Self-buffering protein formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 39/395 (2006.01) C12P 21/08 (2006.01)

Patent

CA 2610839

The invention herein described, provides, among other things, self-buffering protein formulations. Particularly, the invention provides self-buffering pharmaceutical protein formulations that are suitable for veterinary and human medical use. The self-buffering protein formulations are substantially free of other buffering agents, stably maintain pH for the extended time periods involved in the distribution and storage of pharmaceutical proteins for veterinary and human medical use. The invention further provides methods for designing, making, and using the formulation. In addition to other advantages, the formulations avoid the disadvantages associated with the buffering agents conventionally used in current formulations of proteins for pharmaceutical use. The invention in these and other respects can be productively applied to a wide variety of proteins and is particularly useful for making and using self-buffering formulations of pharmaceutical proteins for veterinary and medical use, especially, in particular, for the treatment of diseases in human subjects.

L'invention concerne, entre autres, des préparations de protéines à tamponnage spontané. L'invention concerne en particulier des préparations de protéines pharmaceutiques à tamponnage spontané qui sont appropriées pour un usage en médecine vétérinaire et humaine. Les préparations de protéines à tamponnage spontané sont sensiblement dépourvues d'autres tampons, maintiennent de manière stable le pH pour des durées prolongées impliquées dans la distribution et le stockage de protéines pharmaceutiques à usage en médecine vétérinaire et humaine. L'invention concerne également des méthodes de conception, de production et d'utilisation de la préparation. En plus d'autres avantages, les préparations évitent les désavantages associés aux tampons traditionnellement utilisés dans les préparations courantes de protéines à usage pharmaceutique. L'invention peut être appliquée de manière productive à une large variété de protéines et est particulièrement utile pour la production et l'utilisation de préparations à tamponnage spontané de protéines pharmaceutiques à usage vétérinaire et médical, notamment, en particulier, pour le traitement de maladies chez des sujets humains.

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