Antibody formulations having optimized aggregation and...

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 16/10 (2006.01)

Patent

CA 2613512

The present invention provides methods of optimizing the production and purification of antibody formulations that immunospecifically bind to antigens of interest and are suitable for parenteral administration to a subject, which formulations exhibit increased stability due to reduced degradation and aggregation of the antibody component on long term storage. Such methods provide formulations that offer multiple advantages over formulations produced by non-optimized methods including less stringent or more readily available transportation/storage conditions, and less frequent dosing or smaller dosage amounts in the therapeutic, prophylactic and diagnostic use of such formulations. The invention further provides methods of utilizing the formulations of the present invention.

L'invention concerne des procédés d'optimisation de la production et de la purification de formulation d'anticorps qui se lient de façon immunospécifique à des antigènes d'intérêt et qui conviennent à l'administration parentérale d'un sujet, ces formulations présentant une stabilité accrue du fait de la dégradation et de l'agrégation réduite du composant d'anticorps lors du stockage à long terme. Ces procédés fournissent des formulations qui offrent des avantages multiples sur des formulations produites par des procédés non optimisés possédant des conditions de stockage/transport disponibles plus rapidement ou moins stricts, et des dosages moins fréquents ou des quantités de dosage inférieures dans l'usage thérapeutique, prophylactique et diagnostique de ces formulations. L'invention concerne enfin des procédés d'utilisation de ces formulations.

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