The Celsius® S3 Benchtop System is the only laboratory instrument available on the market to evaluate freeze & thaw processes of new drug candidates in single-use bags with full scalability to production-scale Celsius® platforms (FFT, FFTp and CFT). This tool allows generation of consistent samples library useful for evaluating stability, storage and shipping conditions and formulations.
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The Celsius® S3 Benchtop System is the only lab-scale freeze & thaw system in single-use bags that is scalable to our production-scale Celsius® platforms (FFT, FFTp and CFT). This system is a tool to execute freeze & thaw process development and stability studies using a minimal amount of product.
The Celsius® S3 Benchtop System models production system with a minimal amount of product. Using the same freeze & thaw critical process parameters and identical materials of construction in all Celsius® Pak, the Celsius® S3 Benchtop System ensures unmatched scalability between all scale systems.
Ease of Use
The CryoPilot Control Unit provides automated operation and data collection. The Celsius® S3 Benchtop System freezes and thaws from 1 to 10 product samples per run. Lab-scale Celsius® Pak PDS are available in sizes of 30 mL and 100 mL nominal fill volume with different filling port and thermowell configurations.
Improved Process Validation
Celsius® S3 Benchtop System offers excellent batch to batch reproducibility and consistent product stability after freezing, thawing and storing. The Celsius® S3 Benchtop System provides documented and reproducible freeze & thaw processes, thus facilitating validation of your freeze and thaw operations.
Celsius® S3 Benchtop System Applications:
- Process development studies to understand decoupling (hold) steps during downstream processing, i.e., frozen storage of process intermediates, frozen storage of drug substances. Investigate the Celsius® technology for future scale-up. (FFT, FFTp and CFT)
- Scale-down storage and transportation studies (using minimal volumes as low as 20 mL) for understanding extended drug substance storage (time and temperature) and shipping
- Formulation development of freeze & thaw compatible formulations for drug substance
- Stability Studies in accordance to industry guidelines, conducted in freezing and thawing conditions as well as in a container closure system that is the same as or simulates the packaging proposed for freezing, storage, shipping and thawing at production-scale
Celsius® Lab-scale implements small-scale single-use Celsius® solutions to support production-scale freezing and thawing operations with the Celsius® technology. Scalability is a feature unique to Celsius®. Lab-scale Celsius® Paks together with the process development tool called Celsius® S3 Benchtop System allow you to characterize the freeze & thaw processes on your biopharmaceutical product in the lab before scaling-up to the production system.