Risk Assessment for a Rapid Mycoplasma Test Optimized for Cell Therapy Products

Risk assessment is a valuable tool for selection and optimization of rapid mycoplasma testing methods. Mycoplasma testing is a requirement at various stages in the production process for cell therapy products. Standard methods take at least 28 days and are not appropriate lot release tests for products with short shelf-lives. A review of 21 commercially available mycoplasma tests and ranking of critical risk attributes resulted in the selection of 4 methods for further evaluation. A formal risk assessment process using Failure Mode Effects Analysis (FMEA) identified areas of uncertainty in routine lot release testing. The evaluation of risk to the safety of cell therapy and tissue-engineered products should rely upon scientific knowledge and ultimately link to the protection of the patient [1].