Glyco Thera GmbH, Hannover (HRB 9000)

validation upstream therapeutic testing support sulfation state-of-the-art stability sialylation sialic acid service safety release recombinant protein primary structure posttranslational phosphorylation oxidation oligosaccharide oligomannosidic monoclonal modification method development mass spectrometry mab glycation glycan expertise electrospray efficacy downstream disulfide deamidation comparability characterization cIEF biosimilar antibody antennarity analytical acylation Xgeva Trastuzumab Synagis Simponi SEC Rituximab Rituxan Regulatory authorities Quality Prolia Palivizumab O-glycan Neu5Gc Neu5Ac N-glycan Marketing authorization application MabThera MAA Lot-to-lot consistency IgG IEX Humira Herceptin HPLC HPAEC-PAD Golimumab Glycosylation Glycoprotein GMP FSH FDA Etanercept Erythropoietin Enbrel EPO EMA Dossier Denosumab Control Coagulation factor CEX Bevacizumab Avastin Adalimumab 2-AB