Proposing a Local “Technology Readiness Assessment” Model for Biopharmaceutical Industries of Iran

Abstract

Background: Reliable assessment of innovative technology readiness is crucial for industrial decision-making. Technology Readiness Assessment (TRA) is an established tool used to qualify technology development and help make investment decisions and deploy systems or technology elements to an end-user in a timely fashion. “Manufacturing readiness levels” (MRLs) and “ATLAS technology method” (technology components evaluation) metrics are commonly employed in TRA to assess the impact of technologies for future R&D programs and development of manufacturing and risk of a given technology, system, and or subsystem. Methods: In this study, E.coli-based recombinants were chosen as the objective. Two questionnaires were designed on their manufacturing process and sent to 13 biopharmaceutical experts in Iran. Results: The findings show that Iranian biopharmaceutical experts validated the proposed MRLs model inspired by the US Department of Defense’s published questionnaire. To run the “ATLAS technology method”, the relative importance of technology components (software, hardware, and human resources) involved in each stage of manufacturing and each stage’s relative importance was determined by experts in the percentage scale. Conclusion: Policymakers and managers must have enough knowledge of how to evaluate manufacturers’ abilities, and in this way, TRA is a usable and exquisite tool. In this article, two TRA methods that appear compatible with Iran’s environment of the biopharmaceutical sector are proposed.

Keywords

• Readiness Assessment
• Biopharmaceutical of Iran
• Manufacturing Readiness Levels
• Technology Components
• E.coli Based Recombinants