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 app...

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Detalles Bibliográficos
Autores principales: Mila C., Loreley, Valdes, Rodolfo, Padilla, Sigifredo, Mendoza, Otto, Gomez, Leonardo, García A., Cristina, Geada, Déborah, Ferro, Williams, Pujol, Merardo, Tamayo, Andrés, Enriquez, Gil, Álvarez, Tatiana, Sanchez, Rafael, Brito, José
Formato: Articulo
Lenguaje:Inglés
Publicado: 2010
Materias:
Farmacia
Farmacología
biopharmaceuticals; hepatitis B vaccine; plantibody; quality risk management
Biofarmaceútica
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/7922
http://www.latamjpharm.org/resumenes/29/3/LAJOP_29_3_1_9.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-7922
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
Farmacología
biopharmaceuticals; hepatitis B vaccine; plantibody; quality risk management
Biofarmaceútica
spellingShingle Farmacia
Farmacología
biopharmaceuticals; hepatitis B vaccine; plantibody; quality risk management
Biofarmaceútica
Mila C., Loreley
Valdes, Rodolfo
Padilla, Sigifredo
Mendoza, Otto
Gomez, Leonardo
García A., Cristina
Geada, Déborah
Ferro, Williams
Pujol, Merardo
Tamayo, Andrés
Enriquez, Gil
Álvarez, Tatiana
Sanchez, Rafael
Brito, José
Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production
topic_facet Farmacia
Farmacología
biopharmaceuticals; hepatitis B vaccine; plantibody; quality risk management
Biofarmaceútica
description 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.
format Articulo
Articulo
author Mila C., Loreley
Valdes, Rodolfo
Padilla, Sigifredo
Mendoza, Otto
Gomez, Leonardo
García A., Cristina
Geada, Déborah
Ferro, Williams
Pujol, Merardo
Tamayo, Andrés
Enriquez, Gil
Álvarez, Tatiana
Sanchez, Rafael
Brito, José
author_facet Mila C., Loreley
Valdes, Rodolfo
Padilla, Sigifredo
Mendoza, Otto
Gomez, Leonardo
García A., Cristina
Geada, Déborah
Ferro, Williams
Pujol, Merardo
Tamayo, Andrés
Enriquez, Gil
Álvarez, Tatiana
Sanchez, Rafael
Brito, José
author_sort Mila C., Loreley
title Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production
title_short Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production
title_full Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production
title_fullStr Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production
title_full_unstemmed Using quality risk management in the plantibody HB-01 manufacturing by transgenic tobacco Plants for vaccine production
title_sort using quality risk management in the plantibody hb-01 manufacturing by transgenic tobacco plants for vaccine production
publishDate 2010
url http://sedici.unlp.edu.ar/handle/10915/7922
http://www.latamjpharm.org/resumenes/29/3/LAJOP_29_3_1_9.pdf
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