The Biotechnology Manufacturing Plant, opened in 2013, has been designed to manufacture several different medicines, including critically important biological pharmaceutical inputs for Brazilian production.
The plant has been capacitated to work with Risk Class-1 genetically-modified organisms, employed in the manufacturing of biodrugs that are harmless to human health and to the environment.
Industrial biotechnology investigates biochemical processes and tries to replicate them to enable their use in the manufacturing of high value-added medicines. As a result, our investigators can develop improved processing techniques to be applied to bacteria, yeasts, and mammalian cells.
Therefore, the company can produce biologicals in large scale and in a safer manner, in addition to provide costs reduction. For patients, the advantage is their improved access to these medicines.
Following, you will know which biologicals are already being manufactured and tested at Cristália’s Biotechnology plant:
This Active Biological Pharmaceutical Input (API) is a monoclonal antibody used in the production of a drug designed to avoid metastasis in patients submitted to breast cancer therapy. It is also indicated to increase the life expectancy of patients who are already in advanced phases of the disease, i.e., when cancer has already spread to other organs.
Trastuzumab can be used as a single therapy or in combination with other chemotherapy agents. The manufacturing of that Biological API in Brazil will improve patients’ access to this cutting-edge therapy. According to SUS (Unified Healthcare System) data, only in Brazil, about 15 thousand women die every year because of breast cancer.
This is a Biological Pharmaceutical Input that mimics the Human Growth Hormone (rhGH) that naturally occurs in our body. That hormone is responsible for children growth to their final adulthood height.
In some cases, as a result of a gland failure called hypopituitarism, children cannot produce a sufficient amount of hormone to grow as expected. In such cases, if a child does not receive supplementary doses of rhGH, he or she would potentially grow as an adult to a substantially shorter height than the average population.
Somatropin supplementation is also indicated in cases of genetic syndromes, such as the Turner and Prader-Willi syndromes, and for the treatment of adults with endogenous rhGH deficiency or with idiopathic short stature.
Somatropin produced by Cristália uses a recombinant DNA technology on a prokaryotic expression platform. Many other Brazilian companies have attempted to synthesize rhGH, but failed to reach the required scale to make product marketing feasible. Cristália will be the first Brazilian pharmaceutical company to launch rhGH using 100% Brazilian technology.