The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Jun. 07, 2011
Filed:
Jul. 20, 2006
Sampathkumar Krishnan, Camarillo, CA (US);
Monica Pallitto, Bellevue, WA (US);
Margaret Ricci, Camarillo, CA (US);
Wenjin Cao, Simi Valley, CA (US);
Hong Lin, Westlake Village, CA (US);
Yong Xie, Thousand Oaks, CA (US);
Samantha Nagle, Dupont, WA (US);
Shon Lee Crampton, Seattle, WA (US);
Sampathkumar Krishnan, Camarillo, CA (US);
Monica Pallitto, Bellevue, WA (US);
Margaret Ricci, Camarillo, CA (US);
Wenjin Cao, Simi Valley, CA (US);
Hong Lin, Westlake Village, CA (US);
Yong Xie, Thousand Oaks, CA (US);
Samantha Nagle, Dupont, WA (US);
Shon Lee Crampton, Seattle, WA (US);
Amgen Inc., Thousand Oaks, CA (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.