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® 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. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use.
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 CliniMACS Prodigy. For individual procedures, it will require a single-use chamber, which is included as part of specific CliniMACS Prodigy Tubing Sets. A Layer Detection Camera automatically determines the optimal cell fractionation endpoint by discerning the macroscopic layers of the source cell product.
The magnetic cell separation unit comprises a second integral component of the CliniMACS Prodigy enabling the magnetic separation of virtually any cell type.
The CliniMACS Prodigy has been developed as an integrated cell processing device in order to automate and standardize the complete manufacturing process of cellular products:
- Fractionation of starting material
- Cell washing
- Target cell labeling
- Magnetic cell separation
- Cell cultivation
- Volume reduction
- Final product formulation
CliniMACS Prodigy® with attached tubing set and various bags
CliniMACS Prodigy® with attached tubing set and various bags
CliniMACS Prodigy® – Mastering the complexity of cell processing
The CliniMACS Prodigy® offers a unique all-in-one solution for cell processing in a closed GMP-compliant system. This next-generation instrument is pivotal in propelling cell processing to the next level of automation.
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