Comparison between in vitro potency tests for Cuban hepatitis B vaccine: contribution to the standardization process.
Quality control of recombinant Hepatitis B vaccines performed by National Control Laboratories prior to marketing vaccine batches requires in vivo and or a well validated in vitro potency assays as recommended by WHO technical series. The in vitro test must also demonstrate its suitability for monitoring the consistency of the vaccine manufacturer. The aim of this study was to establish the relationship between both in vitro potency tests performed by Cuban manufacturer and National Control Laboratory for Hepatitis B vaccine and the suitability of our method for monitoring the manufacturer's test results and consistency. We also intended to contribute to the standardisation process consisting of in vitro methods for this vaccine.
Cuervo
Mario Landys Chovel
ML
Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED), Calle 200, No 1706 entre 17 y 19, CP 11600, Siboney, Playa, Ciudad de la Habana, Cuba. lc@ipk.sld.cu
de Castro Yanes
Ania Fernández
AF
D003462:Cuba; D006509:Hepatitis B / Q000276:immunology* / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000276:immunology* / Q000592:standards*; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D014944:World Health Organization
D017325:Hepatitis B Vaccines