Regulatory considerations & validation strategies for mycoplasma testing for cell-based therapies

Cell & Gene Therapy Insights 2023; 9(8), 1053–1063


Published: 14 September 2023
Innovator Insight
Michael Brewer

The chimeric antigen receptor (CAR)-T manufacturing and quality control workflow incorporates several components including cell isolation, cell selection, genetic modification, cell expansion, cell line authentication, identity and purity testing, potency testing, and microbiological testing. Regulatory guidance exists across the workflow; at the microbiological testing stage, mycoplasma detection is particularly important. Mycoplasma testing is typically performed after the cell expansion phase of the CAR-T manufacturing process, although additional testing points may be added based on process-specific risk assessment. In this article, the current regulatory guidance regarding mycoplasma testing for cell-based therapeutic manufacturing will be discussed alongside the principles and performance of rapid, qPCR-based assays. An example of a validation study design will also be presented followed by a review and discussion of results obtained from a study executed per current regulatory expectations.