Evaluation of electrospray differential mobility analysis for virus particle analysis: Potential applications for biomanufacturing.
J Virol Methods
; 178(1-2): 201-8, 2011 Dec.
Article
em En
| MEDLINE
| ID: mdl-21963394
ABSTRACT
The technique of electrospray differential mobility analysis (ES-DMA) was examined as a potential potency assay for routine virus particle analysis in biomanufacturing environments (e.g., evaluation of vaccines and gene delivery products for lot release) in the context of the International Committee of Harmonisation (ICH) Q2 guidelines. ES-DMA is a rapid particle sizing method capable of characterizing certain aspects of the structure (such as capsid proteins) and obtaining complete size distributions of viruses and virus-like particles. It was shown that ES-DMA can distinguish intact virus particles from degraded particles and measure the concentration of virus particles when calibrated with nanoparticles of known concentration. The technique has a measurement uncertainty of ≈20%, is linear over nearly 3 orders of magnitude, and has a lower limit of detection of ≈10(9)particles/mL. This quantitative assay was demonstrated for non-enveloped viruses. It is expected that ES-DMA will be a useful method for applications involving production and quality control of vaccines and gene therapy vectors for human use.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Tamanho da Partícula
/
Vírion
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Virologia
Tipo de estudo:
Evaluation_studies
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Guideline
Limite:
Humans
Idioma:
En
Revista:
J Virol Methods
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Estados Unidos