The Quality Lowdown: Moderna, Novartis, Dr. Reddys Confront Challenges

Leading edge products like mRNA vaccines and CAR-T therapies are not immune from quality problems, nor are immunosuppressives, as US FDA inspections and internal investigations recently found.

The Quality Lowdown

A combination of design issues and procedural lapses led one firm to release drug substance batches for its mRNA COVID-19 vaccine despite concerning levels of microbiological contamination and the use of expired materials.

Another firm struggled with particulate contamination of the cryopreservation bags for its autologous

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