Human interleukin-29 (IL-29), a helical cytokine with interferon-like activities, is currently being developed as a clinical biotherapeutic to treat chronic hepatitis C infection and some cancers. As such, the World Health Organization (WHO) has recognized a need for biological standardization of IL-29 and the establishment of an internationally available reference reagent of IL-29. In order to accomplish this, an international collaborative study that evaluates WHO candidate reference reagents of IL-29 was instigated by the National Institute for Biological Standards and Control (NIBSC) in 2010 and was carried out in the succeeding year. Two preparations of human sequence recombinant IL-29, one expressed in murine NS0 cells and the other in Escherichia coli, were formulated and lyophilized at NIBSC before evaluation in the collaborative study for their suitability to serve as a reference reagent. The preparations were tested by 6 laboratories from 4 countries using in vitro bioassays and also evaluated for thermal stability within the NIBSC laboratory. On the basis of the results of the collaborative study, both preparations, 07/212 (NS0-derived) and 10/176 (E. coli-derived) were judged sufficiently active and stable to serve as a reference reagent. However, since IL-29 produced in E. coli is in development for clinical applications, it was recommended that the preparation coded 10/176 be established as the WHO international reference reagent for human IL-29. This recommendation was accepted, and the IL-29 preparation coded 10/176 was formally established by the WHO ECBS at its meeting in October 2012 as the WHO international reference reagent for IL-29 with an assigned unitage of 5,000 reference units per ampoule.

Standardization of human IL-29 (IFN-λ1): establishment of a World Health Organization international reference reagent for IL-29 (IFN-λ1) / Meager, A; Heath, A; Dilger, P; Zoon, K; Wadhwa, M; Zoon, K; Bekisz, J; Donnelly, R; Antonelli, Guido; Scagnolari, Carolina; Kotenko, S; Tovey, M; Dilger, P; Bird, C; Meager, A.. - In: JOURNAL OF INTERFERON AND CYTOKINE RESEARCH. - ISSN 1079-9907. - STAMPA. - 34:(2014), pp. 876-884. [10.1089/jir.2014.0015]

Standardization of human IL-29 (IFN-λ1): establishment of a World Health Organization international reference reagent for IL-29 (IFN-λ1).

ANTONELLI, Guido;SCAGNOLARI, CAROLINA;
2014

Abstract

Human interleukin-29 (IL-29), a helical cytokine with interferon-like activities, is currently being developed as a clinical biotherapeutic to treat chronic hepatitis C infection and some cancers. As such, the World Health Organization (WHO) has recognized a need for biological standardization of IL-29 and the establishment of an internationally available reference reagent of IL-29. In order to accomplish this, an international collaborative study that evaluates WHO candidate reference reagents of IL-29 was instigated by the National Institute for Biological Standards and Control (NIBSC) in 2010 and was carried out in the succeeding year. Two preparations of human sequence recombinant IL-29, one expressed in murine NS0 cells and the other in Escherichia coli, were formulated and lyophilized at NIBSC before evaluation in the collaborative study for their suitability to serve as a reference reagent. The preparations were tested by 6 laboratories from 4 countries using in vitro bioassays and also evaluated for thermal stability within the NIBSC laboratory. On the basis of the results of the collaborative study, both preparations, 07/212 (NS0-derived) and 10/176 (E. coli-derived) were judged sufficiently active and stable to serve as a reference reagent. However, since IL-29 produced in E. coli is in development for clinical applications, it was recommended that the preparation coded 10/176 be established as the WHO international reference reagent for human IL-29. This recommendation was accepted, and the IL-29 preparation coded 10/176 was formally established by the WHO ECBS at its meeting in October 2012 as the WHO international reference reagent for IL-29 with an assigned unitage of 5,000 reference units per ampoule.
2014
IFN, antiviral activity, bioassay
01 Pubblicazione su rivista::01a Articolo in rivista
Standardization of human IL-29 (IFN-λ1): establishment of a World Health Organization international reference reagent for IL-29 (IFN-λ1) / Meager, A; Heath, A; Dilger, P; Zoon, K; Wadhwa, M; Zoon, K; Bekisz, J; Donnelly, R; Antonelli, Guido; Scagnolari, Carolina; Kotenko, S; Tovey, M; Dilger, P; Bird, C; Meager, A.. - In: JOURNAL OF INTERFERON AND CYTOKINE RESEARCH. - ISSN 1079-9907. - STAMPA. - 34:(2014), pp. 876-884. [10.1089/jir.2014.0015]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/782177
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