Biotherapies, and especially cell therapy products, are required to be tested for sterility and mycoplasma. Developing an analytical strategy to test for sterility and mycoplasma can be daunting. There are many variables to consider, including complex matrices with high mammalian cell density and detection of non-viable microbes. Which type of analytical testing can work in an early stage of therapeutic development and then be scaled to meet the challenges later in the production process?Leveraging rapid sterility as well as mycoplasma qPCR-based detection techniques can help provide confidence in the final product by helping to detect potential contamination earlier in the production process.
Sandi True (Thu,) studied this question.