Purification Process

IBSA has patented exclusive extraction and purification processes and installed equipment dedicated to the production of fertility hormones, gonadotropins, using the urine of pregnant and post-menopausal donors.

The fertility hormone range is produced in compliance with the highest purity, efficacy and safety standards, whilst keeping the structure of the glycoproteins intact. Combining advanced technologies with a full awareness of the relationship between the structure and function of gonadotropins has made the processes patented by IBSA a quality benchmark.

This purification process consists of two steps:

a. Collection of urine from post-menopausal or pregnant women and initial purification

Every day the urine of pregnant or post-menopausal donors is collected in rural Chinese villages. Each donation of pregnant or post-menopausal urine is selected on the basis of conformity with specific stringent chemical and physical parameters and is obtained from healthy  women.

The approved urine then undergoes a number of purification steps (ultrafiltration, precipitation, filtration, chromatography, drying, etc.) in separate systems. Only those intermediates that meet the standards with regard to purity, specific activity and viral safety (absence of contamination from viruses such as HIV, HBV and HCV) are sent to the Biological Active Ingredients Department in Cadempino and Lamone.

b. Final purification and vial-filling

The ultrapurification of the gonadotropins, the most important step in the entire production process, takes place in the Biological Active Ingredients department of IBSA’s Swiss plants in Cadempino and Lamone. Before being forwarded for the purification cycle, the dried extracts undergo stringent testing in the Quality Control department in order to confirm their compliance with quality specifications.

At the end of the process, the purified hormones, in batches of a few grams, are freeze-dried, in a sterile environment, in single-dose vials, to obtain the finished product.

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