FROM BENCH SCALE TO PILOT PLANT OPERATION: BUSINESS MODELS AND CHALLENGES IN THE BIOPHARMACEUTICAL INDUSTRY IN BRAZIL

摘要

Brazil has several challenges to strengthen the biopharmaceutical industry, one of them particularly regarding the ability to translate scientific research into products. Many scholars have been working on this issue and the causalities involved on it in order to contribute to a better understanding of interrelationship between micro and macroeconomic dynamics. Most of the studies are directed to private organizations based in developed countries and aimed to understand the factors of success. Despite the wealth of these approaches, there are few studies about the challenges involved in the transitions from preclinical to clinical stage in the process of Research and Development in developing countries. There are gaps in the understanding of these steps, especially with respect to the requirement to move from the bench to the pilot scale. The main objective of a pilot plant in the biopharmaceutical industry is to demonstrate, with scientific and technological data, the feasibility of a candidate product being transformed into a pilot batch in a GMP certified area. For that, it is necessary to obtain data on yield, reproducibility, repeatability of the established processes, physicochemical stability and thermal stability of the candidate antigen or molecule, formulation parameters and process scheduling. In view of this fact, the present work addresses the issue of industrial pilot plants areas in developing countries from the application of business models approach. The literature about business models provide a practical reference able to assist other organizations to outline the value proposition and to analyze the critical factors for success implementation of pilot plants. This work aims to contribute to the discussion of this topic in Brazil due to the ongoing initiatives for the implementation of pilot plants and to serve as subsidies for public policy. Considering the scenario of the biopharmaceutical industries, where the dynamics of biotechnological and economic transformations has been shown to be complex for the evolution of the product development cycle, Brazil needs not only to improve its infrastructure for Research and Development but also to design and implement appropriate business models for the components of this infrastructure.