Teknova, Pluristyx complete FDA Type II DMF for PluriFreeze cryopreservation system
TKNO•Teknova and Pluristyx completed an FDA Type II Drug Master File for the PluriFreeze cryopreservation system used in cell-therapy manufacturing. The filing is intended to support drugmakers seeking to cross-reference it in IND and BLA submissions.
1. DMF for PluriFreeze
Pluristyx is completing a Type II FDA Drug Master File for its PluriFreeze cryopreservation system, which is used in cell-therapy manufacturing. Alpha Teknova is the exclusive manufacturer and distributor of PluriFreeze in the United States and Canada.
