Quantification of Follicle Stimulating Hormone (follitropin alfa): Is In Vivo Bioassay Still Relevant in the Recombinant Age?

R. Driebergen, G. Baer

Disclosures

Curr Med Res Opin. 2003;19(1) 

In This Article

Alternative Physico-Chemical Methodology

Size exclusion high performance liquid chromatography (SE-HPLC) represents an alternative physico-chemical method by which Serono - the manufacturers of Gonal-F* (r-hFSH, follitropin-alfa) - are now able to quantify r-hFSH protein in both drug substance and final product with high reliability. This technique has far greater precision than the Steelman-Pohley in vivo bioassay (%CV 1-2% vs %CV 10%) and supports an intended 'target mass' ± 10% specification range. This represents a significant improvement in product quality and batch-to-batch consistency compared with the current protein content range of ± 23% for Gonal-F 75 IU vials/ampoules, filled by IU and released by bioassay against the 80-125% biopotency specification. The SE-HPLC method used is very robust and provides highly consistent analytical results at multiple laboratories, as shown in Table 1 . However, this optimised SE-HPLC method is only viable because:

  • The drug substance manufacturing process produces r-hFSH protein with a consistent physico-chemical quality

  • The compounding, filling and finishing process maintains the integrity of the r-hFSH molecule, ensuring consistent biological quality

  • A reliable conversion factor has been determined to calculate the equivalent of IU in µg.

*Gonal-F is a registered trade name of Serono S.A., Switzerland

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