Country: Brazil

Instituto Butantan is a century-old Brazilian institution focused on the research and development of biological medicines for public health. Currently, the institution is responsible for providing 65% of all vaccines and 100% of the antivenoms and antitoxins distributed by the public health system in Brazil. Regarding the production of vaccines, there are eight products supplied to the Ministry of Health, whose current production capacity is the result of internal development of processes for obtaining vaccine antigens, in addition to technology transfer and Productive Development Partnerships (PDPs) between Butantan and external laboratories. Besides the vaccines against hepatitis A and B, rabies, DTaP and HPV, Butantan supplies the trivalent seasonal influenza vaccine. In 2022, Butantan delivered 80 million doses of this vaccine, and in 2021, the institution was certified by the WHO for the supply of the trivalent seasonal influenza vaccine to other countries in need, through the Pan American Health Organization (PAHO, a branch of the WHO). According to the latest Global Vaccine Market Report released by the WHO in November 2022, the institute has reached the ranking of the top 10 vaccine manufacturers in the world. The Bioindustrial Center of Instituto Butantan, located in São Paulo – Brazil, is composed of facilities that operate under strict biosafety standards and good manufacturing practices (GMP certification). These facilities are prepared to work with different technological platforms, such as virus infection in mammalian cells and in embryonated eggs, from bench scale to industrial level for commercial production. In addition, this manufacturing center has installed capacity to formulate, fill and package about 100 million doses with the prospect of 250 million doses of vaccine per year. There is also a lyophilization plant that is part of the formulation and packaging capacity. Recently, we have also launched a new plant to produce monoclonal antibodies, equipped for cell culture in single-use technology, with a capacity of up to 2000 liters in a bioreactor. This plant is designed to produce six different biosimilar monoclonal antibodies for therapeutic purposes, high-cost drugs used for cancer immunotherapy and autoimmune and chronic degenerative diseases. Instituto Butantan is also highly committed to rapid response to public health problems. During the COVID-19 pandemic, the institution promptly established strategies to combat the spread of the SARS-CoV-2 virus. The partnership with Sinovac Biotech Ltd enabled us to produce more than 120 million doses of the vaccine that were delivered by the National Immunization Program (NIP), for immunization of adults and children in Brazil. Instituto Butantan is also developing a new vaccine of chimeric Newcastle Disease Virus (inactivated), the Butanvac. This vaccine is under development by Instituto Butantan, together with the Icahn School of Medicine at Mount Sinai in the United States, the Government Pharmaceutical Organization of Thailand, the Institute of Vaccines and Medical Biologicals in Vietnam and the University of Texas at Austin, within a consortium led by PATH. Butantan was also responsible for coordinating a surveillance network and detection of new variants of SARS-CoV-2 in the state of São Paulo, a fundamental action for the direction of public policies to mitigate epidemics/pandemics. Besides its industrial capacity being focused directly on responding quickly to the population’s challenges, Instituto Butantan is one of the largest research centers in the world and is responsible for great influence on national and international academic research. The institution is responsible for developing basic research and an interface with applied research. For research and development activities, there are 150 researchers, 25 laboratories and 132 research lines. Butantan also relies on a team of 3000 employees of Fundação Butantan (a private non-profit institution that supports the institute), working in different areas, such as administrative, bioindustrial and research. | Instituto Butantan is a century-old Brazilian institution (founded in 1901) focused on the research and development of biological medicines for public health. The institution is responsible for supplying 65% of all vaccines and 100% of antivenoms and antitoxins distributed by the public health system in Brazil. Over the last five years, as well as in previous years, the institute has provided the Ministry of Health with eight products. In addition to vaccines for Hepatitis A and B, rabies, DTPa, and HPV, Butantan supplies the trivalent vaccine for seasonal influenza. In 2023, Butantan delivered 80 million doses of this vaccine, and in 2021, the institution was certified by the WHO to supply the trivalent vaccine for seasonal influenza to other countries in need, through the Pan American Health Organization (PAHO, a branch of the WHO). According to the latest Global Vaccine Market Report published by the WHO in November 2022, the institute ranked among the top 10 vaccine manufacturers in the world by revenue. Recently, we also launched a new plant for monoclonal antibody production, equipped for cell culture using single-use technology, with a capacity of up to 2,000 liters in a bioreactor. This plant was designed to produce six different biosimilar monoclonal antibodies for therapeutic purposes—high-cost medicines used for immunotherapy against cancer and chronic autoimmune and degenerative diseases. Instituto Butantan is also highly committed to a rapid response to public health issues. In the clinical development scenario over the past five years, Butantan has conducted clinical studies for COVID-19 (Phase 3 and Phase 4 studies), influenza (Phase 3 studies), Chikungunya (Phase 3 studies), and Dengue (Phase 2 and Phase 3 studies). The development of a dengue vaccine has been a major achievement in recent years, addressing a significant unmet medical need in Brazil, where dengue is endemic. In addition to its industrial capacity, the Institute exerts significant influence on national and international academic research, being responsible for developing basic research and bridging it with applied research. For research and development activities, there are 150 researchers, 25 laboratories, and 132 research lines. Butantan also has a team of 3,000 employees from the Butantan Foundation (a non-profit private institution that supports the institute), working in various areas such as administration, bioindustry, and research. Instituto Butantan has established itself as an independent sector, with the capacity to respond with agility and sovereignty to specific population challenges, such as the need to confront the pandemic caused by the SARS-CoV-2 virus, with impacts on health, social, and economic areas.