID NO: 110 eller SEQ ID NO: 115.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US3672308P | 2008-03-14 | 2008-03-14 | |
PCT/US2009/037046 WO2009114748A1 (en) | 2008-03-14 | 2009-03-13 | Immuno-based botulinum toxin serotype a activity assays |
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DK2271670T3 true DK2271670T3 (da) | 2014-12-01 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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DK16153819T DK3031825T3 (da) | 2008-03-14 | 2009-03-13 | Immunbaserede aktivitetsassays for botulinum-toxin serotype a |
DK09719709.9T DK2271670T3 (da) | 2008-03-14 | 2009-03-13 | Immunbaserede aktivitetsassays med botulinumtoksin serotype a |
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DK16153819T DK3031825T3 (da) | 2008-03-14 | 2009-03-13 | Immunbaserede aktivitetsassays for botulinum-toxin serotype a |
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US (11) | US8198034B2 (da) |
EP (5) | EP3851451A1 (da) |
JP (5) | JP5766954B2 (da) |
KR (1) | KR101609894B1 (da) |
CN (2) | CN102937653B (da) |
AU (1) | AU2009223161B2 (da) |
BR (2) | BRPI0908578A2 (da) |
CA (1) | CA2715033C (da) |
CO (1) | CO6311001A2 (da) |
CY (2) | CY1115771T1 (da) |
DK (2) | DK3031825T3 (da) |
ES (2) | ES2755505T3 (da) |
HK (2) | HK1151298A1 (da) |
HR (1) | HRP20191886T1 (da) |
HU (1) | HUE046037T2 (da) |
IL (2) | IL208097A (da) |
LT (1) | LT3031825T (da) |
MX (1) | MX2010010137A (da) |
MY (2) | MY165032A (da) |
NZ (1) | NZ588029A (da) |
PL (2) | PL3031825T3 (da) |
PT (2) | PT3031825T (da) |
RU (2) | RU2491293C2 (da) |
SG (1) | SG2014009112A (da) |
SI (2) | SI3031825T1 (da) |
UA (1) | UA102247C2 (da) |
WO (1) | WO2009114748A1 (da) |
Families Citing this family (70)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7563874B2 (en) * | 1998-08-31 | 2009-07-21 | The Regents Of The University Of California | Therapeutic monoclonal antibodies that neutralize botulinum neurotoxins |
US8497081B2 (en) * | 2004-02-24 | 2013-07-30 | Allergan, Inc. | Botulinum toxin screening assays |
EP2134749B1 (en) | 2007-03-22 | 2013-11-06 | The Regents of the University of California | Therapeutic monoclonal antibodies that neutralize botulinum neurotoxins |
US8540987B2 (en) * | 2008-01-29 | 2013-09-24 | Institute For Antibodies Co., Ltd. | Composition for neutralizing botulinus toxin type-A, and human anti-botulinus toxin type-A antibody |
SI3031825T1 (sl) | 2008-03-14 | 2019-12-31 | Allergan, Inc. | Preizkusi aktivnosti serotipa A botulin toksina na podlagi imunosti |
KR101604515B1 (ko) * | 2008-03-14 | 2016-03-17 | 알러간, 인코포레이티드 | 면역-기반 보툴리눔 독소 세로타입 a 활성 검정 |
CA2732003A1 (en) | 2008-07-31 | 2010-02-04 | James D. Marks | Antibodies that neutralize botulinum neurotoxins |
KR101923847B1 (ko) | 2009-03-13 | 2018-11-29 | 알러간, 인코포레이티드 | 면역 기반 재표적화된 엔도펩티다제 활성 검정 |
PL2406371T3 (pl) | 2009-03-13 | 2018-11-30 | Allergan, Inc. | Komórki pomocne w testach do oznaczania aktywności toksyny botulinowej o serotypie a, opartych na immunologii |
AU2015203359A1 (en) * | 2009-03-13 | 2015-07-02 | Allergan, Inc. | Cells useful for immuno-based Botulinum toxin serotype A activity assays |
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