Analysis of plasmid DNA from a pharmaceutical perspective.
J Pharm Sci
; 87(2): 130-46, 1998 Feb.
Article
em En
| MEDLINE
| ID: mdl-9519144
ABSTRACT
The advent of gene therapy and polynucleotide-based vaccines has resulted in the use of plasmid DNA as a drug substance. Although biologically (cell or animal) based assays must currently be employed to establish the identity and potency of such drugs, we argue that in the future, a combination of microchip-based mutation detection devices combined with an array of chromatographic, electrophoretic, hydrodynamic, and spectroscopic methods can be employed to rigorously establish these properties. We review a variety of such methods in this context and also consider the issue of the chemical stability of plasmids. Extensive comparison is made to protein-based pharmaceuticals with the unique importance of polynucleotide sequence emphasized in comparison to protein tertiary structure.
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Base de dados:
MEDLINE
Assunto principal:
Plasmídeos
/
Análise Mutacional de DNA
/
Técnicas de Química Analítica
Idioma:
En
Ano de publicação:
1998
Tipo de documento:
Article