Next, Miguel Nogueras, Abbott, discussed the use of rapid methods for Mycoplasma detection. He described the current 28-day assay and how faster testing is required for products with short half-lives (e.g., autologous and tissue based products), raw materials, release testing, process development testing, cell line or virus sock qualification and contamination monitoring. A variety of RMM techniques were described, including nucleic acid amplification, immunological tests, enzyme based methods, and hybridization methods without the need for nucleic acid amplification. He then described Abbott’s strategy for validating a RMM using the following parameters: interference, specificity, detection limit, precision, reproducibility, robustness, system suitability and comparability. The latter established a relationship between the RMM and existing method unit of measurement (e.g., genomic copies, protein or enzyme vs. CFU). Finally, Miguel discussed their strategy for validation and implementation, which included design planning, input, output, verification, validation and transfer. During these phases they were actively engaging the regulatory authorities.