Addressing regulatory hurdles for individualized mRNA cancer immunotherapies: insights into the MHRA’s new guidance for developers

“...there are two parts to the guidance—product design, and follow on product manufacture."

In this interview Róisin McGuigan, Commissioning Editor, Nucleic Acid Insights, speaks to Francis Galaway, Quality Assessor, MHRA, about the MHRA’s newly published guidance on individualized mRNA cancer immunotherapies, along with recent advances and regulatory challenges in the space. They also discuss the role of innovative technologies, such as machine learning (ML), AI, and bioinformatics in supporting the development of personalized mRNA-based treatments.

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