Stability testing of antibodies

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 16/06 (2006.01) G01N 33/68 (2006.01)

Patent

CA 2709029

Antibodies are biological macromolecules which may be subject to modification and degradation processes. A new LC/MS-based method for separating and characterizing antibody-specific degradation products is described in the present application which comprises an enzymatic digestion step to cleave the heavy chain using the enzyme IdeS.

Les anticorps sont des macromolécules biologiques qui peuvent être sujettes à des processus de modification et de dégradation. La présente invention concerne un nouveau procédé à base de chromatographie en phase liquide et de spectrométrie de masse (LC/MS) permettant de séparer et de caractériser les produits de dégradation spécifiques d'un anticorps, ledit procédé comprenant une étape de digestion enzymatique pour couper la chaîne lourde à l'aide de l'enzyme IdeS.

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