The European Medicines Agency (EMA) is out with a new draft guideline intended for sponsors of human urine-based products, saying a standardized approach is needed to ensure that products are free from dangerous contaminants.
As regulators explain in the guideline-on the adventitious agent safety of urine-derived medicinal products-human urine is used in several products, including human chorionic gonadoptropin (hCG), human menopausal gonadotropin or menotropin (HMG) and follicle-stimulating hormone (FSH) and urokinase products used for thrombolysis.
Contrary to popular belief, however, urine is not inherently sterile. It can be contaminated with viruses found in the urinary tract, as well as protein-based diseases like variant Creutzfeldt-Jakob disease (vCJD). Accordingly, urine-based products must be processed to clear them of potential viral or disease-causing contaminants.
New Draft Guideline
EMA's draft guidance takes a risk-based approach similar in concept to blood donation guidelines. First, companies should ensure that donors are screened using appropriate exclusion criteria to the extent possible. The selection of donors will depend on the product being produced, as some are derived from a very small group of patients, while others (i.e. urokinase) may be manufactured from larger donor pools.
Second, manufacturers are encouraged to process urine products in such a way as to inactivate or remove contaminants from the product. These capabilities should be backed by data supporting defined steps in the manufacturing process. Regulators cited pasteurization or nanofiltration as possible methods.
Regulators recommend screening for a wide range of specific viruses, including those found directly in the urine, but also in fecal matter as well.
Finally, EMA said manufacturers need to perform risk assessments for the overall transmission risks associated with urine-derived medicinal products, saying that some procedures for collecting urine may be less safe than others.
Among the factors to consider are the viral epidemiology of the region around the collection location (i.e. geographical location), donor selection criteria, the use of pooling, hygiene procedures and purification methodologies.
Comments on the Guideline will be accepted until 31 May 2014.
On the adventitious agent safety of urine-derived medicinal products