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

Regulatory Implications of Gonal-F FbM

Gonal-F FbM represents a significant technological advance over current FSH products and scientific data supporting its development and use have been submitted to both the FDA and the EMEA. During the registration process of Gonal-F, both agencies asked Serono to consider developing the FbM process in order to improve batch-to-batch consistency further. This request follows a general regulatory trend (and in fact a commitment of the European Pharmacopoeia Commission) to reduce animal usage, wherever possible, in testing of pharmaceuticals. Regulatory agencies increasingly require manufacturers of biopharmaceutical products to replace in vivo and/or in vitro bioassay procedures by more sophisticated physico-chemical analytical methods providing more adequate pharmaceutical control. Recombinant human growth hormone and recombinant human insulin are examples of protein products that pharmacopoeial monographs require to be tested for potency by physico-chemical methods. Indeed, the rapid scientific progress in biopharmaceutical analysis has made state-of-the-art, highly computerised analytical methodology available for quality control purposes.

Serono is committed to the use of SE-HPLC methodology to test Gonal-F FbM (and other gonadotrophins) for potency. This choice required, as explained before, that the r-hFSH product produced by Serono had to be thoroughly characterised to understand in detail the physico-chemical properties of the product. In addition, the manufacturing process had to be optimised and thoroughly validated to demonstrate that a highly consistent r-hFSH product is obtained, from batch to batch, under routine manufacturing conditions. Lastly, the SE-HPLC method had to be optimised, and validated in agreement with International Conference on Harmonisation (ICH) guidelines, to be able to support a 90-110% protein content specification range.

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