The Preclinical Research Unit (UNIPREC) of the Faculty of Chemistry of the National Autonomous University of Mexico (UNAM) is a high quality laboratory responsible for evaluating health supplies for through regulated preclinical research.

Regulated preclinical research is the (set of) effectiveness and safety studies carried out under a very rigorous quality management system to evaluate health supplies,” explained the Director of UNIPREC, MSc Isabel Gracía Mora.

García Mora also said that the management system used in the unit complies with all international standards, allowing reliability through the traceability of preclinical studies for regulatory purposes.

Among the products evaluated in the unit, are industrial chemical products, food additives, phytomedicines, biotechnological drugs, pharmaceuticals, agrochemicals, vaccines, genetically modified organisms (GMOs) and medical devices.

The studies conducted in the UNIPREC are recognized in any country, thanks to the certifications by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and of the Organization for the Cooperation and Economic Development (OECD).

Patents and molecules

Among the studies done in the Faculty of Chemistry of the UNAM, UNIPREC researchers conduct biocomparability test. When a medicine’s patent expires, a bioequivalent version, i.e. exactly the same molecule, can be develop to launch a cheaper into the market. However, not in all cases the formula of the drug that has lost the patent can be replicated to perfection, so UNIPREC do the studies to see if these molecules are biocomparable and can be used without risk, while having similar effects to those caused by the original molecule.

Biocomparable drugs are defined as non-innovative treatments that have demonstrated quality, efficacy and safety comparable to those of the reference medicine. Biocomparable medicines do not have components equivalent to the innovative biotechnological ones, so they do not cause exact effects on the originals, but rather ‘similar’ ones on the organism.

Biocomparability tests “are the necessary studies to be certain that the drugs in question are comparable in terms of activity and safety,” said teacher Isabel Gracia in an interview with the Agencia Informativa Conacyt.

Also in the Unit they do biocompatibility studies, used to know if a medical device is safe for use in the human body. In this area, they work with polymers and other materials used in medical equipment, prostheses, orthoses, functional aids and other support instruments in surgeries and diagnosis.

The Unit has a large infrastructure that includes five animal experimentation rooms, a tissue culture laboratory, an immunology laboratory, a clinical pathology laboratory and a pathology laboratory, a file area, a quality assurance area and an advanced statistical area.

The multidisciplinary areas allow executing studies with a lot of complexity. According to UNIPREC data, in 2018, 30 projects of different products were evaluated in the Unit.

Isabel Gracia explained that the work of the Unit is essential so that small and medium enterprises in Mexico can boost scientific innovation and with it economic growth, in the process of reducing the inequality gaps between its inhabitants.

 

Source: Agencia Informativa CONACYT