Description
Sefia™ expansion kit is available in two types (FEP: fluorinated ethylene propylene and Si: silicone) to meet different customer needs. Sefia™ expansion system Universal application offers high flexibility with customizable parameters to enable the user to fit the procedure to their specific needs. Universal application covers three consecutive steps of your cell therapy manufacturing: cell activation, transduction and expansion. You can start a procedure with Universal application with cellular product using a mass of between 5 and 250 g. Universal application default parameters are designed to execute one of many possible types of workflow, typically taking between 5 to 12 days. The cells are cultured in static culture vessels with temperature and CO _2 concentration control and monitoring. Sefia™ expansion system can be used with your current reagents and media. It has been tested with market leading activators and media as well as various types of viral vectors (lentivirus and retrovirus). Different methods can be used to support the cell expansion: batch, fed-batch or perfusion. At the end of the procedure, the genetically modified and expanded cells will be harvested in a bag up to 1200 g. The Sefia™ expansion system can be connected to Chronicle™ automation software to monitor cell therapy manufacturing operation 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™ expansion systems. Chronicle™ software supports cell therapy process development and manufacturing in compliance with FDA 21 CFR Part 11 and EU Annex 11.
