Stabilized antibody formulations and uses thereof

A - Human Necessities – 61 – K

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Details

A61K 39/395 (2006.01) A61P 29/00 (2006.01) A61P 37/00 (2006.01) C07K 16/24 (2006.01)

Patent

CA 2663892

The present invention provides methods of optimizing certain stable liquid formulations of antibodies that immunospecifically bind to antigens of interest. Such formulations are suitable for parenteral administration to a subject, and exhibit increased stability, low to undetectable levels of aggregation, low to undetectable levels of antibody fragmentation/degradation, and very little to no loss of the biological activities of the antibodies, even during long periods of storage. The methods of the invention provide formulations that offer multiple advantages over formulations produced by non-optimized methods, including less stringent or more readily available transportation and storage conditions, less frequent dosing, and/or smaller dosage amounts in the therapeutic, prophylactic and diagnostic uses of such formulations. The invention further provides methods of identifying antibodies exhibiting certain phase behaviors such that the antibodies can be formulated by the methods of the invention. Also provided are prophylactic, therapeutic, and diagnostic uses of such antibody formulations.

La présente invention concerne des procédés permettant d'optimiser certaines formulations liquides stables d'anticorps se liant de manière immunospécifique à des antigènes d'intérêt. De telles formulations sont appropriées pour une administration parentérale à un sujet et présentent une stabilité accrue, des niveaux d'agrégation faibles voire indécelables, des niveaux de fragmentation/de dégradation d'anticorps faibles voire indécelables et très peu ou pas de perte des activités biologiques des anticorps, même pendant de longues périodes de stockage. Les procédés de l'invention fournissent des formulations qui offrent de multiples avantages par rapport aux formulations produites par des procédés non optimisés : conditions de stockage et de transport disponibles plus rapidement ou moins strictes ; dosages moins fréquent, et/ou quantités de dosage inférieures lors d'utilisations thérapeutique, prophylactique et diagnostique de telles formulations. L'invention fournit, en outre, des procédés d'identification d'anticorps présentant certains comportements de phase, de sorte que les anticorps peuvent être formulés par les procédés de l'invention. L'invention fournit également les utilisations prophylactiques, thérapeutiques et diagnostiques de telles formulations d'anticorps.

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