Innovative solutions dedicated to Cell & Gene Therapy automation. Jules Bourgon AMC Technical Meeting,
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1 Innovative solutions dedicated to Cell & Gene Therapy automation Jules Bourgon AMC Technical Meeting,
2 Biosafe Group SA founded in Geneva, Switzerland in 1997 internationally active medical technology company A technology offering automated and closed cell processing solutions 20 years of experience in stem cell processing 2016: Biosafe Group SA, part of GE Healthcare company :
3 T Biosafe unique technology How centrifugation can be closed and automated? Closed environment: Single-use kit & Input/Output in bags Automated system: T T Fluids management & Centrifugation Flexible system: Adjustable volume & Applications-specific protocol 2
4 Biosafe expertise in Cord Blood Banking 20 years experience with public and private banks volume reduction of cord blood banking Repeatable, closed and fully automated Biosafe expertise in Point of Care Portfolio of 9 protocols for transplant centres, including BM and PBSC volume reduction RBC depletion for ABO incompatibility Washing to remove cryoprotectant
5 Cell and Gene therapy automation Purification / concentration Why automate? Thawing / preparation To control and standardize cell therapy process Cell Therapy manufacturing workflow To assure the integrity and sterility with a closed and single-use system Final formulation / Dosing Concentration & Washing To scale up while keeping flexibility To have a full traceability How Biosafe and GE expertise address these needs? 4
6 Biosafe expertise to automate cell therapy manufacturing CellThaw CultureWash Thawing / preparation Purification / concentration SmartRedux PeriCell CultureWash NeatCell CellCryo Final formulation / Dosing Dilution Concentration & Washing CultureWash
7 Identified needs from market for process automation To process large volumes (from 1 to 10L) To automate complex processes To manage the variability of starting material To keep high level of flexibility on parameters To fit with regulatory requirements 6
8 Sefia platform: a new solution for process automation 7
9 Flexible platform + + Sefia main processing unit Protocol(s) processing software Single-use kit closed and sterile 8
10 Sefia platform: a new solution for process automation Fast processing of large volume through continuous-flow technology NEW DESIGN WITH 2 PATHWAYS Peristaltic pump 9
11 A new patent pending technology: Sequential and continuous-flow centrifugation 10
12 Sefia platform: a new solution for process automation Fast processing of large volume through continuous-flow technology Flexible system with up to eight fluid pathways 11
13 Sefia platform: a new solution for process automation Fast processing of large volume through continuous-flow technology Flexible system with up to eight fluid pathways Smart and secure process via multiple sensors Weight sensors Pressure monitoring sensors Optical and air bubble detector Air level detector 12
14 Sefia platform: a new solution for process automation Fast processing of large volume through continuous-flow technology Flexible system with up to eight fluid pathways Smart and secure process via multiple sensors Intuitive user guidance and full traceability user-friendly design barcode reader 13 touchscreen
15 Sefia platform: a new solution for process automation Fast processing of large volume through continuous-flow technology Flexible system with up to eight fluid pathways Smart and secure process via multiple sensors Intuitive user guidance and full traceability Temperature regulation (coming soon) Thermal rocking shaker module for in-bag fluid mixing Peltier module for chamber temperature control 14
16 Sefia platform: a new solution for process automation Fast processing of large volume through continuous-flow technology Flexible system with up to eight fluid pathways Smart and secure process via multiple sensors Intuitive user guidance and full traceability Temperature regulation (coming soon) 15
17 1st protocol: FlexCell, advanced cell washing Multiple applications Volume reduction Washing Final formulation Flexible parameters Opened to adapt needs Controlled access 16
18 CT kit: Single-use kit Color-coded tubes CLOSED AND STERILE EASY TO USE FAST & FLEXIBLE 17
19 Biosafe proposal to automate cell therapy manufacturing Purification / concentration Thawing / preparation Final formulation / Dosing Concentration & Washing FlexCell
20 Thank you for your attention and come see the Sefia at our booth! Questions? Biosafe Group SA CH Eysins-s/Nyon Switzerland T F info@biosafe.ch 19
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