Closed, automated devices with standardized processes. For the manufacturing and use of target cells in humans the national legislation and regulations e. Miltenyi biotec gmbh innovative medicines initiative. It delivers consistent product quality in every batch enabling reproducible cell production. The clinimacs prodigy represents the next generation in automated cell processing.
As a global market leader with numerous subsidiaries and distributors, miltenyi biotec is committed to providing our customers. The miltenyi machine, called the clinimacs prodigy, was small enough. The clinimacs prodigy is an automated device that can be used for cell. The clinimacs plus instrument automates cell separation for clinicalscale. The userfriendly key components of the clinimacs plus instrument offer sophisticated applications for a whole variety of separations. In 2016, miltenyi biotec released a tabletop device called the clinimacs prodigy that takes in a patients cells and automatically moves them. The stem cell product that was administered on b 6 2012, was processed per b 4 to select for cd34 cells while removing the cd3 tcells. A new device could speed up the process of genetically modifying blood. Use of miltenyi biotec s clinimacs cd34 reagent system as a humanitarian use device for isolation of hematopoietic stem cells or tcell depletion in multiple settings. Nucleophosmin 1 npm1 is a driver gene that is mutated in.
The system is based on magneticallyactivated cell sorting macs. This device offers advanced integrated solutions to streamline cell. Consequently, in 1997, the clinimacs cd34 system received the ce mark, registered as a medical device in europe, and was officially introduced into the. Miltenyi biotec is a global provider of products and services that advance biomedical research and cellular therapy. Using a singleuse tubing set, including a separation column, the device automatically applied the cell sample to the separation column. Miltenyi biotec with clinimacs cd14 beads miltenyi biotec, and. Stem cell transplant with clinimacs device childrens.
Gene therapy in a box effective, reports nature communications. Driving innovation shared facilities gmp manufacturing team science. The clinimacs prodigy is a closed and automated platform with the capability to manufacture various cell types on a single device and within a single process. Website, miltenyi biotec is a global biotechnology company headquartered near cologne in bergisch. All content is posted anonymously by employees working at miltenyi biotec. Medical device clinimacs cd34 largescale complete kit. Watch the video to see what motivates our scientists, engineers, it professionals, and marketeers. Clinimacs devices provide stable cell separation technology and the most advanced member of this product line, the clinimacs prodigy, enables automated.
Mutated nucleophosmin 1 as immunotherapy target in acute myeloid. 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. Cart cell production using the clinimacs prodigy system. Using clinimacs systems, cell products have been manufactured for all stages of clinical. Miltenyi biotec is a global provider of products and services that advance biomedical research and cell and gene therapy. The clinimacs plus instrument automates cell separation for clinicalscale enrichment of target cells or depletion of unwanted cells in a closed and sterile system. Food and drug administration fda has approved the companys clinimacs cd34 reagent system as a humanit. The companys reagents and devices are used primarily in the research.
Optimized process specific programs for the clinimacs prodigy device by performing experimentation and debugging. Methods in collaboration with miltenyi biotec, we obtained. The clinimacs reagents in combination with the clinimacs system are intended to separate human cells. Using a singleuse tubing set, including a separation column, the device. As a global market leader with numerous subsidiaries and distributors, miltenyi biotec is committed to providing our customers around the world with the highest quality products. Clinimacs tubing set ts is a singleuse, sterile, disposable tubing set with two proprietary cell separation columns used as part of the clinimacs cd34 reagent system. Medical devices medical device clinimacs tubing set ref. Application development at miltenyi biotec sv san francisco bay area 500. Clinimacs system macs cell culture macs media macs cytokines therasorb. We need robots to make the cancer meds of the future ieee. Medical device clinimacs cd34 largescale complete kit 16901.
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