Description
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.
