The CliniMACS Prodigy instrument works as part of a system using disposable, single- use closed Tubing sets in conjunction with the instrument's fluidic controls so that the contents being processed will not be exposed, remain sterile, and will not actually interact directly with the instrument. www.miltenyibiotec.com/products/clinimacs-prodigy.html
Hi Nat, yes the transduction is also done by CliniMACs prodigy. the viral vector can be sterilely connected to the tubing set. The user can flexibly decide when the cells should be transduced during the culture phase. He can program the activity "transduction" in the so called activity matrix and key in the volume of the vector as well as the time when the transduction should be performed. When the defined time is reached, the prodigy will ask the operator to connect the viral vector. Subsequently the vector will be transferred to the cells in the prodigy chamber automatically. If you have further question, please contact us directly www.miltenyibiotec.com
Very cool, it seems that positive magnetic selection was done to isolate cells from apheresis product. Cells are then expanded but how do you purify the labeled cells from expanded cells? Do you require de-beading?
Dear Avanish, thank you for your question, no, our target cell preparations are not de-beaded. Indeed, as a consequence of the labeling it is possible that Target cell preparations obtained by the processing through the CliniMACS System may contain residual amounts of the reagent bound enriched cells along with the expanded and manipulated cells. However, the safety of the iron/dextran formulation used for the manufacturing of the CliniMACS Reagents (these are bound to the cells) has been evaluated by a careful literature review and a detailed risk assessment was done including data gained and presented to the regulatory bodies. In our CAR-T process the amount of still labeled cells is further lowered through the performed manipulation and cell cultivation steps, when comparing to the complete target cell preparation at the end of the process. Overall the potential risk presented by the minimal amount of beads which may be injected in the patient along with the CAR-T cells is very minimal. Furthermore, since CliniMACS System first introduction to market in 1997, no side effects have been reported in the context with the iron dextran formulation. I hope this answers your question, please let me know if any supportive arguments are still required and if open questions still remained.
Hi Madhu, the short answer is yes to both questions. The whole entire process from enriching the T-cells, Activate, transduce (engineer the T-Cells) and expand them is performed on the Prodigy within 10-14 days. Every required step is done automatically and can be scheduled by the customer in advanced, so virtually he has no hands on. I attached the link, where you can find more information and also download some graphical material. www.miltenyibiotec.com/applications/t-cells/gmp-engineered-t-cells.html
Hello jo mbu, if you are interested in our technology and instruments, please contact our MACS Service team for further questions: macstec@miltenyibiotec.de
![Automated manufacturing of CAR NK cells [WEBINAR]](http://i.ytimg.com/vi/6nKQRN_JyyY/mqdefault.jpg)
![Automated manufacturing of CAR NK cells [WEBINAR]](/img/tr.png)
How are the machine internals cleaned to prevent contamination from consecutive uses?
The CliniMACS Prodigy instrument works as part of a system using disposable, single- use closed Tubing sets in conjunction with the instrument's fluidic controls so that the contents being processed will not be exposed, remain sterile, and will not actually interact directly with the instrument.
www.miltenyibiotec.com/products/clinimacs-prodigy.html
Mind blowing 👍🏼
is the transduction step also done by the machine?
Hi Nat, yes the transduction is also done by CliniMACs prodigy. the viral vector can be sterilely connected to the tubing set. The user can flexibly decide when the cells should be transduced during the culture phase. He can program the activity "transduction" in the so called activity matrix and key in the volume of the vector as well as the time when the transduction should be performed. When the defined time is reached, the prodigy will ask the operator to connect the viral vector. Subsequently the vector will be transferred to the cells in the prodigy chamber automatically. If you have further question, please contact us directly www.miltenyibiotec.com
good system with high efficiency
Very cool, it seems that positive magnetic selection was done to isolate cells from apheresis product. Cells are then expanded but how do you purify the labeled cells from expanded cells? Do you require de-beading?
Dear Avanish, thank you for your question, no, our target cell preparations are not de-beaded.
Indeed, as a consequence of the labeling it is possible that Target cell preparations obtained by the processing through the CliniMACS System may contain residual amounts of the reagent bound enriched cells along with the expanded and manipulated cells. However, the safety of the iron/dextran formulation used for the manufacturing of the CliniMACS Reagents (these are bound to the cells) has been evaluated by a careful literature review and a detailed risk assessment was done including data gained and presented to the regulatory bodies. In our CAR-T process the amount of still labeled cells is further lowered through the performed manipulation and cell cultivation steps, when comparing to the complete target cell preparation at the end of the process. Overall the potential risk presented by the minimal amount of beads which may be injected in the patient along with the CAR-T cells is very minimal. Furthermore, since CliniMACS System first introduction to market in 1997, no side effects have been reported in the context with the iron dextran formulation. I hope this answers your question, please let me know if any supportive arguments are still required and if open questions still remained.
So does the cells remain in the prodigy system for 10-14 days if performing end to end?
Hi Madhu, the short answer is yes to both questions. The whole entire process from enriching the T-cells, Activate, transduce (engineer the T-Cells) and expand them is performed on the Prodigy within 10-14 days. Every required step is done automatically and can be scheduled by the customer in advanced, so virtually he has no hands on. I attached the link, where you can find more information and also download some graphical material. www.miltenyibiotec.com/applications/t-cells/gmp-engineered-t-cells.html
wow!!how much does this cost
Hello jo mbu, if you are interested in our technology and instruments, please contact our MACS Service team for further questions: macstec@miltenyibiotec.de
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