A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 47/16 (2006.01) A61K 39/395 (2006.01) G01N 33/50 (2006.01)
Patent
CA 2742791
The invention provides compositions and methods for inhibiting fractionation of immunoglobulins comprising a lambda light chain based on the observation that iron, in the presence of histidine, results in increased fragmentation of a recombinant fully human IgG molecule containing a lambda light chain due to cleavage in the hinge region The invention further provides an aqueous pharmaceutical formulation comprising an antibody, or antigen-binding portion thereof, that binds the p40 subunit of IL-12/IL-23 and a buffer system comprising histidine, wherein the formulation has enhanced stability, including enhanced resistance to fragmentation
La présente invention concerne des compositions et des procédés pour inhiber le fractionnement dimmunoglobulines comprenant une chaîne légère lambda basés sur lobservation que le fer, en présence dhistidine, induit une fragmentation renforcée dune molécule IgG totalement humaine recombinante contenant une chaîne légère lambda due au clivage dans la région de charnière. Linvention concerne en outre une formulation pharmaceutique aqueuse comprenant un anticorps, ou une portion de liaison dantigène de celui-ci, qui se lie à la sous-unité p40 dIL-12/IL-23 et un système tampon comprenant de lhistidine, où la formulation a une stabilité augmentée, comprenant une résistance augmentée à la fragmentation.
Correia Ivan R.
Fraunhofer Wolfgang
Kantor Angela
Radziejewski Czeslaw H.
Warne Nicholas W.
Abbott Laboratories
Torys Llp
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