Clinimacs plus cell manufacturing platform products miltenyi. The userfriendly key components of the clinimacs plus instrument offer sophisticated applications for a whole variety of separations. Clinimacs plus cell manufacturing platform products. As a completely closed system process, that device offers the potential for graft engineering in health care. The clinimacs system has been in clinical use in europe since 1998, where it has consistently produced products that are highly depleted of cd31 t cells with good recovery of cd341. It was agreed that procedures described in the clinimacs users manual were to be strictly followed for the steps performed on the clinimacs. Only calculations performed by the clinimacs plus instrument have been validated.
Dec 02, 2016 at our instution we have explored the use of the clinimacs prodigy miltenyi biotec, inc for the production of cart cells. Both the clinimacs plus and prodigy normal scale cd34 selection modules specifications are up to 60. Harvest ready to give to patientcryopreserve october 5, 2016 clinimacs prodigy cart cells. The clinimacs plus instrument miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic. The treatment of cancer patients with autologous t cells expressing a chimeric antigen receptor car is one of the most promising adoptive cellular therapy approaches. Article details download article pdf view full text html 6. Magnetic selection or depletion of labelled target cells, for example from leukapheresis product, can be performed to.
Clinimacs user manual for the clinimacs cd34 reagent system. Pdf gmpcompliant manufacturing of nkg2d car memory t. The functioned print feature is printing the swf pages but not the real pdf pages, in this case it is suggested to download the pdf instead of printing swf pages so that you can get the best layout from original pdf. A cyclic process enables electroporation of multiple sample aliquots 500. Oct 10, 2019 in this study we developed a protocol to obtain largescale nkg2d car memory t cells for clinical use by using clinimacs prodigy, an automated closed system compliant with gmp guidelines. 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 pbsedta buffer, is fda approved as a humanitarian use device hud, authorized by u. Prodigy runs took about 1 h longer than clinimacs plus runs, albeit. A compact markersuicide gene reliant upon offtheshelf reagents would offer considerable utility for these adoptive cellular therapies. Federal law for use in the treatment of patients with acute myeloid leukemia aml in first. Clinimacs tubing set ts or large scale ls a singleuse, sterile, disposable tubing set with two proprietary cell separation columns. Clinimacs cd34 reagent package insert for more information. Prodigy runs took about 1 h longer than clinimacs plus runs, albeit with markedly less handson operator time and therefore also suitable for less experienced operators. Final product formulation change buffer concentration 8.
Three concurrent clinimacs plus and prodigy selection splitruns were performed. The new clinimacs system magneticactivated cell separation system by miltenyi biotech gmbh, bergischgladbach, germany was recently approved for clinical use in europe. This includes cookies that are technically required to ensure a proper functioning of the website, as well as cookies which are used solely for anonymous statistical purposes, for more comfortable website settings, or for displaying personalized content. A closed tubing system ensures sterile processing during the fully automated cell electroporation procedure.
The clinimacs plus instrument automates cell separation for clinicalscale enrichment of target cells or. Using the principles of macs technology, the clinimacs plus instrument figure 2 has been developed to permit the automated separation of cells on a clinicalscale level in a closed and sterile system. Clinical hematology international articles atlantis press. Recovery of target cells was the same for both technologies. For details on selections with clinimacs plus, please refer to the user handbook. Download free trials and updates for adobe products including creative cloud, photoshop, indesign, illustrator, acrobat pro dc, and many more.
Automation of cellular therapy product manufacturing. This protocol is designed to enable access to related or unrelated cd34 cells manufactured using the clinimacs miltenyi under the hud designation for patients needing t cell depleted allogeneic grafts for hematopoietic stem cell transplant hsct. This is an automated cell selection system for clinicalscale magnetic enrichment of target cells or for depletion of unwanted cells in a closed and sterile system. Automated manufacturing of chimeric antigen receptor t cells for adoptive immunotherapy using clinimacs prodigy. Clinimacs cd34 reagent system that would reduce t cells to the level that no posthpct pharmacological graftversushost disease gvhd prophylaxis was required. Clinical hematology international volume 1, issue 1, 1. The clinimacs prodigy is an automated device that can be used for cell processing within a closed gmpcompliant system. Accessgudid clinimacs plus instrument 04049934004636 the clinimacs plus instrument is a softwarecontrolled instrument that processes the hpc, apheresis as part of the clinimacs cd34 reagent system. The clinimacs electroporator is powered and controlled by the clinimacs prodigy.
Automation of cell therapy manufacturing promises higher productivity of cell factories, more economical use of highlytrained and costly manufacturing staff, facilitation of processes requiring manufacturing steps at inconvenient hours, improved consistency of processing steps and other benefits. At the end of your monthly term, you will be automatically renewed at the promotional monthly subscription rate until the end of the promo period, unless you elect to. Robust selections of various hematopoietic cell fractions. Pdf automated manufacturing of chimeric antigen receptor. Therefore, the results obtained from the use of the software must not be used as a basis for diagnosis or choice of treatment. Surmounting the developmental challenges of miltenyis. Clinimacs prodigy cell manufacturing platform products. Clinimacs plus upgrade kit software clinimacs plus. Frontiers gmpcompliant manufacturing of nkg2d car memory t. All except 1 of the studysite laboratories had previous training and experience using the clinimacs system before the trial started. Clinimacs plus instrument clinimacs plus instrument. For separation, a singleuse tubing set, including a separation column, is attached to the clinimacs instrument. Clinimacs reagents cell manufacturing platform products.
