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

Registro completo de metadados
MetadadosDescriçãoIdioma
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorUniversidade Federal do Rio de Janeiro (UFRJ)-
Autor(es): dc.contributorMinistry of Science Technology and Innovation (MCTI)-
Autor(es): dc.creatorFerreira Junior, Rui Seabra-
Autor(es): dc.creatorMorales, Marcelo Marcos-
Autor(es): dc.creatorBarretti, Pasqual-
Autor(es): dc.creatorBarraviera, Benedito-
Data de aceite: dc.date.accessioned2025-08-21T17:59:05Z-
Data de disponibilização: dc.date.available2025-08-21T17:59:05Z-
Data de envio: dc.date.issued2023-03-01-
Data de envio: dc.date.issued2023-03-01-
Data de envio: dc.date.issued2021-12-31-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1590/1678-9199-JVATITD-2022-0017-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/241225-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/241225-
Descrição: dc.descriptionThe 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.-
Descrição: dc.descriptionFundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)-
Descrição: dc.descriptionCenter for the Study of Venoms and Venomous Animals (CEVAP) São Paulo State University (UNESP), SP-
Descrição: dc.descriptionDepartment of Tropical Diseases and Diagnostic Imaging Botucatu Medical School (FMB) São Paulo State University (UNESP), SP-
Descrição: dc.descriptionCarlos Chagas Filho Institute of Biophysics Federal University of Rio de Janeiro (UFRJ), RJ-
Descrição: dc.descriptionSecretariat of Research and Scientific Training Ministry of Science Technology and Innovation (MCTI), DF-
Descrição: dc.descriptionDepartment of Internal Medicine Botucatu Medical School (FMB) São Paulo State University (UNESP), SP-
Descrição: dc.descriptionSão Paulo State University (UNESP), SP-
Descrição: dc.descriptionCenter for the Study of Venoms and Venomous Animals (CEVAP) São Paulo State University (UNESP), SP-
Descrição: dc.descriptionDepartment of Tropical Diseases and Diagnostic Imaging Botucatu Medical School (FMB) São Paulo State University (UNESP), SP-
Descrição: dc.descriptionDepartment of Internal Medicine Botucatu Medical School (FMB) São Paulo State University (UNESP), SP-
Descrição: dc.descriptionSão Paulo State University (UNESP), SP-
Idioma: dc.languageen-
Relação: dc.relationJournal of Venomous Animals and Toxins Including Tropical Diseases-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjectBiopharmaceuticals-
Palavras-chave: dc.subjectContract development and manufacturing organizations (CDMO)-
Palavras-chave: dc.subjectGood manufacturing practices (GMP)-
Palavras-chave: dc.subjectTranslational research Clinical trials-
Título: dc.titleLaunching a CDMO in Brazil aiming to develop biopharmaceuticals for clinical trials-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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