Gavo-cel manufacturing, LD and bridging therapy
STERILE, SEPARATION
PBMCs were collected via leukapheresis using standardized procedures and cryopreserved following a controlled-rate freezing process. Manufacturing of a gavo-cel product was started a median of 11 d after leukapheresis (one product was started 260 d after leukapheresis collection due to the need to remanufacture after the initial product bag was found to be damaged). The manufacture of the gavo-cel product was carried out using the functionally closed CliniMACS Prodigy automated cell processing system at the Miltenyi Biotec manufacturing facility in San Jose, California. There, the apheresis blood product was attached to the CliniMACS Prodigy system through a sterile weld. After separation by Ficoll-Paque density gradient centrifugation, CD4