Extensive analyses have shown that Serono's r-hFSH (Gonal-F) has extremely high physico-chemical and biological consistency, which is reflected in its status as the first FbM r-hFSH. As a result, Gonal-F can now be characterised by non-bioassay methodology; Serono uses an optimised SE-HPLC technique for quantification of r-hFSH protein in both the drug substance and final product. Not only is this method far more precise than the Steelman-Pohley in vivo bioassay, representing a significant improvement in product quality and batch-to-batch consistency, but it also reduces the necessity to sacrifice tens of thousands of laboratory animals. In prescribing Gonal-F FbM, clinicians can be assured that they are using a product manufactured to the highest standards of quality and consistency that delivers a guaranteed dose. In conclusion, therefore, in view of the well-known drawbacks of in vivo bioassay, methods such as SE-HPLC are likely to gain increasing popularity for quality testing and regulatory purposes, provided that the manufacturing process is well controlled, fully validated and results in a protein product of highly consistent physico-chemical properties.
Address for correspondence: R. Driebergen, Industria Farmaceutica Serono S.p.A., via Luigi Einaudi 11, 00011 Bagni di Tivoli, Rome, Italy. Tel. +39 0774 350 464; Fax +39 0774 358 040; email email@example.com
Curr Med Res Opin. 2003;19(1) © 2003 Librapharm Limited
Cite this: Quantification of Follicle Stimulating Hormone (follitropin alfa): Is In Vivo Bioassay Still Relevant in the Recombinant Age? - Medscape - Jan 01, 2003.