title: Global perspective on specifications for biotechnology products--perspective from Japan.
authors.affiliation: Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Hayakawa
mesh_terms: D001702:Biopharmaceutics / Q000592:standards*; D001709:Biotechnology / Q000592:standards*; D017277:Drug Approval; D004340:Drug Contamination; D015195:Drug Design; D004341:Drug Evaluation / Q000592:standards; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D006023:Glycoproteins / Q000737:chemistry / Q000302:isolation & purification / Q000592:standards; D007391:International Cooperation; D007564:Japan; D007880:Legislation, Drug; D015394:Molecular Structure; D009844:Oligosaccharides / Q000032:analysis; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D011994:Recombinant Proteins / Q000737:chemistry / Q000302:isolation & purification / Q000592:standards*
chemical_list: D006023:Glycoproteins; D009844:Oligosaccharides; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins