Impact of residual impurities and contaminants on protein stability.
J Pharm Sci
; 103(5): 1315-30, 2014 May.
Article
em En
| MEDLINE
| ID: mdl-24623189
ABSTRACT
Production of recombinant proteins generates a variety of process-related impurities. The multistep manufacturing processes may introduce many potential contaminants into the final pharmaceutical products. These residual impurities and contaminants can potentially impact the protein stability significantly. In this short review, the authors intend to discuss major sources and types of residual process-related impurities and potential product contaminants, their impact on protein quality/stability, and possible mitigations during product development and manufacturing processes.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Proteínas Recombinantes
/
Contaminação de Medicamentos
/
Estabilidade Proteica
Limite:
Humans
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article