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Alpha Teknova announced that its partner Pluristyx is completing a Type II FDA Drug Master File for the PluriFreeze cryopreservation system. This filing will allow developers to cross-reference the DMF in their Investigational New Drug (IND) and Biologics License Application (BLA) filings.
Teknova (NASDAQ:TKNO) and Pluristyx announced they have filed a Drug Master File for the PluriFreeze™ Cryopreservation System with the FDA. Developers of advanced therapies can use the Drug Master File in their FDA submissions.
Teknova and Pluristyx said they announced an FDA Drug Master File for the PluriFreeze cryopreservation system.