Teknova and Pluristyx file FDA Drug Master File for PluriFreeze

The cryopreservation system's Type II DMF lets cell therapy developers cross-reference regulatory documentation in IND and BLA submissions.

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A line of bright, silver cylindrical machines with glass doors and glowing blue interiors stands in a sterile, white clean room with additional lab equipment in the blurred background.

Alpha Teknova and Pluristyx have announced that Pluristyx is completing a Type II Drug Master File (DMF) for the PluriFreeze cryopreservation system, with submission to the US Food and Drug Administration imminent. The filing means that cell and gene therapy developers who have already adopted PluriFreeze in preclinical work can now request a letter of authorisation from Pluristyx and cross-reference the DMF directly in Investigational New Drug applications and Biologics Licence Applications, removing a documentation burden that has historically slowed the transition from research-grade to GMP-grade reagent use.

Teknova, listed on Nasdaq as TKNO and headquartered in Hollister, California, became the exclusive manufacturer and distributor of PluriFreeze in the United States and Canada following a partnership with Pluristyx announced in March 2025. That arrangement gave Teknova responsibility for manufacturing and quality content, which now underpins the regulatory file. PluriFreeze products are manufactured at Teknova's ISO 13485 certified facilities on the same modular platform the company uses across its broader reagent portfolio.

What the system does

PluriFreeze is a synthetic, animal-origin-free biopreservation system comprising two products. PluriFreeze Base is a cellular wash formulated to mimic intracellular space and provide metabolic support across the manufacturing workflow. PluriFreeze PF10 is a low-viscosity freezing medium containing 10% dimethyl sulfoxide (DMSO), designed to simplify scale-up and process automation. Both are available for research use and GMP manufacturing applications and are stable for up to two years at 2-8 degrees Celsius.

In comparative studies cited in the release, PluriFreeze PF10 delivered post-thaw viability, recovery, doubling times, expansion, and surface marker expression similar to an unnamed industry reference product across multiple pluripotent stem cell lines and Natural Killer cell types.

Stephen Gunstream, Teknova's president and chief executive, said the DMF gives therapy developers "a documented regulatory position for their cryopreservation system, ready when they need it," adding that customers scaling toward commercialisation want confidence that their established reagents can travel with them through the regulatory process. Jason Carstens, Pluristyx's chief operating officer and co-founder, highlighted low viscosity as a key differentiator, arguing that it simplifies handling as process volumes increase.

Market context

Cryopreservation media is a relatively fragmented but strategically important segment within cell therapy bioprocessing. As the number of cell and gene therapy programmes in clinical development continues to expand, scrutiny of ancillary materials and their regulatory documentation is increasing. Regulators on both sides of the Atlantic have signalled through guidance updates that CMC sections of IND and BLA filings must address cryopreservation methodology with increasing specificity, particularly for allogeneic, off-the-shelf products where centralised manufacturing and cold-chain integrity are integral to the product's quality profile.

Several larger life-science tooling companies, including Cytiva, Thermo Fisher Scientific, and BioLife Solutions, also compete in the cryopreservation media market with products aimed at GMP cell therapy workflows. A filed DMF providing ready-made regulatory cross-referencing capability represents a meaningful differentiator for smaller, specialist suppliers, reducing the compliance overhead for therapy developers who would otherwise need to generate and hold their own supplier documentation packages.

For Teknova, the move reinforces a broader positioning as a GMP-grade reagent supplier capable of supporting customers through the full development lifecycle, from discovery to commercialisation. Near-term milestones to watch include formal FDA acknowledgement of the DMF submission and the first disclosed IND or BLA cross-references by named therapeutic developers.

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