Momenta Pharmaceuticals, Inc.

Xiao-Jin Xu

Cuihua Liu

Shiming Dong

Jonathan C Lansing

Yanjie Jiang

Carlos J Bosques

Nathaniel J Washburn

Jennifer Murphy

Hetal Sarvaiya

Guy Dellorusso

Nathaniel Washburn

Carlos Bosques

Methods of producing recombinant therapeutic fusion proteins described herein can include culturing Chinese hamster ovary (CHO) cells under conditions suitable for expression of a recombinant therapeutic fusion protein including one or more glycans, where the CHO cells have not been genetically engineered to produce terminal alpha-galactosyl residues on glycans; treating the one or more glycans of the recombinant glycoprotein with one or more exoglycosidases; measuring glycans containing terminal galactose-alpha-1-3-galactose residues on the fusion protein by nuclear magnetic resonance (NMR); and producing a recombinant therapeutic fusion protein in the CHO cells if a target level of terminal galactose-alpha-1-3-galactose residues is measured.

Galactose-alpha-1, 3-galactose-containing n-glycans in glycoprotein products derived from CHO cells

Methods of analyzing glatiramer acetate (GA) or a polymeric precursor thereof are provided. The methods can include determining a level of one or more diethylamide-modified amino acids in a sample comprising GA or a polymeric precursor thereof, and selecting at least a portion of the sample based on the assessment of the one or more diethylamide-modified amino acids in the sample.

Evaluation of copolymer diethylamide

The present disclosure provides methods for analyzing structure and/or composition of glycoproteins and glycans of glycoproteins. Such methods can include subjecting a glycoprotein preparation to a condition that removes at least one O-linked glycan from the glycoprotein. Such methods can include subjecting a glycoprotein preparation to a condition that releases an N-glycan from the glycoprotein, e.g., prior to subjecting the glycoprotein to a condition that releases an O-glycan from the glycoprotein.

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The present invention provides methods of evaluating CHO cells.

Gal &#x3b1;1-3gal-containing N-glycans in glycoprotein products derived from CHO cells

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Jamaica Plain, MA, United States of America

Xiao-Jin Xu