Smarter Decisions Made to Scale with the Celsius® Lab-Scale Solution
A True End-to-End Integrated Freeze/Thaw System
Sartorius offers lab-scale Celsius® solutions for smarter and earlier process decisions in managing frozen drug substances. The Celsius® lab-scale platform enables freeze/thaw characterization in 30–100 mL single-use bags with full scalability to commercial-scale Celsius® platforms (CFT, FFT and FFTp).
An end-to-end integrated approach for faster and more efficient testing and validation, assuring product quality at scale
Minimal amount of product needed for economical and simple process development activities
Same product contact material of freezing containers between lab and commercial-scale solutions
Investigatory tools to establish optimal process conditions and ease freeze/thaw deployment at commercial scale
Create models to precisely simulate temperature profiles of different freeze/thaw technologies.
Reproduce freeze/thaw conditions using the same product contact material for scalability to all Celsius® commercial-scale solutions (Celsius® CFT, FFT and FFTp)
With a large variety of solutions, the Celsius® platform ensures a fast, economical and easy-to-adopt frozen transfer for process development.
Full Process Scalability From Lab to Commercial Scale
Celsius® S3 Benchtop Freezing Platform
The Celsius® S3 Lab System combines freeze/thaw expertise and single-use technology to enable a seamless move from laboratory tests via process development to cGMP clinical and commercial production.
- Reproduce identical freeze/thaw conditions obtained at commercial scale
- Generate a consistent samples library to investigate product stability, storage and shipping process steps
- Use a minimum working volume of product, managing costs and reducing waste
The Lab-Scale Solution that Offers a Glimpse of the Future
Provide flexibility and predictability to expand future production with a lab-scale technology that replicates Celsius® commercial-scale solutions (Celsius® CFT, FFT and FFTp) by design.
Attribute | Celsius® CFT | Celsius® FFT | Celsius® FFTp |
|---|---|---|---|
Platform | Container plus benchtop freezer | Container plus benchtop freezer | Container plus benchtop freezer |
Scalability | From 1 to 100L scale vertical plate freezer | Conventional/blast freezer performance | Horizontal plate freezer performance |
Studies | Scale-up, scale-down, stability studies | Scale-up, scale-down, stability studies | Scale-up, scale-down, stability studies |
Container material | Identical | Identical (option w/o thermowell) | Identical (option w/o thermowell) |
Container range | 30mL - 100mL | 30mL - 100mL | 30mL - 100mL |
Sartorius offers frozen storage and shipping solutions to meet the challenges of the biopharmaceutical cold chain, and the confidence that comes with having an experienced partner. With global operations and an extensive network of engineers and industry experts, Sartorius provides the technology, expertise and support that manufacturers need to succeed.
