title: Analytical platform for glycomic characterization of recombinant erythropoietin biotherapeutics and biosimilars by MS.
abstract: BACKGROUND
  Erythropoietin is a therapeutic glycoprotein that stimulates red blood cell production. The quality, safety and potency of recombinant erythropoietins are determined largely by their glycosylation. Small variations in cell culture conditions can significantly affect the glycosylation, and therefore the efficacy, of recombinant erythropoietins. Thus, detailed glycomic analyses are necessary to assess biotherapeutic quality. We have developed a platform for qualitative and quantitative glycomic analysis of recombinant erythropoietins.
  
  
  RESULTS
  The platform was used to profile native N-glycans from three production batches of darbepoetin alfa (also known as NESP), a common form of recombinant erythropoietin. Darbepoetin alfa was found to contain an abundance of large, multi-antennary N-glycans with high levels of sialylation, O-acetylation and dehydration. Results were verified by independent orthogonal analysis with both MALDI-TOF and nano-LC/Q-TOF MS.
  
  
  CONCLUSIONS
  This platform may be applied to QC and batch analysis of not only recombinant erythropoietin, but also other complex, glycosylated biotherapeutics and biosimilars.
authors: Graduate School of Analytical Science & Technology, Chungnam National University, Daejeon, Korea.
authors: Myung Jin
authors: MJ
authors: Oh
authors: Serenus
authors: S
authors: Hua
authors: Bum Jin
authors: BJ
authors: Kim
authors: Ha Neul
authors: HN
authors: Jeong
authors: Seung Hyup
authors: SH
authors: Jeong
authors: Rudolf
authors: R
authors: Grimm
authors: Jong Shin
authors: JS
authors: Yoo
authors: Hyun Joo
authors: HJ
authors: An
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000032:analysis* / Q000592:standards; D002236:Carbohydrate Conformation; D004921:Erythropoietin / Q000032:analysis* / Q000235:genetics / Q000592:standards; D006031:Glycosylation; D006801:Humans; D007536:Isomerism; D036103:Nanotechnology; D009438:Neuraminic Acids / Q000032:analysis; D043524:Peptide-N4-(N-acetyl-beta-glucosaminyl) Asparagine Amidase / Q000378:metabolism; D011134:Polysaccharides / Q000737:chemistry* / Q000302:isolation & purification / Q000592:standards; D011786:Quality Control; D011994:Recombinant Proteins / Q000032:analysis / Q000096:biosynthesis / Q000592:standards; D052616:Solid Phase Extraction; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization / Q000592:standards
chemical_list: D059451:Biosimilar Pharmaceuticals; D009438:Neuraminic Acids; D011134:Polysaccharides; D011994:Recombinant Proteins; D004921:Erythropoietin; D043524:Peptide-N4-(N-acetyl-beta-glucosaminyl) Asparagine Amidase