Applications of quantitative PCR in the biosafety and genetic stability assessment of biotechnology products.
J Biotechnol
; 82(3): 279-300, 2002 Jan.
Article
em En
| MEDLINE
| ID: mdl-11999695
ABSTRACT
High throughput screening, increased accuracy and the coupling of real-time quantitative PCR (Q-PCR) to robotic set-up systems are beginning to revolutionise biotechnology. Applications of Q-PCR within biotechnology are discussed with particular emphasis on the following areas of biosafety and genetic stability testing (a) determination of the biodistribution of gene therapy vectors in animals; (b) quantification of the residual DNA in final product therapeutics; (c) detection of viral and bacterial nucleic acid in contaminated cell banks and final products; (d) quantification of the level of virus removal in process validation viral clearance studies; (e) specific detection of retroviral RT activity in vaccines with high sensitivity; and (f) transgene copy number determination for monitoring genetic stability during production. Methods employed for Q-PCR assay validation as required in ICH Topic Q2A Validation of Analytical Methods:
Definitions and Terminology (1st June 1995) are also reviewed.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Biotecnologia
/
DNA
/
Reação em Cadeia da Polimerase
Idioma:
En
Revista:
J Biotechnol
Assunto da revista:
BIOTECNOLOGIA
Ano de publicação:
2002
Tipo de documento:
Article
País de afiliação:
Reino Unido