EXPERTISE
Simulation of Freeze-Thaw Processes
Smartfreez is 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. Also, it uses its CFD models to aid in designing its methods and equipment for its customers.Addicionally, Smartfreez currently provides digital-twins, to anticipate cryopreservation hurdles with minimal experimental testing, to reduce costs and to shorten the development period of freeze-sensitive molecules.
Instruments for Accelerated Cold-Stability Assessment
We 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. This allows for discerning the effect of temperature, by cold denaturation, from the interfacial stresses related to ice. Moreover, the system can anticipate long-term storage stability in a short time frame. This is relevant for optimizing formulation or cold chain logistics.
Instruments and Methods for Down-Scale Studies
The Micro Scale-Down instrument developed by Smartfreez, can recreate the freeze-thaw stress of bottles or bags in a much smaller volume (below 10 mL). CFD simulation can be used to generate the distribution of stresses during freezing and thawing. Specifically, CFD can account the time that a sensitive molecule stays within the ice structure and above glass transition. This 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. Based on CFD simulation, the Micro Scale-Down can convert a vial with less than 10 mL into a representative physical model for freeze-thaw stress in 2L to 20 L manufacturing containers.
Integrative Freeze-Thaw Systems
We design single-use systems that achieve high stability and consistency during freezing and thawing of both bottles and bags. These systems can be easily made compatible with existing manufacturing platforms, such as existing freezers.
Furthermore, our Digital-Twins provide an accurate assessment of system performance, enabling customers to maximize scalability, anticipate hurdles, and accelerate time-to-market.
