RESUMEN
PedvaxHIB is a pediatric vaccine that protects children from severe disease caused by the gram-negative bacterium Haemophilus influenzae type b (Hib). The vaccine is made by chemically conjugating Hib capsular polysaccharide to the outer membrane protein complex of Neisseria meningitidis. The protein-conjugated vaccine has proven to be extremely effective in preventing invasive Hib disease in infants and young children. This paper presents the nuclear magnetic resonance (NMR) methodology for the quantitative characterization of derivatized polysaccharide and its validation closely following ICH guidelines. The assay has been shown to be precise and accurate (relative standard deviation [RSD]Asunto(s)
Proteínas de la Membrana Bacteriana Externa/química
, Vacunas contra Haemophilus/química
, Haemophilus influenzae tipo b/química
, Haemophilus influenzae tipo b/metabolismo
, Polisacáridos Bacterianos/química
, Espectroscopía de Resonancia Magnética
, Estructura Molecular
, Reproducibilidad de los Resultados
, Sensibilidad y Especificidad
, Especificidad por Sustrato
, Vacunas Conjugadas/química