Good management practices of venomous snakes in captivity to produce biological venom-based medicines: achieving replicability and contributing to pharmaceutical industry.

One of the factors responsible for lack of reproducible findings may be attributed to the raw material used. To date, there are no apparent studies examining reproducibility using venoms for the development of new toxin-based drugs with respect to regulatory agencies' policies. For this reason, protocols were implemented to produce animal toxins with quality, traceability, and strict compliance with Good Manufacturing Practices. This required validation of the production chain from the arrival of the animal to the vivarium, followed by handling, housing, as well as compliance with respect to extraction, freeze-drying, and, finally, storage protocols, aimed at generating compounds to serve as candidate molecules applicable in clinical trials. Currently, to produce quality snake venoms to support reproductive studies, the Center for the Study of Venoms and Venomous Animals (CEVAP) from São Paulo State University (UNESP), São Paulo, Brazil has 449 microchipped snakes through rigid and standardized operating procedures for safety, health, and welfare of animals. Snakes were frequently subjected to vet clinical examination, anthelmintic, and antiparasitic treatment. Venom milk used to destroy prey was collected from each animal in individual plastic microtubes to avoid contamination and for traceability. In addition, venoms were submitted to microbiological, and biochemical toxicological analyses. It is noteworthy that investigators are responsible for caring, maintaining, and manipulating snakes and ensuring their health in captivity. This review aimed to contribute to the pharmaceutical industry the experimental experience and entire snake venom production chain required to generate quality products for therapeutic human consumption.

Gestión del desarrollo de productos en el Centro de Inmunología Molecular / Product development management at Molecular Immunology Center

El crecimiento de las empresas en un mundo altamente competitivo depende del rendimiento superior del proceso de desarrollo de sus productos. Estudios anteriores mostraron que hoy la dificultad principal del crecimiento del Centro de Inmunología Molecular está en la capacidad de penetrar los mercados de exportación, y el desarrollo de nuevos productos. La implementación de un sistema de gestión de desarrollo de productos a partir del diagnóstico de las limitaciones actuales permitirá eliminar las restricciones en el desarrollo de nuevos productos y constituirá una herramienta para el éxito de la realización de los mismos de manera competitiva. En este artículo se caracteriza la gestión de desarrollo de productos en el Centro de Inmunología Molecular, a partir de la realización de encuestas y tormentas de ideas y se propone un sistema de gestión para el desarrollo de productos en la institución que permita su uso como herramienta para su competitiva realización(AU)

The growth of companies in a highly competitive world depends on the superior performance of the development process of their products. Previous studies showed that today the main difficulty of the Molecular Immunology Center growth resides in the ability to enter international markets, and in the development of new products. The implementation of a product development management system based on the diagnosis of the current limitations will eliminate the restrictions and will be a tool for successfully implementing competitive products at the center. The product development management in the Center of Molecular Immunology is characterized in this paper starting from surveys and brainstorming results; and a product development management system is proposed to the institution as a tool to create a sustainable competitive advantage for the new products(AU)