Momenta Pharmaceuticals, Inc.

Xiangping Zhu

Zachary Shriver

Corinne Bauer

Yanjie Jiang

James Eric Anderson

Peter James Ahern

Jonathan C Lansing

Carlos J Bosques

Ganesh Venkataraman

Ian Christopher Parsons

Ganesh Kaundinya

Nathaniel J Washburn

Brian Edward Collins

Rajeev Chillakuru

Dorota A Bulik

Lakshmanan Thiruneelakantapillai

Zachary Schriver

Methods for analyzing, selecting, characterizing or classifying compositions of a co-polymer, e.g., glatiramer acetate are described. The methods entail analysis of pyro-glutamate in the composition, and, in some methods, comparing the amount of pyro-glutamate present in a composition to a reference standard.

Analysis of amino acid copolymer compositions

The presently disclosed subject matter provides methods for evaluating and characterizing peptides, peptide mixtures, and polypeptide mixtures. More particularly, the presently disclosed subject matter provides methods for evaluating or characterizing complex peptide or polypeptide mixtures comprising glutamic acid, alanine, tyrosine, and lysine, e.g., Copolymer-1 or glatiramer acetate, including, but not limited to, methods of identifying, isolating, quantifying, and purifying amino acids, peptides, polypeptides, and combinations thereof having a diethylamide group instead of a carboxyl group present on the C-terminus. The presently disclosed methods can be used to determine the mole percent of polypeptides having a diethylamide group at a C-terminus thereof and can be used to evaluate one or more properties of a sample of one polypeptide mixture as compared to one or more properties of a different sample of a polypeptide mixture.

Methods of evaluating peptide mixtures

Methods of evaluating diethylamide in peptide mixtures for the preparation of glatiramer acetate

Methods of evaluating diethylamide in glatiramer acetate

The present disclosure provides methods for assessing the glycosylation of a target glycoprotein produced by a cell through analysis of cell-surface glycans on the cell. The present disclosure therefore teaches that glycosylation of cell surface proteins can serve as a proxy for glycosylation of other proteins.

Methods related to cell surface glycosylation

Methods for analyzing, selecting, characterizing or classifying compositions of a co-polymer, e.g., glatiramer acetate are described. The methods entail analysis of pyro-glutamate in the composition, and, in some methods, comparing the amount of pyro-glutamate present in a composition to a reference standard. In some cases, the methods entail treating the co-polymer with pyro-glutamate aminopeptidase to cleave N-terminal pyro-glutamate residues.

The present disclosure provides, among other things, methods for the identification of sulfated glycans in a mixture of glycans.

MS methods to evaluate glycans

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North Grafton, MA, United States of America

Xiangping Zhu