Automated CAR T cell manufacturing

Learn more about the CliniMACS Prodigy www.miltenyibiotec.com/produc... With the CliniMACS Prodigy® T Cell Transduction Process you can now manufacture CAR T cells in a simple and fully automated fashion. The CliniMACS Prodigy® is able to perform cell enrichment, activation, genetic manipulation, and expansion with minimal involvement from the user. All steps take place in a closed system, providing a sterile solution for the challenges associated with clinical-grade CAR T cell production. All reagents for cell enrichment and activation as well as cytokines and media are available in MACS® GMP quality.
The advantages of the CliniMACS Prodigy for the clinical-scale production of CAR T cells:
• automated CAR T cell production
• minimal hands-on-time from the operator
• sterile expansion in a single-use closed system
• supports both local and large scale production of CAR T cells
• standardized process for robust and consistent results
Learn more about the advantages of our automated CAR T cell manufacturing process www.miltenyibiotec.com/applic...
Learn more about the CliniMACS Prodigy www.miltenyibiotec.com/produc...
Understand how the CliniMACS Prodigy works www.miltenyibiotec.com/produc...
Miltenyi Biotec is a global provider of products and services that advance biomedical research and cellular therapy. The company is committed to enable commercial scale cell and gene therapy for the delivery of new treatment options to patients with unmet medical need. The company’s state-of-the-art technologies and products provide integrated workflows for research and clinical applications and have set a new industry standard in automated manufacturing of complex cellular products such as CAR T cells, TCR-transduced T cells, and gene-modified stem cells. Miltenyi Biotec’s portfolio of instruments, reagents and disposables is complemented with contract development and cGMP manufacturing services for lentiviral vectors and cellular products based on the company’s unique platforms for cell processing and cellular analytics. Miltenyi Biotec has more than 2,500 employees in 28 countries and its products have been used in more than 50,000 cell therapy procedures. For more information please visit www.miltenyibiotec.com

[@ahmadjoshkon]

Mind blowing 👍🏼

[@kailinyang8106]

good system with high efficiency

[@guillaume6373]

How are the machine internals cleaned to prevent contamination from consecutive uses?

[@Miltenyi_Biotec]

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

[@avanishmishra4768]

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?

[@Miltenyi_Biotec]

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.

[@Nat-og5jd]

is the transduction step also done by the machine?

[@Miltenyi_Biotec]

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

[@madhumathi3233]

So does the cells remain in the prodigy system for 10-14 days if performing end to end?

[@Miltenyi_Biotec]

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

[@jombu5001]

wow!!how much does this cost

[@Miltenyi_Biotec]

Hello jo mbu, if you are interested in our technology and instruments, please contact our MACS Service team for further questions: [e-mail]

[@user-rb9jg4lq1w]

有利為病人服務