CONCENTRATED PROTEIN LYOPHILATES, METHODS, AND USES

CONCENTRATED PROTEIN LYOPHILATES, METHODS, AND USES
Publication Number: WO/2007/014073 International Application No.: PCT/US2006/028476
Publication Date: 01.02.2007 International Filing Date: 20.07.2006

Int. Class.: A61K 38/17 (2006.01)
Applicants: AMGEN INC. [US/US]; Mail Stop 28-2-C, One Amgen Center Drive, Thousand Oaks, California 91320-1799 (US) (All Except US).
KRISHNAN, Sampathkumar [IN/US]; 2093 Paseo Girasol, Camarillo, California 93012 (US) (US Only).
PALLITTO, Monica [US/US]; 709 Dearborn Avenue, Newbury Park, California 91320 (US) (US Only).
NAGLE, Samantha [US/US]; 1341 N. Crescent Heights, 204, West Hollywood, California 90046 (US) (US Only).
CRAMPTON, Shon Lee [US/US]; 1710 North Fuller Avenue, #304, Los Angeles, California 98136 (US) (US Only).
RICCI, Margaret Speed [US/US]; 1394 La Culebra Circle, Camarillo, California 93012 (US) (US Only).
CAO, Wenjin [US/US]; 290 Rustling Heights Court, Simi Valley, California 93065 (US) (US Only).
LIN, Hong [CN/US]; 761 Via Colinas, Westlake Village, California 91362 (US) (US Only).
XIE, Yong [CN/US]; 418 E. Wilbur Road, Apt. 207, Thousand Oaks, California 91360 (US) (US Only).
Inventors: KRISHNAN, Sampathkumar [IN/US]; 2093 Paseo Girasol, Camarillo, California 93012 (US).
PALLITTO, Monica [US/US]; 709 Dearborn Avenue, Newbury Park, California 91320 (US).
NAGLE, Samantha [US/US]; 1341 N. Crescent Heights, 204, West Hollywood, California 90046 (US).
CRAMPTON, Shon Lee [US/US]; 1710 North Fuller Avenue, #304, Los Angeles, California 98136 (US).
RICCI, Margaret Speed [US/US]; 1394 La Culebra Circle, Camarillo, California 93012 (US).
CAO, Wenjin [US/US]; 290 Rustling Heights Court, Simi Valley, California 93065 (US).
LIN, Hong [CN/US]; 761 Via Colinas, Westlake Village, California 91362 (US).
XIE, Yong [CN/US]; 418 E. Wilbur Road, Apt. 207, Thousand Oaks, California 91360 (US).
Agent: REINECKE, Raz; AMGEN INC., One Amgen Center Drive, Mail Stop 28-2-c, Thousand Oaks, California 91320-1799 (US).
Priority Data: 60/702,025 22.07.2005 US
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.
Comments: 0
Votes:5