In biotherapeutic manufacturing, mycoplasma testing plays an important role in ensuring product safety, but current methods do not always align with the speed required in modern processes. Culture-based assays, although accepted, can take several weeks to generate results. This article looks at how reverse transcription digital PCR (RT-dPCR) can be used as an alternative. The approach enables detection down to 5-10 CFU/mL and performs reliably even in complex sample matrices. When combined with automated nucleic acid extraction, it allows testing to be completed within a single working day.
Björkman et al. (Wed,) studied this question.
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