EBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies.
Bioanalysis
; 6(10): 1409-13, 2014 May.
Article
em En
| MEDLINE
| ID: mdl-24958124
ABSTRACT
Long- and short-term stability testing of the analyte is one of the key parameters in bioanalytical method validation in support of pharmacokinetics. However, for immunogenicity testing, the scientific rationale for long- and short-term stability testing on quality control samples most often spiked with polyclonal antibody raised in a different species should be questioned. Therefore, the European Bioanalysis Forum (EBF) formed a Topic Team to discuss the scientific rationale for stability testing of anti-drug antibodies (ADAs). A review of EBF member companies' experience on ADA stability and on anti-vaccine antibodies from vaccine projects was the basis of this discussion. EBF recommends to perform short-term stability testing of the positive control, but not to perform long-term stability testing of ADAs in nonclinical and clinical studies.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vacinas
/
Anticorpos
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Dinamarca