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TRANSCRIPT
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 4.5h. Hands on. 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
+ + + =
+ +
… 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: 4-38ºC
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
2. Fractionation & layer detection 1. Sample load
Straps
Sophisticated packaging design with mounting aids
Closed, sterile, single-use tubing sets
Tubing Set installation
Dedicated vs. 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 µ)
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: 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 Future……
Closed-system pre-sorting and
flourochrome labelling
Closed-system flow cytometric sorting.
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