Uma proposta de níveis de maturidade baseado no TRL para tecnologias imunobiológicas

Abstract

The aim of this study was to propose a scale of technological maturity levels based on the TRL (Technology Readiness Level) metric that could guide efforts to develop immunobiological technologies beyond the phase of basic research into the development phase. This would include not only technical aspects but also dimensions of managerial and regulatory maturity. More specifically, the paper set out to study the characteristics of basic research and development within universities, institutes of science and technology (ICT) and industries. For the study, strategic aspects of the global and national pharmaceutical industry were reviewed regarding innovation, market, public policies and demands of society. Other aspects studied were product development processes (PDP) and measurement of technological maturity. Thereafter, a preliminary theoretical framework based on the metric TRL model was adapted to immunobiological technologies, with definitions of maturity measurements for the research and development phases, relative to levels one to nine of the TRL methodology. Given this scenario, a questionnaire was prepared and applied to specialists representing different agents of the innovation system in Brazil. The field study reinforced that basic research and immunobiological development projects lack maturity requirements. Finally, the study proposed a TRL model to guide the construction of research and development projects to increase probability to surpass project development phases resulting in a viable product.