Haemophilus Vaccines/immunology; Quality Control; Technology Transfer; Technology, Pharmaceutical/methods; Animals; Enzyme-Linked Immunosorbent Assay/methods; Haemophilus Infections/microbiology; Haemophilus Infections/prevention & control; Haemophilus Vaccines/administration & dosage; Haemophilus Vaccines/isolation & purification; Haemophilus influenzae type b/immunology; Mice; T-Lymphocytes/immunology; Vaccines, Conjugate/administration & dosage; Vaccines, Conjugate/immunology; Vaccines, Conjugate/isolation & purification

ADH, adipic acid dihydrazide; BSA, bovine serum albumin; ELISA; ELISA, enzyme-linked immuno sorbent assay; EP, European Pharmacopeia; HPSEC, high performance size exclusion chromatography; Haemophilus Influenzae type b vaccine; Hib, Haemophilus Influenzae type b; IPC, in process control; IgG, immunoglobulin G; Intravacc, Institute for Translational Vaccinology; Mn, number-average molecular weight; Mr, molecular weight; Mw, weight-average molecular weight; NIBSC, National Institute for Biological Standards and Control (UK); NIH, National Institutes of Health; NMR, nuclear magnetic resonance; NVI, Netherlands Vaccine Institute; PBS, phosphate buffered saline; PRP; PRP, poly-ribosylribitol phosphate (Hib capsular polysaccharide); PRP-T, Hib vaccine (PRP conjugated to tetanus toxoid); QC, quality control; RI, refractive index; RIVM, The National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu); TMB, tetramethyl benzidine; TTd, tetanus toxoid; UV, ultraviolet; WHO, World Health Organization; antigenicity; characterization; conjugate; cultivation; immunogenicity; kDa, kilo dalton; polysaccharide; purification; tR, retention time