Sefia Select™ system
Automate and close your cell isolation, cell harvest and formulation for cell therapy manufacturing with the same versatile system
Sefia Select™ system
Automate and close your cell isolation, cell harvest and formulation for cell therapy manufacturing with the same versatile system
Type
Overview
Sefia Select™ system comprises two hardware components, specialized application software, and single-use kits to provide a closed and automated solution to your cell therapy manufacturing needs; resulting in an efficient, secured and standardized process.
- Streamlined manufacturing. Increase automation level of three key steps of your cell therapy manufacturing.
- Flexibility to meet your process needs. Adapts to your specific process and the variation in initial product by utilizing different application parameters.
- Features designed to reduce batch failure risk. Closed processing keeps contaminants out. Sensor monitoring and automation facilitate control of the process.
- Designed to increase productivity. Reduced operator touchpoints and labor hours optimize your resources and potential for human error.
- Easy integration. Friendly user design of applications and consumables. Centralized traceability, consistent setup duplication and regulatory compliance thanks to Chronicle™ software connectivity.
To support different steps in the cellular therapy manufacturing workflow, dedicated application software and single-use kits have been developed on the Sefia Select™ system. Each application software provides user-definable parameters to give the flexibility to configure process steps, support the automation and guide the user during the procedure.
| Application software | Workflow step | Description | Single-use kit |
|---|---|---|---|
| PremierCell | Isolation | Mononuclear cells enrichment via density gradient medium from fresh or thawed apheresis | CT-300.1 |
| MagnetSelect | Isolation | T cells isolation via magnetic nano beads from fresh or thawed apheresis | CT-400.1 + PB-100.1 |
| S-Wash | Harvest | Concentration and washing of expanded cells up to 1.2 L or thawed cellular product | CT-200.1 |
| FlexCell | Harvest and Formulation | Concentration and washing of cells up to 10 L and formulate up to 3 final bags | CT-800.1 |
| ReadySelect | Formulation | Preparation of a cellular product ready to be used and/or cryopreparation of up to 4 final doses | CT-350.1 |
The Sefia Select™ system can be connected to Chronicle™ software, a unified digital platform to monitor cell therapy manufacturing operations and supply chain logistics. Chronicle software enables the digitization of manufacturing documentation by generating electronic Batch Manufacturing Records (eBMRs) through the use of Electronic Standard Operating Procedures (eSOPs). It also offers the ability to monitor instrument data in real-time and receive alert notifications via SMS and emails. Chronicle™ software centralizes the creation, approval, and deployment of parameter groups on connected Sefia Select™ systems. Chronicle™ software supports cell therapy process development and manufacturing in compliance with FDA 21 CFR Part 11 and EU Annex 11.
