RE:CAR-T updateDecember 15, 2023 - The FDA has placed a clinical hold on three of CARsgen Therapeutics’ CAR-T cell therapy candidates following an inspection of the Chinese biotech’s manufacturing facility in Durham, North Carolina.
According to CARsgen, the clinical hold on its products are due to chemistry, manufacturing, and controls-related “questions” that arose due to the FDA inspection.
In a statement emailed to BioSpace, a CARsgen spokesperson said that “lingering concerns” surrounding employee training and “other legacy issues” need to be addressed for the facility to be in compliance.
https://www.biospace.com/article/fda-puts-clinical-hold-on-three-carsgen-therapeutics-car-t-candidates/