RESUMEN
BACKGROUND AND OBJECTIVES: Intravenous immunoglobulin G (IVIG) preparations are used in several disorders: primary and secondary immunodeficiencies, autoimmune and systemic inflammatory diseases, and in infectious diseases as effective therapy. In this work, we report a method of processing IVIG (lyophilized and liquid) from Cohn fraction II (FII) paste. MATERIALS AND METHODS: The process included the following steps: virus inactivation by heat in a solution of FII, ultrafiltration, treatment at pH 4 with traces of pepsin, diafiltration and final formulation. Optimizations for each step on a small scale are described. The method has been effectively scaled-up. RESULTS: The final product contained at least 99% monomers plus dimers of IgG, a low anti-complementary activity (AcA) < 1 CH50/mg, and the remaining quality parameters fell within the range fixed by the European Pharmacopoeia. CONCLUSION: The method described is an effective way of preparing large quantities of IVIG (lyophilized and liquid) which fulfils the standard requirements of both the European Pharmacopoeia and the World Health Organization.
Asunto(s)
Inmunoglobulina G , Inmunoglobulinas Intravenosas , Liofilización , HumanosRESUMEN
Serum pregnancy-associated alpha 2-glycoprotein (alpha 2-PAG) levels were evaluated in a follow-up study of patients with hepatitis B virus (HBV) infection and compared with biochemical and virological parameters. In a study of 25 patients with acute hepatitis, an association was found between high alpha 2-PAG values, ALT levels, and HBsAg in 20 patients (80%) (P less than 0.05), 18 recovered completely, and 2 had a protracted course. In five patients serum alpha 2-PAG levels were similar to those in the control group. On the other hand, eight (100%) chronic persistent HBV patients showed high levels of alpha 2-PAG (P less than 0.05) during the study period, and these levels correlated well with inflammatory activity and failure of HBsAg elimination. There were no significant differences in alpha 2-PAG values between asymptomatic HBsAg carriers and controls. Serial analysis of alpha 2-PAG, in correlation with viral markers, biochemical parameters, and histological data, would contribute to the ability to predict the final outcome of HBV infection.