Momenta Pharmaceuticals, Inc.

Corinne Bauer

Zachary Shriver

Xiangping Zhu

Yanjie Jiang

James Eric Anderson

Peter James Ahern

Jonathan C Lansing

Ganesh Venkataraman

Ganesh Kaundinya

Nur Sibel Gunay

Ishan Capila

Mallikarjun Sundaram

Daniela Beccati

Yiwei Qi

Cuihua Liu

Yiming Yao

Zainab Sirajbhai Mamuwala

Ian David Fier

Ying Li

Xianping Zhu

Pat Oliver-Shaffer

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

Preparations of low molecular weight heparins (LMWHs) having improved properties, e.g., properties that provide a clinical advantage, are provided herein. Methods of making and using such preparations as well as methods of analyzing starting materials, processing, intermediates and final products in the production of such LMWH preparations are provided.

Low molecular weight heparin composition and uses thereof

Methods of evaluating diethylamide in glatiramer acetate

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.

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Sudbury, MA, United States of America

Corinne Bauer