Concentrated protein lyophilates, methods, and uses

Details Concentrated protein lyophilates, methods, and uses Concentrated protein lyophilates, methods, and uses

C - Chemistry, Metallurgy

07

K

C07K 2/00 (2006.01) A61K 9/19 (2006.01) A61K 38/00 (2006.01) A61K 39/395 (2006.01) C07K 16/00 (2006.01) C07K 19/00 (2006.01)

Patent

CA 2612937

The invention provides, among other things, lyophilized compositions of high surface area that comprise a protein and that reconstitute quickly and efficiently to solution of high protein concentration with minimal formation, if any, of foam, effervescence, bubbles, turbidity, or particulates that might be deleterious. The invention also provides, among other things, methods for making the lyophilized compositions. The invention in additional aspects also provides Raman Imaging Spectrographic methods for real time analyses of polymorphs in a sample using PLS algorithms. By way of particular example, the use of the method for the analysis of mannitol polymorphs is described, and the use of the analysis to determine optimum compositions and lyophilization methods for producing lyophilates of pharmaceutical proteins having a predefined distribution of mannitol polymorphs and having the aforementioned reconstitution properties is also described.

L'invention concerne, entre autres, des compositions lyophilisées à surface active étendue renfermant une protéine et se reconstituant rapidement et efficacement en une solution de haute concentration protéique avec une formation minimale, voire nulle, de mousse, d'effervescence, de bulles, de turbidité ou de particules indésirables. L'invention concerne également, entre autres, des procédés de production de ces compositions lyophilisées. Dans des aspects additionnels, l'invention concerne des procédés spectrographiques d'imagerie Raman destinés à l'analyse en temps réel de polymorphes dans un échantillon au moyen d'algorithmes PLS. A travers un exemple particulier, on décrit l'utilisation du procédé pour l'analyse de polymorphes de mannitol ainsi que l'utilisation de cette analyse pour déterminer des compositions et des procédés de lyophilisation optimaux pour produire des lyophilisats de protéines pharmaceutiques présentant une distribution prédéfinie de polymorphes de mannitol et présentant les propriétés de reconstitution susmentionnées.

Affiliated with

Also associated with

Rating

Concentrated protein lyophilates, methods, and uses does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Concentrated protein lyophilates, methods, and uses, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Concentrated protein lyophilates, methods, and uses will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFCA-PAI-O-1715773