Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Table 1 The potential failures, scores, and proposed mitigation approaches identified by PHA

The risk score was calculated as [Severity × Likelihood of recurrence], where Likelihood = (Occurrence × Detection), the Severity ranking was assigned based on the severity of the consequences of failure, the Occurrence ranking rates the probability of a failure occurring, and the Detection ranking indicates the chances of detecting a failure before it occurs using customized ranking scales as a guide (Additional file 1: Table S1)
SOP standard operating procedure, QC quality control, ISO International Organization for Standardization, GMP good manufacturing practice, CAPA corrective and preventive actions, GLP good laboratory practice

ISSN: 1479-5876