Launching a CDMO in Brazil aiming to develop biopharmaceuticals for clinical trials

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dc.contributor.authorFerreira Junior, Rui Seabra [UNESP]
dc.contributor.authorMorales, Marcelo Marcos
dc.contributor.authorBarretti, Pasqual [UNESP]
dc.contributor.authorBarraviera, Benedito [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionUniversidade Federal do Rio de Janeiro (UFRJ)
dc.contributor.institutionMinistry of Science Technology and Innovation (MCTI)
dc.date.accessioned2023-03-01T20:52:32Z
dc.date.available2023-03-01T20:52:32Z
dc.date.issued2022-01-01
dc.description.abstractThe innovation timeline is expensive, risky, competitive, time-consuming, and laborintensive. In order to overcome such challenges and optimize financial resources, pharmaceutical companies nowadays hire contract development and manufacturing organizations (CDMO) to help them. Based on the experience acquired first from the development of two biopharmaceuticals, the Heterologous Fibrin Sealant and the Apilic Antivenom, and more recently, during their respective clinical trials; the Center for the Study of Venoms and Venomous Animals (CEVAP) proposed to the Ministry of Health the creation of the first Brazilian CDMO. This groundbreaking venture will assist in converting a candidate molecule - from its discovery, proof of concept, product development, up to pilot batch production - into a product. The CDMO impact and legacy will be immense, offering service provision to the public and private sector by producing validated samples for clinical trials and academic training on translational research for those seeking a position in pharmaceutical industries and manufacturing platforms.en
dc.description.affiliationCenter for the Study of Venoms and Venomous Animals (CEVAP) São Paulo State University (UNESP), SP
dc.description.affiliationDepartment of Tropical Diseases and Diagnostic Imaging Botucatu Medical School (FMB) São Paulo State University (UNESP), SP
dc.description.affiliationCarlos Chagas Filho Institute of Biophysics Federal University of Rio de Janeiro (UFRJ), RJ
dc.description.affiliationSecretariat of Research and Scientific Training Ministry of Science Technology and Innovation (MCTI), DF
dc.description.affiliationDepartment of Internal Medicine Botucatu Medical School (FMB) São Paulo State University (UNESP), SP
dc.description.affiliationSão Paulo State University (UNESP), SP
dc.description.affiliationUnespCenter for the Study of Venoms and Venomous Animals (CEVAP) São Paulo State University (UNESP), SP
dc.description.affiliationUnespDepartment of Tropical Diseases and Diagnostic Imaging Botucatu Medical School (FMB) São Paulo State University (UNESP), SP
dc.description.affiliationUnespDepartment of Internal Medicine Botucatu Medical School (FMB) São Paulo State University (UNESP), SP
dc.description.affiliationUnespSão Paulo State University (UNESP), SP
dc.description.sponsorshipFundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
dc.identifierhttp://dx.doi.org/10.1590/1678-9199-JVATITD-2022-0017
dc.identifier.citationJournal of Venomous Animals and Toxins Including Tropical Diseases, v. 28.
dc.identifier.doi10.1590/1678-9199-JVATITD-2022-0017
dc.identifier.issn1678-9199
dc.identifier.issn1678-9180
dc.identifier.scopus2-s2.0-85132793625
dc.identifier.urihttp://hdl.handle.net/11449/241225
dc.language.isoeng
dc.relation.ispartofJournal of Venomous Animals and Toxins Including Tropical Diseases
dc.sourceScopus
dc.subjectBiopharmaceuticals
dc.subjectContract development and manufacturing organizations (CDMO)
dc.subjectGood manufacturing practices (GMP)
dc.subjectTranslational research Clinical trials
dc.titleLaunching a CDMO in Brazil aiming to develop biopharmaceuticals for clinical trialsen
dc.typeArtigo

Arquivos

Coleções

Botucatu - CEVAP - Centro de Estudos de Venenos e Animais Peçonhentos
Artigos - Clínica Médica - FMB
Artigos - Doenças Tropicais e Diagnósticos por Imagem - FMB