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Following initiatives of the ECVAM Task Force on the Quality Control of Hormones, a prevalidation study of physicochemical methods for predicting the in-vivo biological potency of recombinant follicle stimulating hormone (rFSH), supported by ECVAM and co-ordinated by the National Institute for Biological Standards and Control, was carried out by 6 laboratories from 6 countries. Two methods for predicting the specific in-vivo bioactivity of rFSH, based on quantitative measures of isoform distribution by isoelectric focusing and by capillary zone electrophoresis respectively, were each used to estimate the predicted bioactivities of four preparations of follitropin beta differing in their isoform compositions and specific bioactivities. The results of this study suggest that these methods, and particularly IEF, are sufficiently accurate, precise and robust to be used for predicting the bioactivity of batches of follitropin beta, and especially if used with a standard preparation.

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Authors: STORRING P L, National Institute for Biological Standards and Control, Potters Bar (GB);GAINES DAS R E, National Institute for Biological Standards and Control, Potters Bar (GB);MULDERS J W M, N.V. Organon, Oss (NL);HALDER M, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, European Centre for the Validation of Alternative Methods (ECVAM), Ispra (IT)
Bibliographic Reference: An oral report given at: International IABs Symposium on Elimination of the Use of Laboratory Animals for Development of Vaccines and Hormones Organised by: International Association for Biologicals Held at: Utrecht, 12-14 November 2001
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