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

Cell therapy 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. At the microbiological testing stage, mycoplasma detection is particularly important in line with regulatory guidance. In this poster, current regulatory expectations for mycoplasma testing are discussed, followed by review of a sample validation study design and analysis.