When it comes to Biotechnology, Cristália is way ahead its competitors. The company owns two certified technology plants for manufacturing APIs for Biologicals, opened, respectively, in 2013 and 2014, and already in full operation.
The opening of its Biotechnology plants is a milestone for Cristália and for Brazil, as well as a proof that the company is one of industry’s global benchmarks.
But, what does Biotechnology mean? It’s the science able to produce biological drugs with high therapeutic potential.
While synthetic drugs are obtained from traditional processes, resulting in molecules with a clear chemical structure, biological drugs are complex molecules obtained from cells growing under controlled conditions.
Those drugs are a breakthrough for the treatment of several diseases and disorders, such as cancer and growth deficit, providing patients with an improved quality of life and welfare.
The first Biotechnology plant opened by Cristália was granted, in March 2014, with a Good Manufacturing Practices Certification (GMPC) by the Brazilian regulatory agency – Anvisa – for the APIs (Active Pharmaceutical Inputs) trastuzumab, for manufacturing state-of-the-art medicines designed to treat breast cancer, and; somatropin, to produce a hormone employed in the treatment of children with growth deficit.
That was the first time that a local pharmaceutical company has received approval for manufacturing biological inputs. Currently under clinical trials, those drugs are strategically important for the country, and reflect a renewal for local science to the benefit of Brazilian production.
The second biotechnology plant using a manufacturing platform containing anaerobic microorganisms was also granted with a GMPC in late 2014, and is totally dedicated to the manufacturing of the Biological Pharmaceutical Input collagenase, a substance employed in the manufacturing of Cristália’s animal-free Kollagenase ointment.
Intended to treat wounds, ulcers, and burns, Cristália has been marketing its animal-free Kollagenase ointment since 1979, but now the product is manufactured using an input developed by Brazilian scientists by means of processes that use microorganisms extracted from local biodiversity.
Before that accomplishment, all Biological APIs employed in the production of ointments using these enzymes were imported.