For the thousand Brazilian patients who use ointments made of the Active Pharmaceutical Input (API) collagenase on a daily basis, one can hardly imagine the complex science behind something apparently so simple.
The ointment produced from the API collagenase provides a painless therapy for burns, bedsores, and ulcers. This medication is produced from an enzyme secreted by an anaerobic (i.e., surviving in an oxygen-free environment) bacteria known as Clostridium histolyticum, which can be found in certain types of soil samples.
While that ointment is extensively used by hospitals and patients throughout the country, it was not until recently that Brazil had to import the Active Pharmaceutical Biological Input (API) collagenase from the few pharmaceutical companies abroad that manufactured it.
In addition to make Brazil dependent on such an essential medicine, the costs for importing it were much higher, therefore reducing patients’ access to it. The novelty was globally presented by Cristália during 2016’s BIO International Convention – an important global fair and conference in the field of Biotechnology, which took place in San Francisco (USA).
On October 30th, 2014, Cristália Laboratories was granted with the Good Manufacturing Practices Certification (GMPC) for Active Biological Pharmaceutical Inputs applied to the Biotechnology – Anaerobics plant, located at Itapira (SP) Industrial Park.
At this plant, the API collagenase is manufactured, which has been vertically developed by the company using 100% Brazilian science.
With strong investments in research & development, Cristália’s scientists managed not only to produce the API, but also to develop an even safer input.
From samples collected at a rural property located in Espírito Santo do Pinhal - a city in the countryside of the state of São Paulo - an animal-free collagenase was developed, which, as opposite to the ordinary API, uses only vegetable extracts in its manufacturing process.
Research conducted by Cristália that led to such a revolution in Biotechnology have been reviewed and approved by CGEN (Genetic Heritage Management Council) for commercial use, consistently with local laws of access to biodiversity.