COLD STABILITY ACCELERATOR – A NEW AUTOMATED SYSTEM TO PREDICT COLD STORAGE STABILITY
You can replicate in a few days, years of the freezing behavior for each protein, saving time, anticipating its lifespan, measuring its stability and optimizing its cryopreservation method.
The Cold Stability Accelerator is based on capability of running isothermal stability studies below freezing temperature while preventing ice growth, using the isochoric method.
This system is ideal for measuring degradation kinetics of small volume biomaterials in aqueous solutions below the normal freezing temperature, assuring high reproducibility and consistency of the temperature-time profile of each sample.
The CSA clarifies the behavior of proteins over a wide temperature range (-25 to 0 °C), allowing for consistent models and avoiding the uncertainty associated with extrapolations used in the generalized method for accelerated studies (using high temperatures).
ADVANTAGES OF THE COLD STABILITY ACCELERATOR
The Cold Stability Accelerator is an automated system with a user-friendly interface that offers user access control, customised protocols according to the sample used and access to data logging.
The Cold Stability Accelerator uses a simple method comprising only 5 steps: (1) filling the high-pressure container with the biomaterial solution , (2) closing the container with a nucleating-lock, (3) allowing the container to reach the assay temperature, (4) removing the container at selected time and (5) opening the container to recover the biomaterial solution.
The Cold Stability Accelerator enables to perform accelerated stability studies for several product formulations at below freezing temperatures.
The Cold Stability Accelerator allows to rapidly evaluate the sensitivity of the molecule to the impact of stabilizing conditions (buffer, pH) or excipients (sucrose, trehalose, polysorbate,…) at freezing temperatures, and therefore to optimize the product formulation process, highlighting future stability risks caused by freezing, for further correction.
SHELF LIFE EXTENSION
The Cold Stability Accelerator contributes to clarify the mechanisms of protein aggregation and predict frozen storage stability.
The Cold Stability Accelerator will provide data and guidelines for producing more stable product formulations and consequently the aggregation risk can be minimized and the shelf life can be extended further with all the associated manufacturing and logistic benefits.
SMARTFREEZ’S COLD STABILITY ACCELERATION SERVICE
In case you wish to better understand the outcome and results of this method on your biologic products, SmartFreeZ offers Cold Stability Acceleration as a service.
THE COLD STABILITY ACCELERATOR EQUIPMENT
- High reproducibility
- Easy to operate through display interface
- Programmable protocols and data registration
- High accuracy control of temperature
- High consistency of the temperature-time profile
- Designed for easy cleaning
- Overall size: width 31cm, depth 46cm, height 60cm
- Weight: 40Kg
- Capacity: 12 containers, each with three wells of 400 µl
- Programmable temperature range: - 30 °C to 30 °C