Kymriah GMP issues in NJ led to FDA letter for Novartis—Is gene therapy on its last legs?

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Kymriah GMP issues in NJ led to FDA letter for Novartis

This is potentially a watershed event:

The US FDA has highlighted GMP deficiencies in the production of CAR-T therapy Kymriah at Novartis’ Morris Plains plant.

In November and December last year, the United States Food and Drug Administration (FDA) inspected the Morris Plains, New Jersey facility, resulting in it issuing a Form 483 [inspection report] with an undisclosed number of observations to Novartis. This is an extract:

Among the deviations, the Agency found Novartis failed to establish laboratory controls, particularly citing sampling plan and test procedure issues relating to freezing bags – or ‘Cryobags’ – the primary container for Kymriah.

“[The plans] are not appropriate to assure that Cryobags are “free of…particulate matter” as required by your acceptance criteria,” the Agency states. “Between December 2018 and the date of the inspection, you identified approximately 100 batches of Kymriah contaminated with foreign particulate matter, such as wood, cellulose, brass, and steel.