In an unprecedented model in the country, Biotimize opens a laboratory to development of active biological inputs in Brazil
Company is the first to work under GLP certification in Brazil to operate in the “as a service” model (CDMO) and will be the only one in South America to offer an end-to-end production service from of mammalian cells using only single-use equipment.
Biotimize opened on March 26, in Piracicaba (SP), the first service provider laboratory in Brazil capable of developing vaccines and biological medicines from living cells. The space is operated under Good Laboratory Practices (GLP), ensuring the basis for generating reliable pre-clinical data for regulatory submissions, and enabled with biosafety levels 1 and 2, necessary for work with monoclonal antibodies and viruses.
This is the first laboratory in the country to operate under the “as a service” model, that is, capable of providing services to global universities and companies under GLP conditions, and the only one to operate with end-to-end production from bacteria, yeast, mammalian cells and viruses.
“The fact that Brazil does not have a CDMO directly impacts the production chain, with universities, startups and companies facing enormous difficulties in the development of biological Active Pharmaceutical Ingredients (API), comments Fernando Barbosa, CEO of Biotimize. “Having to look for this outside the country means more bureaucracy, more time and more costs, causing many promising researches to fail to evolve or to evolve outside of Brazil,
failing to benefit those who need it most.”
In addition to the current structure, Biotimize will begin, later this year, the construction of a new biological R&D Center of approximately 600 m2 and a production platform for clinical and commercial batches, of approximately 4,000 m2, based on the Good Manufacturing Practices (ANVISA/FDA/EMA). The GMP structure, focusing on the production of recombinant proteins from mammalian cells, will have three independent production streams, with structure for purification and Fill & Finish all single-use, and will be the only one in South America to offer a complete solution for the development of a biological medicine, comprising research and development, production, formulation and characterization. The project is supported by Sthorm, a Brazilian intelligence dedicated to technological development and scientific discoveries to solve global problems.
“This is a significant milestone in our journey to promote innovation and excellence in the manufacturing of pharmaceutical and biotechnology products in Brazil. We are moving forward so that the country is self-sufficient in all phases of this ecosystem, attracting investments, retaining talent and locally developing products that can reach those in need faster, directly impacting public health and democratizing access to science and healing”, he adds. Fernando.
The inauguration of the laboratory, which is an important part of the actions to strengthen the Health Economic-Industrial Complex and New Industry Brazil, was attended by the mayor of the city of Piracicaba, in addition to representatives of the main players in the country's pharmaceutical sector, and government representatives.
