Relationships among physico-chemical and biological tests for a synthetic Hib-TT conjugate vaccine.
The relationships among physico-chemical and biological tests were evaluated in this study for Cuban Hib vaccine, a tetanus toxoid conjugated with a polysaccharide obtained from chemical synthesis, in order to estimate the biological significance of the relevant physico-chemical assays for lot released. In order to get samples with theoretical different potencies, Hib-TT samples were stored at -20, 4, 25, 37 and 70 degrees C for 5 weeks and after they were evaluated by HPLC and Orcinol methods and for immunogenicity and bactericidal activity. We found strong relationships between HPLC and free PRP level (r2=0.9571), anti-PRP antibodies and bactericidal activity (r2=0.9649) and free PRP content and anti-PRP antibodies titres (r2=0.7671). A lower correlation was found for HPLC and anti-PRP titres (r2=0.5996). We demonstrate that it is possible to monitor this new product combining physico-chemical and biological tests in order to contribute to its characterisation.
Cuervo
Mario Landys Chovel
ML
Cuban Center for Quality Control of Drugs (CECMED), Calle 200, No. 1706 entre 17 y 19, CP 11600, Siboney, Playa, Ciudad de la Habana, Cuba. mariolandys@yahoo.es
Pérez
Lidia Rosa
LR
Oviedo
Maite
M
Costa
Lourdes
L
Perdomo
Vicente
V
D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood; D002851:Chromatography, High Pressure Liquid; D015169:Colony Count, Microbial; D004355:Drug Stability; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology; D019741:Haemophilus influenzae type b / Q000187:drug effects / Q000254:growth & development / Q000276:immunology; D006801:Humans; D007114:Immunization; D007074:Immunoglobulin G / Q000097:blood; D011135:Polysaccharides, Bacterial / Q000276:immunology; D011817:Rabbits; D013048:Specimen Handling / Q000379:methods; D013696:Temperature; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology
D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D007074:Immunoglobulin G; D011135:Polysaccharides, Bacterial; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate