الفهرس يوجد فقط 14 صفحة متاحة للعرض العام
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المستخلص
Quality control of vaccines is crucial to ensure their quality, safety and efficacy. In this study, a sandwich-type enzyme linked immunosorbent assay (ELISA) was optimized and validated to determine the in-vitro relative potency of the quadrivalent prophylactic human papillomavirus (HPV) vaccine. A modification of the desorption step required to release the VLPs from the aluminum adjuvant was carried out. Then a novel stability-and potency-indicating assay protocol for the determination of the vaccine was developed. Vacuum-driven immunoaffinity extraction (IAE) was employed using type-specific, conformation-dependent antibodies against each type of HPV VLPs. Antigen content was then determined using size exclusion high performance liquid chromatography (SE-HPLC) over a concentration range of 5.00-20.00 æg/mL for the four HPV types. The SE-HPLC assay was found accurate and precise (RSD<10.00%). The assay protocol was found superior to conventional ELISA with respect to total analysis time. Good correlation between the results of analysis obtained using IAE-SE-HPLC and ELISA was demonstarted. Stability of the quadrivalent HPV vaccine was also evaluated. The vaccine was found stable to temperature up to 50{uF0B0}C and unstable to pH changes and repeated freeze/thaw cycles. Optimization of downstream purification and analysis of recombinant human myelin basic protein (rhMBP) expressed in the milk of transgenic cows was also investigated