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IBSA is confirmed one of the global "gold standards" in the field of therapeutic gonadotropin

19 November 2021

WHO (World Health Organization) considers infertility a disease. Due to its complexity, the field of medically assisted procreation (MAP) has always represented a great challenge for the pharmaceutical sector. 

IBSA’s product portfolio offers different solutions for the treatment of infertility, such as highly glycosylated gonadotropins of human origin and progesterone in aqueous solution. For gonadotropins production, IBSA has patented an exclusive extraction and purification process which starts from the urine of pregnant and menopausal women.

Recognising the company’s laboratories experience and expertise as one of the best in the world, WHO certified IBSA’s quality with the “International Golden Standard” once again.

WHAT ARE GONADOTROPINS AND WHAT IS THE IMPORTANCE OF THE IBSA PATENTED PURIFICATION PROCESS

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Gonadotropins are a family of three hormones: FSH (follicle-stimulating hormone), LH (luteinising hormone) and hCG (human chorionic gonadotropin) and they all can be of either extractive or recombinant origin.

IBSA’s gonadotropins are of extractive origin and are produced abiding to the highest safety and effectiveness standards, through a patented purification process leveraging on advanced technologies. These allow to protect the synergy between activity and function of the gonadotropins, while preserving their glycoproteic structure.

WHAT IT MEANS TO BE RECOGNISED AS FERTILITY HORMONES “INTERNATIONAL GOLD STANDARD”

A crucial part of quality management is measuring and evaluating a given therapy against a set standard. When producing therapies, each laboratory must rate the therapy's active ingredients concentration that strictly follows international benchmarks.

As Tiziano Fossati, Head of Pharmaceutical Research & Development at IBSA explains: “Any biological activity is not measurable and quantifiable applying the same criteria as the more common chemical-physical quantities. When it comes to the dosage of a biological therapy, determining the absolute quantity just by weight (example: milligrams) is not enough; it is necessary instead to correlate the quantity of active principle to its biological response.” For this very reason, WHO regularly establishes international reference standards. “The reference standard is in fact determined on the basis of its response within a complex biological system; the standard of choice can therefore be defined as the 'international reference standard'. Only very few laboratories in the world participate in the definition of the 'international reference standard': it is possible to identify these laboratories as the 'gold standards', meaning benchmark laboratories that have fully acquired the necessary experience to determine the biological activity of gonadotropins. It is a result that was achieved by IBSA more than ten years ago, and this long-running reconfirmation certifies the relentless commitment to consistent updating and innovation in the field of treatments for infertility. It is a result that fills all IBSA researchers and technicians with pride,” concludes Fossati.

In order to obtain fertility hormones standards, WHO resorts to very few highly qualified laboratories around the world, whose capability to carry out high-precision analysis has been officially acknowledged. Among these are the IBSA laboratory in Montagnola, in Collina d'Oro, Canton Ticino, a laboratory with an almost twenty-year history that has been running tests on thousands of batches of gonadotropins, both produced by IBSA and both from other providers, every year.

But how exactly does standard setting work? In recent months, IBSA has received and analysed standard FSH samples without knowing their value (blind analysis) and has submitted the results to WHO. The data provided by IBSA were found to be aligned with the top of the world standard and have therefore become a benchmark. This means that the international standard IBSA contributed to create (by analyzing it) will be employed as an evaluation tool for quality control in the next years.

This milestone is not new for IBSA, as Walter De Matteo, Head of Quality Control tells us: “WHO has involved our Quality Control laboratories in the definition of the fertility hormone dosage standard for over 10 years. Indeed, only two years ago IBSA participated in the definition of the gold standard for the hormone hCG. These recurring recognitions confirm the high level of technological expertise, and reward the consistent and relentless commitment of IBSA in guaranteeing its products quality.”

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