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PluriFreeze for Cellular Starting Materials

Protection begins at collection

Each collection is one of a kind. The PluriFreeze™ cryopreservation system protects your cells from the moment of collection, through processing, cryopreservation, and transport, so the product you collect keeps its viability and function all the way to the point of use.

PluriFreeze Cryopreservation System

Protection that holds

72 hours

Up to three days of supported hold in PluriFreeze Base at 2–8°C, enough to cover overnight storage before next-day processing.

9 components

Fewer components means less to assess in qualification, and every one is listed in the US FDA’s Inactive Ingredient Database. PluriFreeze Base has 8 components, and PluriFreeze PF10 adds DMSO as the ninth.

DMF available

A Type II Drug Master File is held by Pluristyx, with a Letter of Authorization available to cross-reference in your IND or BLA.

WHO IT'S FOR

Built for teams who handle
irreplaceable material

Whether you bank cord blood, process apheresis products, or supply leukopaks and tissue, the viability of your starting material depends on how it’s held between collection and cryopreservation.

Cord blood banks

Cord blood units are cryopreserved within 48 hours of collection, often after a long courier leg. PluriFreeze Base supports the volume-reduced unit through in-process testing, and PluriFreeze PF10 carries it through the controlled-rate freeze.

Cell processors

 

Apheresis products are often held overnight before next-day processing, with DMSO exposure kept short at the freeze. PluriFreeze Base supports cells through the overnight hold at 2–8°C, and PluriFreeze PF10 goes in only when you’re ready to freeze.

Leukopak and tissue suppliers

Fresh leukopaks and tissue, from biopsies for stromal cell isolation to skin samples for iPSC reprogramming, often travel overnight before processing. PluriFreeze Base supports cells and tissue in transit, and PluriFreeze PF10 freezes isolated cells when you supply them cryopreserved.

Developed by cell therapy experts

The PluriFreeze cryopreservation system was developed by Pluristyx, a leading provider of induced pluripotent stem cells for next-generation cell therapies, and is manufactured by Teknova in its state-of-the-art facilities under its ISO 13485 certified QMS. It is exclusively available from Teknova in the United States and Canada.

Pluristyx logo

FOR USE ACROSS YOUR WORKFLOW

Protection from

minute one

From the overnight hold to post-thaw processing, PluriFreeze Base supports cells on either side of the freeze, and PluriFreeze PF10 carries them through it.

Cryopreservation workflow diagram showing when to use the PluriFreeze Base and PF10

Suspend cells in cold PluriFreeze Base for holds of up to 72 hours at 2–8°C during collection, transport, and in-process testing. Its buffered, hyperosmotic formulation provides osmotic support, with mitochondrial support compounds that protect cells from hypothermic stress.

After volume reduction, wash or resuspend the cell fraction in PluriFreeze Base to remove residual plasma, culture media, and processing solutions. The wash introduces cells to the salts and sugars that support reduced metabolism at hypothermic temperatures, limits swelling, and brings cells to a known concentration for downstream processing.

Add PluriFreeze PF10 cold and slowly to reach your target final DMSO concentration, or dilute it with PluriFreeze Base for concentrations below 10%. Because PluriFreeze Base is the same formulation as PluriFreeze PF10 without DMSO, cells enter cryopreservation in a consistent chemical environment.

Run your existing controlled-rate program, since the melting point and glass transition temperature align with the industry standard by differential scanning calorimetry. Store in vapor-phase liquid nitrogen below –135°C and ship in validated dry shippers to keep cells under the glass transition and limit thermal cycling.

Thaw rapidly, then dilute or wash using your validated procedure. PluriFreeze Base can also be used to wash and concentrate cells after thaw, so one defined formulation carries them from collection through to the point of use.

Evidence that holds up in qualification

Evaluate the published post-thaw performance and viscosity data for PluriFreeze.

See the data

PluriFreeze performs on par with the industry standard in tested cell types, with lower viscosity for easier handling at scale.

 

• Comparable performance. Post-thaw viability, recovery, and expansion match the industry standard across pluripotent stem cell and NK cell lines.

 

• Lower viscosity. Developed for large-scale manufacturing, PluriFreeze PF10 is about 3.5 times less viscous at 5°C, so it moves predictably through tubing and closed systems.

