Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production

The production of biopharmaceuticals by transgenic plants is a promising choice to achieve the multi-kilogram amount of products needed to treat many human diseases. However, this scientific field is still lacking of approved specific guidelines regarding points to consider for manufacturing and application of these products. In such sense, the implementation of new manufacturing processes and quality systems using the quality risks management is recognized as something of prime importance in the current pharmaceutical industry. In this work, we summarize the application of the FMEA method to design the manufacturing process of a plantibody, employed in the hepatitis B vaccine production to ensure the vaccine high quality.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production

The production of biopharmaceuticals by transgenic plants is a promising choice to achieve the multi-kilogram amount of products needed to treat many human diseases. However, this scientific field is still lacking of approved specific guidelines regarding points to consider for manufacturing and application of these products. In such sense, the implementation of new manufacturing processes and quality systems using the quality risks management is recognized as something of prime importance in the current pharmaceutical industry. In this work, we summarize the application of the FMEA method to design the manufacturing process of a plantibody, employed in the hepatitis B vaccine production to ensure the vaccine high quality.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production

The production of biopharmaceuticals by transgenic plants is a promising choice to achieve the multi-kilogram amount of products needed to treat many human diseases. However, this scientific field is still lacking of approved specific guidelines regarding points to consider for manufacturing and application of these products. In such sense, the implementation of new manufacturing processes and quality systems using the quality risks management is recognized as something of prime importance in the current pharmaceutical industry. In this work, we summarize the application of the FMEA method to design the manufacturing process of a plantibody, employed in the hepatitis B vaccine production to ensure the vaccine high quality.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Evaluación de extractos vegetales con propiedades biocidas en plagas del tabaco post-cosecha

Existen 8 millones de toneladas de tabaco almacenadas que son atacadas por insectos (Lasioderma serricorne F y Ephestia eleutella Hb) y hongos que ocasionan pérdidas que rebasan los 300 millones de dólares anuales.Para su control pueden ser empleados métodos eficaces, pero los inconvenientes de su uso los convierten en prohibidos. En el presente trabajo se evalúa la actividad biocida de extractos acuosos de plantas (higuereta, piñón, eucalipto y lantana) contra L. serricorne. Estos, a su vez, se obtuvieron mediante dos procedimientos diferentes. Los resultados mostraron una mortalidad entre 90-100% con los extractos evaluados a una concentración de las plantas del 75% y 100%, mientras que en otros tratamientos se observó una mortalidad del 5%. Estos resultados avizoran la presencia de potenciales sustancias biocidas que podrían incluirse en el manejo integrado de plagas en la industria tabacalera en las fases de poscosecha y de almacenamiento

Evaluación de extractos vegetales con propiedades biocidas en plagas del tabaco post-cosecha

Existen 8 millones de toneladas de tabaco almacenadas que son atacadas por insectos (Lasioderma serricorne F y Ephestia eleutella Hb) y hongos que ocasionan pérdidas que rebasan los 300 millones de dólares anuales.Para su control pueden ser empleados métodos eficaces, pero los inconvenientes de su uso los convierten en prohibidos. En el presente trabajo se evalúa la actividad biocida de extractos acuosos de plantas (higuereta, piñón, eucalipto y lantana) contra L. serricorne. Estos, a su vez, se obtuvieron mediante dos procedimientos diferentes. Los resultados mostraron una mortalidad entre 90-100% con los extractos evaluados a una concentración de las plantas del 75% y 100%, mientras que en otros tratamientos se observó una mortalidad del 5%. Estos resultados avizoran la presencia de potenciales sustancias biocidas que podrían incluirse en el manejo integrado de plagas en la industria tabacalera en las fases de poscosecha y de almacenamiento

Analysis of the influence of five variables on an established immunoaffinity chromatography procedure to purify a picchia pastoris yeast derived-HBsAg for pharmaceutical use

Immunoaffinity chromatography (IAC) has a wide application in protein purification. The aim of the study was to investigate the influence of five operational factors on an IAC procedure to purify a yeast derived-Hepatitis B surface antigen (rHBsAg) for pharmaceutical use. The immunosorbent adsorption capacity of the rHBsAg is affected at 4 °C. The applied antigen concentration, 100-1000 μg mL-1, does not have influence on this IAC efficiency. The residence time, applied antigen amount and column geometry have a significant influence on the adsorption and elution capacity, and recovery of the rHBsAg. There is a marked retention of the rHBsAg into the matrix, which is reduced at residence times higher than 2 h. A high height/diameter ratio of the column, 3.75, reduces the antigen adsorption to the matrix but increases the recovery and the productivity for this high molecular weight (multiple chemical forms) antigen and a high affinity constant ligand. The solution of the rHBsAg retention into the matrix could increase by 30% the active pharmaceutical ingredient purification and the Hepatitis B vaccine production.Colegio de Farmacéuticos de la Provincia de Buenos Aire