Abstract: A multi-dimensional chromatographic method for the separation of N-glycans. The method comprises providing a glycan preparation that includes at least one negatively charged N-glycan. The glycan preparation is then separated by anion-exchange chromatography and at least one secondary chromatographic technique.

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

Abstract: The present invention relates to compositions and methods of engineered IgG Fc constructs, wherein said Fc constructs include one or more Fc domains.

Abstract: Methods of assessing biosimilarity of proteins, e.g., therapeutic antibodies, are described.

Abstract: The present invention features methods of treating a subject having an autoimmune disease and/or inflammation including determining the genotype, and/or the glycophenotype of the subject and administering to the subject an Fc-activity modulating agent or an anti-TNF? agent based on the genotype and/or the glycophenotype of the subject. The invention also features methods of predicting the responsiveness of a patient to an anti-TNF? treatment by identifying a patient having inflammation or an autoimmune disease, determining the genotype, or glycophenotype of the subject, and selecting the patient for treatment with an Fc-activity modulating agent or an anti-TNF? agent based on the genotype and/or the glycophenotype of the subject.

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

Abstract: 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.

Abstract: Methods and compositions related to promoting hair growth are described.

Abstract: Described herein are pharmaceutical compositions comprising a LMWH preparation having at least one chain having a glycol split uronic acid residue (UG) in the preparation and uses thereof.

Abstract: A multi-dimensional chromatographic method for the separation of N-glycans. The method comprises providing a glycan preparation that includes at least one negatively charged N-glycan. The glycan preparation is then separated by anion-exchange chromatography and at least one secondary chromatographic technique.

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

Abstract: Methods and compositions related to high mannose glycans are described.

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

Abstract: The present invention provides methods of evaluating a glycoprotein preparation for the absence, presence or amount of an N-acetylhexosamine glycan, e.g., an N-acetylglucosamine glycan.

Abstract: A method of manufacturing a glatiramer acetate drug product is described. The method entails measuring one or both of alpha helical content of the glatiramer acetate and random coil content of the glatiramer acetate in the batch and manufacturing a glatiramer acetate drug product using at least a portion of the glatiramer acetate when the alpha helical content and or random coil content meets certain criteria.

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

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

Abstract: Modified glycoproteins, and methods of making and using such modified glycoproteins, are described.

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