title: Procurement of reference materials against recombinant HBsAg surface antigen.
abstract: Mabs against HBsAg have been used for structural analyses, development of diagnostic tests, and for antigen immunopurification. Resultant products obtained from current methods of genetic recombination demand reference materials to test their potency, identity, purity, and the biological and immunological specific activity corresponding to their manufacturing processes. In this paper, we present a method for the qualitative and quantitative characterisation of CB.Hep-1 and CB.Hep-4 RM and their stability, in real time, with the required quality to be used as primary reference materials. Among the criteria applied in this study, we considered Mab-specific concentration through ELISA, purity, and total proteins by various methods, quantification of antigen recognition capacity of Mabs through the Ag-Mab absolute-recognition method. Sterility, homogeneity, stability, subclass, and isoelectric focusing were used in the characterisation of the reference materials.
authors.affiliation: Process Control Division, Centre for Genetic Engineering and Biotechnology, Havana, Cuba.
authors.forename: Maria del Carmen
authors.initials: Mdel C
authors.lastname: Abrahantes
authors.forename: Biunayki
authors.initials: B
authors.lastname: Reyes
authors.forename: Jesus
authors.initials: J
authors.lastname: Reyes
authors.forename: Raudel
authors.initials: R
authors.lastname: Sosa
authors.forename: Ernesto M
authors.initials: EM
authors.lastname: González
authors.forename: Maribel
authors.initials: M
authors.lastname: Vega
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Valdés
authors.forename: Eduardo
authors.initials: E
authors.lastname: Martínez
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000096:biosynthesis / Q000276:immunology / Q000302:isolation & purification; D001202:Ascitic Fluid / Q000276:immunology; D002846:Chromatography, Affinity; D002850:Chromatography, Gel; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D006510:Hepatitis B Antibodies / Q000096:biosynthesis / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000032:analysis* / Q000276:immunology / Q000302:isolation & purification; D007074:Immunoglobulin G / Q000276:immunology*; D007132:Immunoglobulin Isotypes / Q000032:analysis / Q000276:immunology; D007525:Isoelectric Focusing; D016014:Linear Models; D051379:Mice; D008807:Mice, Inbred BALB C; D011994:Recombinant Proteins / Q000032:analysis / Q000276:immunology / Q000302:isolation & purification; D012015:Reference Standards; D012756:Sheep
chemical_list: D000911:Antibodies, Monoclonal; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D007074:Immunoglobulin G; D007132:Immunoglobulin Isotypes; D011994:Recombinant Proteins