Immuno-based botulinum toxin serotype a activity assays

Abstract

The present specification discloses SNAP-25 compositions, methods of making α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P 1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P 1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, methods of detecting BoNT/A activity, and methods of detecting neutralizing α-BoNT/A antibodies.

What is claimed is: 
     
         1 . An isolated α-SNAP-25 antibody, wherein the isolated α-SNAP-25 antibody specifically binds to the peptide of SEQ ID NO:38, and wherein the isolated α-SNAP-25 antibody comprises a heavy chain variable region comprising complementary determining regions (CDRs) comprising the amino acid sequences of at least one of SEQ ID NOs: 93, 96, and 100 and a light chain variable region comprising CDRs comprising the amino acid sequences of at least one of SEQ ID NOs: 105, 110 and 115; or a heavy chain variable region comprising complementary determining regions (CDRs) comprising the amino acid sequences of at least one of SEQ ID NOs: 95, 99, and 101 and a light chain variable region comprising CDRs comprising the amino acid sequences of at least one of SEQ ID NOs: 103, 108 and 113. 
     
     
         2 . The isolated α-SNAP-25 antibody of  claim 1 , comprising a heavy chain variable region comprising CDRs comprising the amino acid sequences of SEQ ID NO: 95 (CDR1), SEQ ID NO: 99 (CDR2), and SEQ ID NO: 101 (CDR3) and a light chain variable region comprising CDRs comprising the amino acid sequences of SEQ ID NO: 103 (CDR1), SEQ ID NO: 108 (CDR2), and SEQ ID NO: 113 (CDR3).