How to overcome the biological manufacturing gap in Brazil

During the past decade, it has been seen a significant shift in the nature of the products manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today contains a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise in treatments for many orphan diseases. These trends have increased the number of biopharmaceutical products with extremely limited production runs, highly specific manufacturing requirements, and genotype-specific products (1).

The biopharmaceutical industry produces medicines that save, sustain, and improve lives. Biopharmaceuticals treat and prevent some of the most prevalent and debilitating diseases that affect human health, including cancer, diabetes, autoimmune disorders, and bacterial and viral infections. It resulted in one of the most valuable and important business sectors in the world. Unlike other medicines, biopharmaceuticals are manufactured in, extracted, or otherwise derived from biological sources and require complex raw materials, equipment and manufacturing processes, and extremely high specialized labor and facilities (2).

The most biological manufacturing capacity is allocated in North America and Europe. South America represents only 2.19% of world biopharmaceutical manufacturing capacity (3). It helps to explain the low number of biopharmaceutical products launched through full Brazilian research (4). The low manufacturing capacity also implies in a high cost of healthcare expenditures by Brazilian government, what reached 1.3 billion USD in 2015 (5).  

Other reasons for this outlook are the need for pilot-scale facilities and training in the bioprocess industrial environment. Pilot-scale facilities are essential for the risk-reduction process of projects, which present challenges not found in laboratory-scale studies. Moreover, the lack of suitable bioprocess infrastructure for training prevents graduates to fill key industrial positions, such as those involved in cell culture and fermentation, downstream processes, analytical development, scale-up, and regulatory affairs (6).

Despite the biopharmaceutical scenario appearing to be gloomy and discouraging in Brazil, the reality has been changed. Recently, the Brazilian government updated the Innovation Law, which goal is to stimulating partnerships between public research institutes and private companies. In 2021, it was launched the Brasil-Biotech Initiative, the structured actions that will contribute to the National Policy for Research, Development, and Innovation (R, D&I) in Biotechnology, in addition to creating, integrating, and strengthening governmental actions in the area, focusing on the promotion of science and innovation, and on the economic and social development. 

Moreover, one of the most important Brazilian initiatives is the Partnerships for Productive Development (PDP). Its main objective is to encourage the development of national biopharmaceutics to reduce the costs of acquiring medicines and health products that are currently imported or that represent a high cost for the Unified Health System (SUS). It is especially important for a country with more than 200 million habitants with a potential market for biosimilars.

“The integration among university, industry, and the government is essential for the development of the biotechnology area in Brazil. Only by combining this triad will we be able to reduce risks and overcome the “valley of death” between academic prototypes and commercial-scale deployment. I think we are heading in the right direction in Brazil”,

Fernando Barbosa, CEO of Biotimize.

Biotimize is an early-stage Biotechnology as a Service company with an innovative business model (BaaS). Led by entrepreneurs with solid experience in innovation, acquired in large companies such as Cristália and B2W Digital, in addition to training in the best research centers in the world (Harvard, UNESP, USP), Biotimize is on its way to being the first biological CDMO in Brazil. With a mission to transform lives through biotechnology, Biotimize enables ideas and treatments to become reality. To learn more about the company, visit:

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