Software as a Service
Smartfreez has specialized in modelling phase-change of complex biological (aqueous) systems to simulate freezing and thawing related to the cryopreservation of biologics (such as proteins or cells). Smartfreez CFD models have been used to assist the design of Smartfreez methods and equipment, or its customers.
Digital-Twins are currently provided by Smartfreez, to anticipate cryopreservation hurdles with minimal experimental testing, to reduce costs and shorten development period of freeze-sensitive molecules.
Instruments for Accelerated Cold-Stability Assessment
Smartfreez design systems that provide experimental assessments of degradation rates at low temperatures.
The Cold Stability Accelerator measures isothermal degradation rates below freezing temperature without freezing the samples, enabling us to discern the effect of temperature (by cold denaturation) from the interfacial stresses related to ice.
This system can also anticipate long-term storage stability in a short time frame, which is relevant for optimizing formulation or cold chain logistics.
Instruments and Methods for Down-Scale Studies
It is also developed by Smartfreez the Micro Scale-Down instrument, which can recreate a bag´s freeze-thaw stress or bottle in a much smaller volume (as 5 mL). CFD simulation can generate the distribution of stresses during freezing and thawing. For example, the time that a sensitive molecule stays within the ice structure and above glass transition is directly related to its degradation rate during freeze-thaw.
This “stress-time” varies across the container; for example, the stress at the walls is different than at the center. Micro Scale-Down by Smartfreez can convert a 5 mL vial into a representative physical model for freeze-thaw stress in 2L to 20 L manufacturing containers.
Integrative Freeze-Thaw Systems
Smartfreez systems use single-use technology to achieve high stability and consistency during freezing and thawing, either in bottles or bags, which can be made compatible with existing manufacturing platforms (as existing freezers).
Smartfreez Digital-Twins provide an accurate assessment of performance, which can be used to maximize scalability, anticipate hurdles and accelerate time-to-market.