Development of a quantitative assay for residual host cell proteins in a recombinant subunit vaccine against human respiratory syncytial virus.

Abstract:

:We have developed and validated a process-specific immunoligand assay based on the Threshold system for the quantification of residual host cell proteins (HCPs) in a recombinant subunit vaccine candidate against the human respiratory syncytial virus (hRSV). The industrial process of this vaccine produced in Escherichia coli, involved five chromatography steps for the production of clinical-grade batches. The clearance of non-product-related protein throughout the purification process was documented by the evaluation of the HCP content in the chromatographic fractions at each step of the downstream processing. The assay had a detection limit of 0.5 ng/ml of HCP equivalent to 10 parts per million (ppm). The quantification limit was 1.3 ng/ml of HCP, giving a sensitivity range of the assay of 10 to 30 ppm. To our knowledge, this is the first sensitive HCP assay reported for a vaccine.

journal_name

J Immunol Methods

authors

Dagouassat N,Haeuw JF,Robillard V,Damien F,Libon C,Corvaïa N,Lawny F,Nguyen TN,Bonnefoy JY,Beck A

doi

10.1016/s0022-1759(01)00321-0

keywords:

subject

Has Abstract

pub_date

2001-05-01 00:00:00

pages

151-9

issue

1-2

eissn

0022-1759

issn

1872-7905

pii

S0022175901003210

journal_volume

251

pub_type

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