Description
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.
Applications
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
Disclaimer
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 as a Humanitarian Use Device (HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this indication has not been demonstrated. Other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or FDA approval.
CR/GMP products are for ex vivo cell processing only, and are not intended for human in vivo applications. CR/GMP products are designed, manufactured and tested under an ISO 13485 quality management system and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The manufacturing and testing of CR/GMP products of biological origin are in compliance with EP chapter 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”.
Overview
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.
