Celsius® CFT – The Controlled-Rate Freeze & Thaw Platform Technology

Fast, Safe and Reproducible Freeze and Thaw Processing

The Celsius® CFT is an industry-leading technology that controls the freezing and thawing rate to minimize cryo-concentration in biopharmaceutical products. This robust and reliable platform ensures bulk drug substances are well-protected from start to finish, and offers process flexibility by processing up to 100 L of solution in single-use Celsius®-Paks. Qualified shipping solutions are offered as part of the Celsius® CFT platform.

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Maximum Product Safety

Celsius® CFT is focused on product security throughout the container’s life cycle from fill through drain and will stabilize drug substances with controlled-rate freeze thaw processes.

Celsius®-Pak are pre-sterilized disposables, Closed Container Systems, secured in structural frames for robust handling at low temperatures as proven through extensive functional qualification with over 100 tests performed in real and extreme process conditions. The entire process logistics is controlled from filling to dispensing, including frozen transport, to easily and safely manage larger frozen bulk volumes. Our innovative Celsius® CFT single-use platform, combining hardware and single-use systems provides fast (5 hours to freeze 100L of product down to -60°c, every time) and uniform thermal cycling to preserve product stability and mitigates the major adverse effects of large scale freezing and thawing of biologics.

“Slow freezing rates can result in cryoconcentration.This can further lead to pH shifts and phase separation among those components resulting in protein structural damage” (Puri & Al., BioProcess International 13(1), January 2015)

“Controlled-rate technologies such as Celsius® CFT prove to be much more efficient than the conventional uncontrolled-rate methods ...and also show minimal to negligible cryoconcentration” (PDA J Pharm Sci and Tech 2010, 64 290-298).

Process Flexibility

Process Flexibility creates opportunity to improve and expand manufacturing networks

Celsius® CFT allows you to confidently decouple process steps to maximize productivity and flexibility of your manufacturing site. This capability increases capacities by extending the product shelf-life, by stockpiling and enabling batch processing and will support easy transfer between Drug Substance & Drug Product sites (one-way logistics possible) with pre-qualified shippers (mechanical: ASTM D4169 AL1; thermal: ISTA7D extreme summer), facilitating as well management of multi-product facilities.

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Reliable and Reproducible Operations

Complete platform from one supplier ensures excellent integration and full accountability. Well controlled operations and monitoring as well as reporting of the CQAs (Critical Quality Attributes) ensure high reliability and batch-to-batch reproducibility in cGMP processes.

The entire automatic freeze, thaw and hold operations are controlled from the Control Cabinet of the modular Celsius® 100 equipment . Connected to the Temperature Control Unit and the Celsius® FT module, the critical parameters of the different process steps are commanded, monitored and stored in an automatic manner with minimal operator intervention.

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Scalability with 30ml Celsius®-Paks

Celsius® S3 laboratory-scale system conveniently fits on a common benchtop and is the ideal tool to explore the impact of production-scale freeze & thaw operations on your product.

Celsius® CFT is the only fully scalable single-use technology for freeze & thaw on the market. With the Celsius® S3 system R&D and Process Development scientists can quickly explore and properly design future production-scale freezing and thawing processes for their products. Celsius® S3 reproduces the freeze & thaw rates observed in the large-scale FT100 sytem while maintaining the freezing path length of the Celsius®-Pak providing a unique tool to run stability and compatibility studies and aide in formulation development.

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Single-use Containers for controlled Freeze-Thaw Processes

Celsius® Pak are sterile, single-use, disposable containers specifically designed to be used in the Celsius® CFT controlled freeze-thaw systems offered by Sartorius Stedim Biotech. The combination of a reusable structural frame with a sterile container provides unique advantages in robustness, handling and transportation. Celsius®-Pak are available in a range of volumes from 30mL to 16.6L.

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Step 6: Bulk Drug Substance Filtration

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Rapid and cost-effective single-use / hybrid solutions from early phase development through scale-up to commercial manufacturing.

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