The biotechnology as a service (BaaS) company wants to boost biologics manufacturing in the company – noting a particular opportunity for the uptake of biosimilars - cutting import costs and thus encouraging the local industry to develop.
“Brazilian universities, startups, and medium-large companies face enormous challenges in developing biological Active Pharmaceutical Ingredients (APIs),” notes the company.
“These difficulties are evidenced by the low number of biopharmaceutical products launched through 100% Brazilian research, a sub-optimal biological manufacturing capacity (only 2.19% of global manufacturing capacity is in South America), the low number of facilities with an active GMP certification, and the very high cost of importing biological products ($1.3bn in 2015).
“Among many causes, this has occurred chiefly due to the absence of any Brazilian biological CDMOs, despite the existence of more than 500 worldwide.”
Recent efforts have sought to change the ‘historically discouraging’ biopharmaceutical scenario in Brazil. For example, the Brazilian government has legislated several industry incentives and the Brazilian Health Regulatory Agency is also enforcing strict adherence to ICH guidelines.
“The impact of building the CDMO goes far beyond the financials. Biotimize will help build the foundation for a growing scientific community that currently has no structure for development or GMP production,” says Fernando Barbosa, CEO of Biotimize.
A 32,000 square-foot parcel of land has been donated to Biotimize by the City of Piracicaba, and Biotimize is negotiating partnerships with equipment suppliers, centers of API characterization and GMP training organizations.
“The CDMO will have independent upstream suites for mammalian cell cultures focused on recombinant protein production, like monoclonal antibodies. This is especially important for a country with over 200 million inhabitants and a large potential market for biosimilars,” added Fernando.