Amgen Inc.

Shon Lee Crampton

Timothy David Osslund

Christi L Clogston

Margaret Ricci

Randal B Bass

Sampathkumar Krishnan

Monica Pallitto

Wenjin Cao

Hong Lin

Yong Xie

Samantha Nagle

Margaret Speed Ricci

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.

Concentrated protein lyophilates, methods, and uses

The present invention relates to crystalline etanercept and to methods of making crystalline etanercept; to pharmaceutical compositions comprising crystalline etanercept; and to therapeutic uses of such compositions.

Crystals of etanercept and methods of making thereof

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Seattle, WA, United States of America

Shon Lee Crampton