Alpha Teknova, Pluristyx Announce Preparation of PluriFreeze Drug Master File for US FDA Submission

04:43 PM EDT, 10/02/2026 (MT Newswires) -- Alpha Teknova (TKNO) and Pluristyx said late Friday that Pluristyx is completing a Type II Drug Master File for the PluriFreeze cryopreservation system for submission to the US Food and Drug Administration. Alpha Teknova serves as the exclusive manufacturer and distributor of PluriFreeze in the US and Canada. The filing is intended to support drug developers using PluriFreeze in clinical development and manufacturing by allowing them to cross-reference the Drug Master File in investigational new drug applications and biologics license applications through a letter of authorization from Pluristyx, the companies said. PluriFreeze is a synthetic, animal-origin-free biopreservation system designed to protect cells during manufacturing through long-term cryopreservation.