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The CliniMACS Prodigy represents the next generation in automated cell processing. This device offers advanced integrated solutions to streamline cell processing workflows – from cell separation through cell culture to formulation of the final product.
The CliniMACS Prodigy offers a flexible platform for cell processing applications enabling the magnetic separation of different cell types as well as customized cell processing protocols. The cell processing unit for fully automated washing, fractionation and cultivation of cells represents an integral component of the device. These processing steps take place in a single-use chamber, which is included as part of specific CliniMACS Prodigy Tubing Sets. The magnetic cell separation unit comprises a second integral component, enabling the separation of virtually any cell type.
|Dimensions||73.5 cm × 40 cm × 48 cm (w × d × h)|
|Weight||approx. 70 kg|
|Input voltage||100–240 V~|
|Power consumption||810 W|
|Pump speed||2–400 mL/min|
|Atmosphere control||Gas mix unit for CO2, compressed air, and N2; min. pressure: 1 bar, max. pressure: 2.5 bar|
|Temperature control||+4 °C to +38 °C|
|Centrifugation||Max. 2,500 rpm (400×g)|
|Microscope camera||Max. magnification: 400-fold|
|Monitor||10.1” TFT touchscreen|
|MACS tube sealer||For sealing CliniMACS Prodigy Tubing Sets PVC tubes|
|Types of starting material||Leukapheresis, bone marrow, cryopreserved PSCs|
|Available cell processing steps||Cell washing, density gradient centrifugation, cell activation, fluorescent antibody labeling of cells, cell depletion and / or enrichment via magnetic cell separation, viral transduction, cell expansion, expansion and differentiation of adherent cells, cell culture and medium exchange, formulation of final cell product|
|Tubing Sets and accessories||Dedicated CliniMACS Prodigy Tubing Sets and Accessories available|
|IPC/QC||Integrated IPC/QC sampling pouches allow sterile sample removal|
|Manufacture and availability||Manufactured in Germany and shipped worldwide|
Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use. MACS® GMP Products are for research use and ex vivo cell culture processing only, and are not intended for human in vivo applications. For regulatory status in the USA, please contact your local representative. MACS GMP Products are manufactured and tested under a quality system certified to ISO 13485 and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The CliniMACS® System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations – e.g. for the EU the Directive 2004/23/EC (“human tissues and cells”), or the Directive 2002/98/EC (“human blood and blood components”) – must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved; all other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE). CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.
In the US, the CliniMACS Prodigy® T Cell Transduction Process is available for research use only.
CliniMACS, CliniMACS Prodigy, MACS, and the MACS logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. Copyright © 2019 Miltenyi Biotec B.V. & Co. KG and/or its affiliates. All rights reserved.
A wide variety of cell processing applications are supported by the CliniMACS Prodigy platform. Learn more about the highlighted applications below or get an overview of the full potential of the platform and all available workflows by visiting our clinical application page.
Copyright © 2020 Miltenyi Biotec and/or its affiliates. All rights reserved.