Amgen Inc.

Margaret Ricci

Pavel V Bondarenko

Douglas Rehder

Thomas M Dillon

Yuefeng Lu

Joe Zhou

Yuling Zhang

Shon Lee Crampton

Douglas D Banks

Gerd Kleemann

Gary Pipes

Andrew Goetze

Himanshu S Gadgil

Samantha Nagle

Yong Xie

Hong Lin

Wenjin Cao

Monica Pallitto

Sampathkumar Krishnan

Thomas Dillon

Douglas Banks

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 is generally directed to methods of producing an increase in the enrichment or recovery of preferred forms of IgG proteins. More particularly, the invention relates to subjecting preparations of such recombinant IgG proteins with a reduction/oxidation coupling reagent and optionally a chaotropic agent.

Methods for refolding of recombinant antibodies

The present invention is directed to a novel method of analysis of high molecular weight proteins. More specifically, it is directed to a novel reversed-phase LC/MS method of analysis of high molecular weight proteins including antibodies.

LC/MS method of analyzing high molecular weight proteins

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Camarillo, CA, United States of America

Margaret Ricci