Abstract: Preparations of glycoproteins, e.g., therapeutic preparations of glycoproteins, having altered levels of affinity for Fc? receptors relative to reference glycoprotein preparations, and methods of making and methods of using such preparations, are described.

Abstract: The present invention relates to the characterization and production of denosumab.

Abstract: Among other things, the present disclosure provides methods for enriching, identifying, and/or quantifying unusually modified glycans (e.g., phosphorylated glycans, sulfated glycans, and/or multi-acetylated glycans). In many embodiments, methods comprise providing a glycan preparation from which sialic acids have been released; subjecting the sialidase-treated glycan preparation to a separation technique that separates glycans based on charge-to-mass ratio; and quantifying the charged products using at least one quantification standard.

Abstract: Glatiramer acetate containing compositions and drug products can be manufactured using methods that include a step of measuring one or both of the alpha helical content of the glatiramer acetate and the random coil content of the glatiramer acetate. These measurements can be compared to particular values or ranges for one or both of alpha helical and random coil content. The results of the comparison can be used in determining whether a given batch of glatiramer acetate should be used to manufacture a glatiramer acetate-containing drug product. The measurement of alpha helical content of the glatiramer acetate and the random coil content can be carried out using various methods, including circular dichroism.

Abstract: Glycoproteins having particular sialylation patterns, and methods of making and using such glycoproteins, are described.

Abstract: Methods of making and evaluating antibody biological therapeutics (biosimilars) for adalimumab, rituximab and panitumumab are disclosed.

Abstract: 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.

Abstract: Methods of evaluating heparin preparations, e.g., for suitability for use as a drug or for use in making a drug, by determining the absence, presence or amount of a structural signature, wherein, e.g., the structural signature is indicative of the methods used to make the heparin preparation.

Abstract: The present invention relates to the characterization and production of omalizumab.

Abstract: The present disclosure provides methods for analyzing structure and/or composition of N-glycans. Such methods often involve digestion of N-glycans with multiple exoglycosidases. In some embodiments, N-glycans are digested with multiple exoglycosidases simultaneously. In some embodiments, N-glycans are digested with multiple exoglycosidases sequentially. In some embodiments, methods in accordance with the present disclosure involve comparison of cleavage products of N-glycans that have been digested with multiple exoglycosidases simultaneously to N-glycans that have been digested with multiple exoglycosidases sequentially.

Abstract: The present invention relates to the characterization and production of alemtuzumab.

Abstract: Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using DMSO, are described.

Abstract: 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.

Abstract: 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.

Abstract: Methods of making copolymers are described.

Abstract: Polypeptides having target levels of C-terminal variants are described.

Abstract: Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using copper, are described.

Abstract: Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using DMSO, are described.

Abstract: Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using ammonium and/or lysine, are described.

Abstract: Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using putrescine, are described.