The CliniMACS Prodigy - amc

1 The CliniMACS Prodigy jason jones Manager, Cell Therapy and Therapeutic Apheresis Miltenyi Biotec Ltd. What is the CliniMACS Prodigy ? How does it do it? What does it do availabilities? Agenda >40,000 clinical procedures performed. More than 700 instruments in the field. CE marked since December 1997. Now FDA approved for CD34 selections in AML. Cellular Therapy on the CliniMACS System MACS Cell Therapy HSCT Graft and DLI Engineering Adoptive immunotherapy: T Cells, DC s, NK s, etc. Regenerative medicine Heart and Vasculature, Liver, Bone, Nervous system, etc. Cellular Therapies using the CliniMACS System MACS Cell Therapy CliniMACS Plus Protocol Processing time about Hands on.

2 Open steps. Reformulation of end product. CliniMACS Plus Process Safety Product limit manual steps, connections and reconnections. Operator minimise potential exposure to agents. Costs Reduced hands-on time Reduced clean room requirements Freeing up higher grade rooms/areas Manufacturing of cells in OR Reproducibility/ease of use Fully-automated and controlled process Requirement for a Closed System CliniMACS Plus CliniMACS Prodigy Next Generation Cell Processing Platform CliniMACS Prodigy Instrument .. Integrated Cell Processing from cell source to final cell product: Sample preparation: Cell washing, density gradient separation Magnetic cell labelling MACS cell separation Cell culture (activation, differentiation, maturation) Final product formulation Automated manufacturing Closed system + + + = + +.

3 Designed to replace or integrate What is the CliniMACS Prodigy ? How does it do it? What does it do availabilities? Agenda Magnet Unit Liquid Sensor Pinch valves Peristaltic pump Bag hangers CentriCult Unit Bag Compartment Touch screen Gas Mix Unit CliniMACS Prodigy main components Tube Sealer Bar code reader CentriCult chamber - washing and culture Boundary-layer-detection Cell Culture Microscope Temperature control: 4-38 C Atmosphere control (CO2, N2, Air) CentriCult Unit CentriCult chamber Connections Filter Double prism Total volume: 400ml Max. sample volume: 300ml Centrifugation: up to 2500rpm (400g acceleration) Optimised cell pellet volumes (40ml/80ml) Port at the lid Port at the bottom Cross section: Sample load & fractionation 0 min Plasma Leucocytes Erythrocytes 15 min & layer detection load Straps Sophisticated packaging design with mounting aids Closed, sterile, single-use tubing sets Tubing Set installation Dedicated vs.

4 Flexible CliniMACS Prodigy TS TS 310: dedicated tubing set TS 710: flexible tubing set Customisation of Tubing Sets with Accessories Double Vial Adapter Single Vial Adapter 1 m Tube Extension 3-way Tube Adapter Single Sampling Adapter Triple Sampling Adapter Sterile Filter Adapter In-Line Filter Adapter (260 ) Continuous process: 50 L 200 mL Concentration of cell culture suspension (1-50 L) 1-50 L 200mL 120ml/min Recovery 80-90% Viability >90% Fully Integrated Yet Also Modular What is the CliniMACS Prodigy ? How does it do it? What does it do availabilities? Agenda Roll-out plan CE-applications 2014 Q4/2013 Q1/2014 Q2/2014 Q3/2014 Q4/2014 Q1/2015 BM-133 Enrichment CCS-IFN Enrichment (CE-mark TS 500 Nov 4th 2013) LP-TCRab-19 Depletion LP-3- 19 Depletion LP-34 Enrichment CE-Mark TS 310 Medical CE Research Use Development LP-14 Enrichment for MoDCs LP-304 Enrichment for PDCs CE-Mark TS 510 Viral Transfection process.

5 CAR-T cells Roll-out of additional applications in 2014 Q4/2013 Q1/2014 Q2/2014 Q3/2014 Q4/2014 Q1/2015 Research Use Development Enrichment 2 (TS 100/TS 310, 6/12E8, 40/80 mL cell pellet, staged loading) Ficoll (TS 710) Cell Concentration (TS 720, up to 50 L, 120 mL/min) Flexible cultivation applications (TS 730) RBC Reduction (TS 710) Enrichment 1 (TS 100, 6E8, 40 mL total cell pellet) Electroporation module for RNA & DNA transfection Closed System: cell processing + electroporation Multi-use cuvettes: large volumes easy handling time saving Specs: - up to 1000 V - up to 250 ml Volume - up to 250 shots Cell Processing Module for Further Applications And On Into The Closed-system pre-sorting and flourochrome labelling Closed-system flow cytometric sorting.

6 Closed-System Processing. Standardisation. Reproducibility. GMP Compliance. Automation. Cost Saving. Flexibility. The CliniMACS Prodigy Mastering the complexity of cell processing Watch our new Prodigy Video on Miltenyi TV Thank You