ABSTRACT
The demand for medicinal products derived from plasmas are increasing on a global scale. In particular, the demand for intravenous immunoglobulin has continuously been increasing. The increase in the capacity of commercial plasma fractionators is prominent compared with that of non-profit plasma fractionators; thus, the percentage of plasmapheresis has increased with respect to that of plasma from whole blood. The inequality between the consumption of plasma-derived medicinal products and supply of raw plasma among developed countries and developing countries is due to the direct, proportional relationship between the consumption of plasma-derived medicinal products and the size of gross domestic products. Each country decides on its own system to achieve a stable supply of plasma-derived medicinal products. Although domestic production is an ideal option, many countries establish contracts with plasma fractionators. Owing to a great ripple effect, safety measures are increasingly applied, so detailed review should be conducted with consideration given to the cost-effectiveness and the situation unique to each country.
Subject(s)
Blood Coagulation Factors , Developed Countries , Developing Countries , Gross Domestic Product , Immunoglobulins , Plasma , Plasmapheresis , Socioeconomic FactorsABSTRACT
Dengue represents an important health problem in Brazil and therefore there is a great need to develop a vaccine or treatment. The neutralization of the dengue virus by a specific antibody can potentially be applied to therapy. The present paper describes, for the first time, the preparation of Immunoglobulin specific for the dengue virus (anti-DENV IgG), collected from screened Brazilian blood-donations. Production was performed using the classic Cohn-Oncley process with minor modifications. The anti-DENV IgG was biochemically and biophysically characterized and fulfilled the requirements defined by the European Pharmacopoeia. The finished product was able to neutralize different virus serotypes (DENV-1, DENV-2, and DENV-3), while a commercial IgG collected from American blood donations was found to have low anti-dengue antibody titers. Overall, this anti-DENV IgG represents an important step in the study of the therapeutic potential and safety of a specific antibody that neutralizes the dengue virus in humans.
A dengue representa um importante problema de saúde no Brasil, portanto, a identificação de vacina ou tratamento eficaz é uma necessidade urgente. A neutralização do vírus da dengue, por anticorpo específico, tem potencial aplicação terapêutica. Descrevemos aqui, pela primeira vez, a preparação de imunoglobulina específica para o vírus da dengue (IgG anti-DENV), produzida a partir do plasma selecionado de doadores brasileiros. A produção foi realizada utilizando o método clássico de Cohn-Oncley com pequenas modificações. A IgG anti-DENV foi bioquimicamente e biofisicamente caracterizada e cumpriu os requisitos definidos pela Farmacopeia Europeia. O produto final foi capaz de neutralizar diferentes sorotipos do vírus (DENV-1, DENV-2 e DENV-3), enquanto que a IgG comercial, produzida a partir do plasma de doadores americanos, apresentou baixos títulos de anticorpos anti-dengue. No geral, esta IgG anti-DENV representa uma importante etapa para o estudo do potencial terapêutico e segurança da neutralização, por anticorpos específicos, do vírus da dengue em humanos.