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J Immunol Methods. 2001 May 1;251(1-2):151-9.

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

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1
Centre d'Immunologie Pierre Fabre (CIPF), 5 Avenue Napoléon III, B.P. 497, F-74164, Saint-Julien-en-Genevois, France. nathalie.dagouassat@pierre-fabre.com

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.

PMID:
11292490
[Indexed for MEDLINE]
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