Concentrated protein lyophilates, methods, and uses

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

2011-06-07

2011-06-07

Saunders, David A (Department: 1644)

Chemistry: natural resins or derivatives; peptides or proteins;

Proteins, i.e., more than 100 amino acid residues

C424S130100, C424S133100, C424S134100, C424S499000, C514S001100, C514S777000, C530S387100, C530S387300

Reexamination Certificate

active

07956160

ABSTRACT:
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.

REFERENCES:
patent: 6180355 (2001-01-01), Alexander
patent: 6284282 (2001-09-01), Maa et al.
patent: 6821515 (2004-11-01), Cleland et al.
patent: 2002/0136719 (2002-09-01), Shenoy et al.
patent: 2003/0026813 (2003-02-01), Gallili et al.
patent: 2004/0219224 (2004-11-01), Yakovlevsky et al.
patent: 2005/0220786 (2005-10-01), Mahler
patent: 2007/0196364 (2007-08-01), Krishnamurthy et al.
patent: 2008/0213215 (2008-09-01), Krishnan et al.
patent: WO 03/053465 (2003-07-01), None
patent: WO 2006/014965 (2006-02-01), None
patent: WO 2006/042240 (2006-04-01), None
patent: WO 2006/138181 (2006-12-01), None
patent: WO 2007/005612 (2007-01-01), None
Hawe et al, Europ. Jour. Pharma. Sci., 28, 224-232, 2006.
Johnson et al, Jour. Pharma. Sci., 91, 914-922, 2002.
Pyne et al, Jour. Pharma. Sci., 92, 2272-2283, 2003.
Economides, A.N., et al., “Cytokine traps: multi-component high-affinity blockers of cytokine action”, Nature Medicine, Jan. 2003, vol. 9, No. 1, pp. 47-52.

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: LFUS-PAI-O-2676611