Antibody formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 39/395 (2006.01) A61P 35/00 (2006.01) A61P 37/00 (2006.01)

Patent

CA 2692681

This invention relates to a shear and temperature stable antibody formulations that are more stable than compared to a standard formulation (such as 30 mM citrate, 10OmM NaCl, pH 6.5). The present invention's shear and temperature stable antibody formulations show reduced precipitation when subjected to stress conditions but the standard formulation had aggregated. This result was unpredictable because thermodynamically the two formulations are similar as seen by their DSC (differential scanning calorimeter) profiles.

L'invention concerne des formulations d'anticorps stables au cisaillement et à la température, qui sont plus stables qu'une formulation type (telle que citrate à 30 mM, NaCl à 100 mM, pH 6,5). Les formulations d'anticorps stables au cisaillement et à la température de la présente invention affichent une précipitation réduite lorsqu'elles sont soumises à des conditions de contrainte, contrairement à la formulation type qui s'agrège. Ce résultat était imprévisible du fait que les deux formulations sont thermodynamiquement similaires, comme qu'observé par leurs profils DSC (calorimètre à balayage différentiel).

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