An index of a technology’s readiness for commercialization has been developed by CBiRC based on the technology readiness level (TRL) system developed by NASA and used since by a wide variety of agencies and industries. The TRL scale aligns with CBiRC’s experiences of scale and technology maturity based on working with and being advised by multiple industry members. TRL 1 and TRL 2 are the experimental research stages that lead to the conceptualization of an idea that might be formulated into a production system. TRL levels 1 and 2 are the standard realm of academic bioprocess development.
It is in TRL 3 that CBiRC achieves the experimental lab scale Proof of Concept that includes conceptualizing the system design. TRL 3 marks the beginning of CBiRC’s “sweet spot” as an ERC, in which research is transitioned beyond the usual academic realms. This “CBiRC sweet spot” extends through TRL 4 of technology development and involves small scale technology validation in the laboratory at 1-10 liter scale. At this stage there is sufficient knowledge to combine and integrate the technologies into a system that can be termed a Testbed design which is accompanied by a detailed engineering process design. The progression to process design during TRL 4 begins with a process flow diagram, which enables CBiRC to visualize the overall system. This stepwise staging process allows for the development of a disciplined, effective and metric-driven process for technology derisking and scaling.
Shown below is a table of TRL stages populated with metrics that act as ranges used for managing process development and advancement between stages. The metrics in TRL 3 mark the performance levels required to achieve Proof of Concept and advance from lab scale to small process scale. The metrics in TRL 4 mark the performance levels required to achieve system integration and advance to pre-pilot scale. The metrics in TRL 5 mark the performance levels required to achieve system enhancement and advancement to pilot scale.