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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