Quality
The inventors view
There are often large inter- and intralaboratory variations even though the same standard protocol is used. There is a need for training activities.
The view of the end users
Companies pointed out that they have a special interest in the quality of the results obtained even while they are considering them as qualitative indicators. Since the models used in the companies are matching with their expectations, the final users are willing to obtain more relevant models with increasing relevancy about the results, a good quality of product (GMP like production and batch), the robustness of the results and reproducibility. In other words, it seems that the users have defined the strengths and limitations of the testing models they use and established a system to apply them in their R&D process.
The manufacturers view
The largest problem reported when a research method is transferred into a commercial assay is the lack of intra- and interlaboratory reproducibility.
The second largest problem is the need of common routines, SOPs, and result calculations but also to the problem of different knowledge and experience in the laboratories is important. Other problems and bottlenecks are the complexity of equipment(instruments and models/assays), the lack of clear positive and negative reference compounds, validation procedures, and the lack of correctly registered historical data (traceability of data). Training of personnel on how to use the assay/model, and the quality controls at the laboratories and production facilities need to be improved.
Comments from the Expert meeting
Reproducibility is a crucial point in technology transfer and a change in mentality within academia concerning the importance of reproducibility is badly needed. However, there are different criteria for reproducibility dependent on the application of the method, e.g. screening, hazard identification or risk assessment.
The experts representing the end users pointed out that GLP or other quality systems are an absolute must for the use of methods in commercial application. They would not work with CROs or test kits produced without GLP, GMP or any other suitable quality system. This concerns larger companies as well as SMEs. The academic scientists have to think about quality and reproducibility already at the beginning of method development.
Usually there is a need of simplifying and increasing the robustness of a new method during the development procedure. However, the academic scientists should not regard this transformation as a failure. It is also important that the end users do not inhibit the creativity during the research phase. One should also keep in mind that there are research models and test models that have to answer different questions and therefore ar not easily replaceable.
Standardisation and clear guidelines for prevalidation and validation including the writing of SOPs would certainly increase the reproducibility and facilitate the procedure of transfer. This also applies for clear criteria for the submission of new methods into the OECD process for acceptance in guidelines. Increased transparency of the process of validation and submission for the OECD process for acceptance as well as a clear timeline for the procedure are needed. If the test methods shall be available for the end users in reasonable time it is important to speed up these processes. The process works better for drug testing, since they have extensive guidelines on what is needed for the application to the Medical Authorities.
Standardisation and customers’ training as well as proper and usable SOPs should be provided by the provider/manufacturer of a test method to secure good quality.