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Center of Research and Development in Immunobiologicals

Abstract

Instituto Butantan (IB), has always worked to answer public health challenges and has a long tradition in the development and manufacturing of vaccines and antibodies. This project addresses both areas, influenza vaccines and human monoclonal antibodies, focusing on critical targets that demand attention and require the use of strategies based on solid scientific, clinical, regulatory and organizational knowledge. For this demand, the multidisciplinary Center for R&D in Immunobiologics (CeRDI) is articulated between research institutions and companies with common objectives to achieve the intended goals. The communication between the partners, initiated with the Center's nucleation, revealed the enthusiasm in the construction of this proposal and the determination to seek solutions with state-of-the-art technologies. As the largest manufacturer of influenza vaccine in the southern hemisphere, Butantan has in recent years met the challenge of achieving national autonomy by increasing the productive capacity of the influenza vaccine to up to 75 million doses annually. With the creation of these core of competences, we have the opportunity to advance in innovative and non-trivial aspects to increase vaccination coverage, related to the quadrivalent vaccine, such as the adjuvant formulation and high-dose formulation. We aim also on the development of new influenza vaccines, such as a cell-culture based vaccine, and broadspectrum vaccine, the latter a globally sought for solution. On the other hand, this Center will dedicate to advancing the current development of neutralizing human monoclonal antibodies (humAbs), based on platforms established separately at Butantan and at the University of São Paulo Medical School (FMUSP), focusing on anti-tetanus toxin mAbs, anti-Zika virus (ZIKV) mAbs , antiyellow fever virus (wtYFV) mAbs and anti-influenza viruses mAbs (H7N9 and elicited by universal vaccine vaccinated people). Obtained from gene sequences of antibodies produced by memory B lymphocytes or plasmablasts, humAbs have the advantage of being selected in vivo. The platform, based on the identification of the antibody sequences through the generation of stable cell lines, will allow for the production of antibodies with therapeutic potential to control serious public health problems. CeRDI counts on partnerships between Butantan Institute/Butantan Foundation and the University of São Paulo, besides researches from the Instituto Adolfo Lutz and Oxford University. A partnership with the Universidade Municipal de São Caetano do Sul aims to create a territory of excellence in clinical effectiveness assessment tests, and to nucleate competences in the area. CeRDI counts on the participation of Bionovis SA (Brazil) and the startups Blue Waters Vaccines and Mabloc, based on USA. The conjunct action of institutions and companies, acting in complementary and competence, will allow for the improvement and development of biopharmaceutical products, a strategic and desirable condition for the immunobiologicals industry in our country. (AU)

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