Teknova and Pluristyx Announce FDA Drug Master File for the PluriFreeze™ Cryopreservation System
Key Highlights
- ➤FDA Type II DMF being completed for PluriFreeze™ cryopreservation system
- ➤Developers can cross-reference PluriFreeze DMF in IND and BLA applications
- ➤Teknova (TKNO) exclusive U.S. and Canada manufacturer and distributor
- ➤PluriFreeze products available for research use and GMP manufacturing applications
Expert Statements
Stephen Gunstream, President and Chief Executive Officer of Teknova
“The PluriFreeze DMF gives advanced therapy developers more to build on than strong product performance: a documented regulatory position for their cryopreservation system, ready when they need it.”
Stephen Gunstream, President and Chief Executive Officer of Teknova
“As the cell therapy industry has matured, and as more novel therapies move into clinical trials, our customers want to know that the reagents they’ve built their processes around can support them through clinical development and into commercialization.”
Stephen Gunstream, President and Chief Executive Officer of Teknova
“This file puts that documentation on record with the FDA, so they can seamlessly scale with confidence.”
Dr. Jason Carstens, Chief Operating Officer and Co-Founder of Pluristyx
“Cryopreservation is a critical manufacturing step in cell therapy, but it is often overlooked during process development.”
Dr. Jason Carstens, Chief Operating Officer and Co-Founder of Pluristyx
“PluriFreeze was designed for both cryopreservation performance and manufacturability, with a low-viscosity formulation that is easier to handle and scale as process volumes increase.”
Dr. Jason Carstens, Chief Operating Officer and Co-Founder of Pluristyx
“That focus on low viscosity and manufacturing scalability is an important point of differentiation from other cryopreservation media, and the DMF now provides the regulatory documentation to support its use as programs advance toward the clinic.”
HOLLISTER, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), and Pluristyx, Inc. (“Pluristyx”), today announced that Pluristyx is completing a Type II Drug Master File (DMF) for the PluriFreeze™ cryopreservation system for submission to the U.S. Food and Drug Administration (FDA). The DMF will support drug makers seeking to incorporate PluriFreeze into their clinical development and manufacturing programs. Teknova is a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, and is the exclusive manufacturer and distributor of PluriFreeze in the United States and Canada. Pluristyx is a leading provider of advanced induced pluripotent stem cell (iPSC) technologies and proprietary, genetically engineered solutions for drug discovery and the development of advanced therapies.
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