Bar chart of dynamic viscosity at 5°C for 10% DMSO cryopreservation media: PluriFreeze PF10 2.11 mPa·s, Competitor A 2.15, Competitor B 4.05, Competitor C 4.11, Competitor D 4.85, and industry reference 7.29. PluriFreeze PF10 is about 3.5 times less viscous than the industry reference.

Savings that add up across every collection

Compare your cost per unit

When you freeze hundreds or thousands of units a year, the cost of freezing medium grows with every unit. Compare PluriFreeze PF10 with the ready-to-use product you buy today, based on your own annual volume.

PluriFreeze PF10 savings calculator: choose RUO or GMP grade, enter units frozen per year, freezing medium per unit, and what you pay today to see your annual savings

Fits the process you’ve already validated

Keep what already works in your process and add support for cells before and after the freeze.

What stays the same
Your freeze curves. Matched melting point and glass transition temperature mean your controlled-rate programs carry over.
Your storage and thaw procedures. Vapor-phase liquid nitrogen storage and your thaw, dilution, or wash procedures stay as they are.
Your DMSO concentration. Use PluriFreeze PF10 at 10% DMSO, dilute it with PluriFreeze Base to reach a lower final concentration, or request a custom concentration to match your protocol.
Your release assays. Assess PluriFreeze with the acceptance criteria and assays you already run, from viable CD34+ and TNC recovery to CFU.
What you gain
Protection from collection. The PluriFreeze Base wash and hold steps support cells through transport and processing.
Fully defined inputs. Both PluriFreeze Base and PluriFreeze PF10 are synthetic and animal-origin-free.
Formats that fit your process. Get bottles for your development work and bags with sterile connectors to support closed processing of apheresis products, including in controlled, non-classified (CNC) spaces as well as cleanrooms.
Put it to the test in your process

The strongest evidence comes from your own laboratory. Our experts can help you design a paired study with your product, measured against the acceptance criteria you already use.

researcher in lab with cryovial

Frequently asked questions

Find answers to our most commonly asked questions. If you don't see the information you are looking for, get in touch with our team. We're here to help.

Yes. Teknova manufactures PluriFreeze within its ISO 13485 QMS and the Type II Drug Master File held by Pluristyx supports developers incorporating PluriFreeze into clinical development and manufacturing programs. As with any ancillary material, qualify it for your process, and request a Letter of Authorization from Pluristyx at info@pluristyx.com to cross-reference the DMF in your IND or BLA.

Published data so far covers pluripotent stem cell and NK cell lines, where post-thaw results are on par with the industry standard. Because performance is application specific, our experts can help you design a study to generate that evidence with your own product.

Yes. The melting point and glass transition temperature of PluriFreeze Base and PluriFreeze PF10 align with the industry standard by differential scanning calorimetry (DSC), so your controlled-rate programs and vapor-phase storage carry over.

No. PluriFreeze Base and PluriFreeze PF10 are fully synthetic, chemically defined, and animal-origin-free.

Yes. Dilute PluriFreeze PF10 with PluriFreeze Base to reach a lower final DMSO concentration, such as 7.5% or 5%. Custom formulations with up to 30% DMSO are available on request.

Yes. PluriFreeze Base is a hyperosmotic holding solution that supports cellular products at 2–8°C for up to 72 hours between collection, transport, and processing, and it can also be used to transport viable tissue and organoids. Optimal hold time should be validated for each product type.

PluriFreeze Base and PluriFreeze PF10 are available as ready-to-ship 100 mL bottles in RUO and GMP grades, with custom fill volumes and formats on request. 

 

Store PluriFreeze at 2–8°C, protected from light. Its stability data show it keeps its performance for 2 years at both 2–8°C and room temperature, which is why it ships at ambient temperature without cold packs.

Each lot ships with a Certificate of Analysis, and Safety Data Sheets are available. Teknova manufactures PluriFreeze in RUO and GMP grades within its ISO 13485 certified quality management system, and every component is listed in the US FDA’s Inactive Ingredient Database. Pluristyx can provide a Letter of Authorization to cross-reference the Type II Drug Master File. Email info@pluristyx.com to request one.