New approaches for characterization of the genetic stability of vaccine cell lines.
Hum Vaccin Immunother
; 13(7): 1669-1672, 2017 07 03.
Article
em En
| MEDLINE
| ID: mdl-28333573
ABSTRACT
The genetic stability of cell lines is a critical analytical attribute required to demonstrate the quality of cells over time. During cell passage, mutations can arise in the genomic DNA, potentially leading to changes in the final vaccine product. The identity and integrity of master cell banks, extended cell banks, complementing cell lines or recombinant cell lines expressing transgenes has to be tested throughout the production process by the vaccine manufacturer. Over the past few years, the traditional methods for evaluation of genetic stability have been replaced with molecular approaches including quantitative PCR, digital PCR and high throughput sequencing. However, these molecular-based approaches are used in research laboratories and not within a GMP-compliant environment. In this article, we briefly discuss some opportunities and challenges in characterization of the genetic stability of vaccine cell lines with these molecular-based approaches.
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Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Vacinas
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Linhagem Celular
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Tecnologia Farmacêutica
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Instabilidade Genômica
Limite:
Animals
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Humans
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article