The TRL scale determines to what extent technology is suitable for implementation in a real operational environment. It is often used as a measure of the risk associated with the introduction of new technologies into existing systems and standard operating procedures. In fact, a sufficient level of TRL is a prerequisite for the successful transition of research from an idea, to a laboratory experiment and finally to a real operational application. That is, there is a significant inverse relationship between the TRL and the risks of adopting the technology: higher levels of TRL indicate lower perceived risks, and the low TRL indicates a higher level of risks (scale from 1 to 9). See the previous post about TRL.
The manufacturing status and risk assessments are part of procurement programs in a variety of ways. These evaluations, in spite of being very structured and well administered, do not use uniform ways to measure and communicate the risk and preparation of manufacturing. The MRL criteria are designed to manage manufacturing risk in procurement while increasing the capacity of technology development projects for the transition of new technology (scale 1 to 10). These criteria create a measurement scale and a vocabulary to evaluate and analyze maturity and manufacturing risk. Key areas of consideration that are particularly relevant include reproducibility, materials, processes, workforce skills and training, predictability of scheduling and cost, facility availability, and readiness.
MRL applied to biopharmaceutical manufacturing.
MRL 1 and MRL 2 correspond to the identification of basic manufacturing implications and concepts, respectively. At this stage, the main activities focus on applying and translating basic research into specific solutions; understanding feasibility and emerging risks; and defining materials and process approaches. Producibility assessments commence and key design characteristics are identified. MRL corresponds to the research level of the technology readiness scale (TRL 1–4).
As we face proof-of-concept manufacturing development (MRL 3), the main activities are limited to validating manufacturing concepts through analytical or lab experiments; materials and processes are characterized and defined. Although prototypes may have been developed, further demonstrations are required to set initial manufacturing cost projections and supply chain requirements (TRL 5).
MRL 4–7 occurs after proof-of-concept studies have been completed.
Capability to produce the technology in a laboratory environment (e.g. GLP) corresponds to MRL 4. Manufacturing feasibility and producibility of key concepts are assessed, and key processes and prototype manufacturing risks are identified. The next manufacturing level (MRL 5) starts with the capability to produce technology components in a production-relevant environment (e.g. elements of GMP). Although the technology level is relatively high (TRL 7), the manufacturing process is still identifying critical components to build a cost model.
At MRL 6, we are able to produce a whole technology system in a production-relevant environment (e.g. elements of GMP). An initial manufacturing approach is developed after completing cost analysis. MRL 7 starts with technologies at TRL 9, the full capability to produce technology in a production-representative environment (e.g. GMP), and supply chain management is in place for ongoing producibility improvement (production personnel, materials, equipment, processes, work instructions, cleanliness, etc.).
At MRL 10, manufacturing is controlled to a high-quality level.
MRL 8 is reached as pilot capability is demonstrated and ready to begin low-rate production in a stable supply chain. The manufacturing process is mature and all materials are ready. After low-rate production (MRL 9), where the manufacturing process is operating at target quality, cost, and performance, lean production practices are in place for full-rate production (MRL 10). All materials, manufacturing processes and procedures, inspection and test equipment are in production and controlled to Six Sigma or another appropriate quality level.
The TRL:MRL pair is usually combined as a more accurate measure of the maturity of technological projects. For example, an evaluation with a result of «7:5» indicates that the project is currently facing Phase 3 clinical trials (TRL 7) and is (or can be) in the first phase of GMP production (MRL 5).
Other innovation risk assessment markers
Along with TRL and MRL, other innovation risk assessment markers can be used. These include the Investment Readiness Level (IRL 1–9), a scale similar to TRL to define the suitability and inherent risks of the investment, and Market Maturity Level (MML 1–4) to define the maturity of the target market. Other risk markers related to innovation can be expressed at the component integration level, such as Integration Readiness Level (IRL 1–7), or at the level of the entire system, System Readiness Assessment Level (SRA 1–5). However, these scales are not standardized or as international as TRL or MRL, and generally depend on the vision of each department or company to define their scope.