Promising mRNA tech comes with regulatory, CMC headaches
As the buzz builds around messenger RNA (mRNA) technology’s use for two leading Covid-19 candidates, manufacturers and regulatory professionals are facing facts: This is not simple technology.
Complex manufacturing processes, delivery vehicles that must be treated more as drug substances than excipients, and potential immunogenicity headaches are among the challenges industry faces as this promising technology is harnessed to address an increasing number of health conditions.
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