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What is Filled By Mass?
Reproductive hormones are complex molecules, consisting of families of isoforms (different forms of a protein that may be produced from different genes) whose profile determines the biological activity of a product.
The advent of Recombinant Technology has allowed a more defined product to be prepared, but hand in hand with this goes the need for a more exact method for the assessment of the quality of each batch produced. The traditional biological assay using rats has an inherent variability of 20%.
Timeline: Advances in Hormone Production
With traditional FSH production methods, isoform profiles vary from batch to batch, and therefore have a different bioactivity batch-to-batch. In these cases, the method for determining bioactivity is to perform an in vivo weight gain bioassay, with rats.
A more accurate and precise assay has now been achieved, using size-exclusion, high-pressure liquid chromatography, in which the calculated weight of protein consistently delivers the same biologic activity.
This method eliminates the intrinsic variability of the rat bioassay and ensures high batch-to-batch consistency of
Studies have shown that the higher consistency created when using the Filled by Mass methodology translates into improved clinical benefits that include:
Precise Dose
As a result of the Filled-by-Mass manufacturing process, the specific dosage prescribed by the physician relates to the exact quantity of active ingredient delivered to the patient.
Highly Efficacious
Filled by Mass hormones are highly efficacious. They provide a large number of high quality eggs (oocytes) and embryos, criteria associated with an increased likelihood of achieving clinical pregnancy in OI and ART.
Safety
The Filled by Mass manufacturing process has a good safety and tolerability profile, leading to greater patient acceptance.
Make sure you speak to your doctor or fertility specialist about the different treatments available and get one that suits you.
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Merck Serono S.A. Please read our Legal Statement. US residents should consult the Serono, Inc. fertility website at www.fertilitylifelines.com Last updated: 14/05/2008 |  |
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