title: Standardization of human IL-29 (IFN-λ1): establishment of a World Health Organization international reference reagent for IL-29 (IFN-λ1).
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.
authors: 1 Cytokine and Growth Factors Section, Biotherapeutics Group, NIBSC, Medicines and Healthcare Products Regulatory Agency , Hertfordshire, United Kingdom .
authors: Anthony
authors: A
authors: Meager
authors: Alan
authors: A
authors: Heath
authors: Paula
authors: P
authors: Dilger
authors: Kathryn
authors: K
authors: Zoon
authors: Meenu
authors: M
authors: Wadhwa
mesh_terms: D000818:Animals; D002460:Cell Line; D002908:Chronic Disease; D004926:Escherichia coli / Q000235:genetics; D006526:Hepatitis C / Q000276:immunology / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D007372:Interferons; D007378:Interleukins / Q000592:standards* / Q000627:therapeutic use; D007391:International Cooperation; D051379:Mice; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D055550:Protein Stability; D011994:Recombinant Proteins / Q000592:standards* / Q000627:therapeutic use; D012015:Reference Standards; D014944:World Health Organization; D000095022:Interferon Lambda
chemical_list: D007372:Interferons; D007378:Interleukins; D011994:Recombinant Proteins; C000624353:interferon-lambda, human; D000095022:Interferon Lambda