Launching a CDMO in Brazil aiming to develop biopharmaceuticals for clinical trials
J. venom. anim. toxins incl. trop. dis
;
28: e20220017, 2022. graf
Artigo
em Inglês
| LILACS, VETINDEX
| ID: biblio-1386130
ABSTRACT
The innovation timeline is expensive, risky, competitive, time-consuming, and labor-intensive. 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.(AU)
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Produtos Biológicos
/
Proposta de Concorrência
/
Protocolo de Ensaio Clínico
País/Região como assunto:
América do Sul
/
Brasil
Idioma:
Inglês
Revista:
J. venom. anim. toxins incl. trop. dis
Ano de publicação:
2022
Tipo de documento:
Artigo
Instituição/País de afiliação:
Federal University of Rio de Janeiro/BR
/
São Paulo State University/BR
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