КОМПЛЕКСНАЯ ОЦЕНКА ПРОИЗВОДСТВЕННОЙ ГОТОВНОСТИ ПРОЕКТА ПОЛНОГО ЦИКЛА РАЗРАБОТКИ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА

Abstract

Currently, there is still a large gap between developed technology and production capabilities that translate this technology into commercial success. In this case, there is an inability to "bridge the gap", i.e. incomprehension of how to advance product development from a laboratory sample to serial production of this product. Definition of the research and development life cycle on the basis of stages, differentiated according to the technology readiness levels and manufacturing readiness levels, taking into account the experience of applying various techniques in world practice, and also on the basis of determining the level of technology readiness, was first outlined in the Guidelines for the preparation of initial data for the development and correction of forecast of scientific and technological development of the Russian Federation, approved by the Order of the Ministry of Education and Science of the Russian Federation No. 1335 dated 11/13/2015. A prerequisite for implementation of state-funded research and development programs was the need to evaluate the TRL and MRL at the time of launch and on completion of research project. Currently, in the Russian Federation, the use of TRL-assessments is provided for by the Order of the Ministry of Education and Science of the Russian Federation No. 107 dated 02/06/2023 "On Approval of the procedure for determining the readiness levels of emerging or developed technologies, as well as scientific and scientific-technical results corresponding to each technology readiness level". TRL assessment, which is characterized by the readiness of the drug product production from the design of molecule to the commercial batch production, is currently not used in the field of drug circulation.