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