Protocol optimization
Testing formulation and process parameters, such as cryoprotectant concentration, cell density, cooling, and thawing, against your cells’ post-thaw recovery and function.
Cell therapies are living drugs, and many have to be frozen to reach patients
Freezing lets a therapy be made in one place and given to a patient in another, weeks or months later. It’s also one of the harshest things the cells go through.
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Adding cryoprotectant
Before freezing, cells are mixed with a cryoprotectant such as DMSO. It protects them from ice, but it becomes toxic with time and temperature, and adding it makes cells shrink and swell as water moves out and back in.
- Cryoprotectant toxicity
- Osmotic stress
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Cooling
Samples cool below 0 °C before ice forms, and unless it’s controlled, the point where it forms varies from sample to sample. Cool too fast and ice forms inside cells, which is usually lethal. Cool too slowly and cells spend longer in increasingly concentrated salts as ice grows around them.
- Ice nucleation
- Intracellular ice
- Solution effects
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Storage and delivery
Below about −150 °C, cells are effectively paused. But transfers, freezer-door openings, and shipping delays can warm them briefly, and repeated excursions give ice a chance to change and cause damage.
- Temperature excursions
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Thawing and dilution
Warming needs to be fast, because slow warming gives small ice crystals time to grow into larger, damaging ones. Diluting or washing out the cryoprotectant then puts cells through another osmotic swing.
- Ice recrystallization
- Dilution stress
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After thaw
Cells that look healthy right after thawing can die or lose function over the following hours. Time at room temperature before infusion adds more cryoprotectant exposure.
- Delayed cell death
- Loss of function
Each of these can be managed, but the right settings depend on the cells, the formulation, and the process.
Confidence in your cryopreservation, backed by data
We’re building a platform to help cell therapy developers optimize the critical process parameters behind cryopreservation and generate the data to show how well their protocol holds up.
We’re looking for early partners to help shape it.
Robustness testing
Mapping how much room your protocol has for real-world variation: hold times, temperature excursions, thaw conditions, and differences between batches.
Data you can build on
Results reported in a form that supports process development, tech transfer, and CMC documentation.
Earlier is cheaper. Once clinical material has been made, changing a cryopreservation protocol usually means showing the product is still comparable. Getting it right early reduces that risk.
Cryopreservation deserves the same rigour as the rest of the process
In many cell therapy programs it’s set early, with general-purpose media and default protocols, then left alone.
Vitrisium is an early-stage startup working to change that.
Get in touch
We’re looking for early partners: cell therapy developers heading toward the clinic, teams seeing losses or variability after thaw, and manufacturing partners. Tell us what you’re working on.