Demonstrates improved mycoplasma detection in biotherapeutics, implying safer manufacturing processes.
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.
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Björkman et al. (2026) studied this question.
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