Patent ID: 8114832
Filing Date: 2012-02-14
Classification: G01N

Abstract:
1. A method for determining that a protein with cross-beta structure was introduced to a pharmaceutical composition and/or any constituent of the pharmaceutical composition during the manufacture and/or storage of the pharmaceutical composition and/or any constituent of the pharmaceutical composition, said method comprising: contacting said pharmaceutical composition and/or said constituent of the pharmaceutical composition with at least one cross-beta structure-binding compound, wherein the at least one cross-beta structure-binding compound is selected from the group consisting of: 2-(4′-(methylamino)phenyl)-6-methylbenzothiaziole, Thioflavin S, Polythiophene acetic acid, Thiophene acetic acid, Chrysamine G, a styryl dye, conjugated polyelectrolyte lithium salt of poly(thiophene-3 acetic acid) (PTAA-Li), glycosaminoglycans, BTA-1, Tissue-type plasminogen activator, Factor XII, Fibronectin, a hepatocyte growth factor activator, Serum amyloid P component, Clq, CD36, Receptor for advanced glycation end-products, Scavenger receptor-A, Scavenger receptor-B, Calreticulin, Hybridoma conformational antibody WO1, formyl peptide receptor-like 1, Aβ-purified Rabbit anti-albumin-AGE antibody, apoJ/clusterin, a Finger domain of tPA, factor XII, fibronectin, Plasmin, Plasminogen, 75kD-neurotrophin receptor (p75NTR), α2-macroglobulin, High molecular weight kininogen, Cathepsin K, Matrix metalloprotease 9, Haem oxygenase-1, low-density lipoprotein receptor-related protein (LRP), vascular endothelial growth factor 165 (VEGF165), Hybridoma conformational antibody WO2, α(6)β(1)-integrin, CD40/CD40-ligand, tissue-type plasminogen activator (tPA) in complex with D-Phenylalanyl-L-prolyl-L-arginine chloromethyl ketone (PPACK), and epsilon-amino caproic acid (εACA), Apolipoprotein E, Matrix metalloprotease-1, Matrix metalloprotease-2, Matrix metalloprotease-3, Amyloid oligomer-specific antibody, CD47, apolipoprotein A-I (Apo A-I) belonging to small high-density lipoproteins, FEEL-1, lectin-like oxidized low-density lipoprotein receptor 1 (LOX-1), lymphocyte antigen 96 (MD2), fasciclin EGF-like laminin-type EGF-like and link domain-containing scavenger receptor-2 (FEEL-2), macrophage receptor with collagenous structure (MARCO), C reactive protein, Lysozyme, Tamm-Horsfall protein, CD11b2, Pentraxin-3, Serum amyloid A proteins, Stabilin-1, Stabilin-2, LPS-binding protein, CD45, alpha-1 antitrypsin, Alpha-1 acid glycoprotein, lactoferrin, Complement receptor CD11b/CD18 (Mac-1, CR3), CD11a/CD18 (LFA-1, subunit aL), CD36, LIMPII analogous-I (CLA-1), CD14, orosomucoid, apo A-IV-TTR complex, β2-glycoprotein I, megalin, Apolipoprotein E4, CD11d/CD18 (subunit aD), integrin aX subunit (CD11c), and Von Willebrand factor; and detecting if a protein with cross-beta structure of said pharmaceutical composition and/or said constituent of the pharmaceutical composition is bound to said cross-beta structure-binding compound, wherein detected binding of said protein with cross-beta structure to said cross-beta structure-binding compound indicates that the protein with cross-beta structure is present in the pharmaceutical composition and/or any constituent of the pharmaceutical composition, and wherein presence of the protein with cross-beta structure in the pharmaceutical composition and/or any constituent of the pharmaceutical composition indicates that the protein with cross-beta structure was introduced to the pharmaceutical composition and/or any constituent of the pharmaceutical composition during the manufacture and/or storage of the pharmaceutical composition and/or any constituent of the pharmaceutical composition.