Natural killer cellmediated cellular therapy of hematological malignancies. 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 setup. Clinimacs cd34 reagent system fdaapproved downloads and. Download free adobe acrobat reader dc software for your windows, mac os and android devices to view, print, and comment on pdf documents. Download fulltext pdf automated manufacturing of chimeric antigen receptor t cells for adoptive immunotherapy using clinimacs prodigy article pdf available in cytotherapy 188. All selections were performed on a clinimacs plus instrument. For the majority of applications, clinical administration of treg requires laborious ex vivo expansion and typically involves open handling for culture feeds and repetitive sampling. Although semimanual and complex, the process is of sufficient robustness to consistently. Clinimacs plus instrument and accessories magnetic fields.
However, as a result of how donors for the validation study were selected, the tcell frequency was much lower by about half in the prodigy cohort. The clinimacs system enables depletion of a large number of cells with a single device in an acceptable amount of time. Isolation of highly purified autologous and allogeneic. Robust selections of various hematopoietic cell fractions on. Offer starts on jan 8, 2020 and expires on sept 30, 2020. Sep 03, 2019 the clinimacs plus instrument miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic progenitor. Clinimacs plus instrument principle clinimacs plus. Reagent 70146 and clinimacs plus system, both from. Clinimacs plus instrument regulatory status the usa, the system clinimacs available 2 for availability in your country contact for please refer to page i description the userfriendly key components of the clinimacss plus instrument offer cells are magnetic preparation bag u reagent. Adoptive transfer of t regulatory cells treg has been successfully exploited in the context of graftversushost disease, transplantation, and autoimmune disease.
The clinimacs plus instrument automates cell separation for clinicalscale enrichment of target cells or depletion of unwanted cells in a closed and sterile system. The clinimacs plus instrument miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic progenitor cells hpcs, t cells, nk cells, and monocytes. Cell separation technologies play a vital role in the graft engineering of hematopoietic cellular fractions, particularly with the rapid expansion of the field of cellular therapeutics. Using a singleuse tubing set, including a separation column, the device automatically applied the cell sample to the separation column, performs multiple washing steps, and elutes. Comparative schedules of the cd34 selection process with clinimacs plus and clinimacs prodigy. Download a free trial or buy adobe products adobe free.
Using the principles of macs technology, the clinimacs plus instrument figure 2 has been developed to permit the. One of the most broadly disseminated engineered cell therapy products is. Sep 27, 2016 clinimacs hud for t cell depletion the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Federal law for use in the treatment of patients with acute myeloid leukemia aml in first complete remission. Product quality needs to be builtin within every step of the manufacturing process. The clinimacs plus instrument has been developed to allow the automated separation of cells on a clinicalscale level in a closed and sterile system.
Refer to the clinimacs user manual for the cd34 is chemically conjugated to dextran beads having an. Article details download article pdf view full text html 2. Automated cd34d cell isolation of peripheral blood stem cell apheresis. Find highquality images, graphics, videos, 3d assets, templates, and more. Prodigy runs took about 1 h longer than clinimacs plus runs, albeit with markedly less.
Cart cell production using the clinimacs prodigy system. Additionally, patient and instrumentrelated factors affecting these parameters were examined. Reproducible manufacturing of highquality, clinicalgrade cart cell products is a prerequisite for the wide application of this technology. The regular monthly price for adobe acrobat pdf pack is mo plus applicable taxesvatgst. L in a row, from a cell suspension with a total volume of up to 50. The clinimacs prodigy miltenyi biotec has recently been adapted for lentiviral transduction of t cells and here we analyse the feasibility of a clinically compliant tcell engineering process for the manufacture of t cells encoding chimeric antigen receptors car for cd19 car19, a widely targeted antigen in bcell malignancies. Clinimacs plus instrument a software controlled instrument that processes the hpc, apheresis. Thank you for using the download pdf file feature, to.
Gmpcompliant manufacturing of nkg2d car memory t cells using clinimacs prodigy. Process time is similar for both protocols, but handson time with prodigy is much reduced. Download free acrobat reader dc software, the only pdf viewer that lets you read, search, print, and interact with virtually any type of pdf file. The effectiveness of the device for this use has not been. At the start of the selection processes, apheresis products were 2044 h old. Using the cart system that includes software, specialized tubing sets, and optimized reagents. Clinimacs prodigy is the most recent device in this succession. Depletion of tcell receptor alphabeta and cd19 positive cells from apheresis products with the clinimacs device.
Pdf automated manufacturing of chimeric antigen receptor t. Automated manufacturing of chimeric antigen receptor t. It delivers consistent product quality in every batch enabling reproducible cell production. Apply and request unlimited electronic signaturesgiving you the power to accelerate daily tasks and. Listing a study does not mean it has been evaluated by the u. The selected stem cells, monocytes, dcs, nk cells, b cells, and t cell subsets allow research in the field of regenerative medicine, adoptive immunotherapy, and graft engineering. The clinimacs plus instrument enables clinicalscale separations for a variety of cells, including hematopoietic stem cells, mesenchymal stem cells, monocytes, dcs, nk cells, b cells, and t cell subsets, for use in the fields of regenerative medicine, adoptive immunotherapy, and graft engineering.
Magnetic selection or depletion of labelled target cells, for example from leukapheresis, can be performed to isolate a desired cell population or for the specific removal of a given cell. The clinimacs plus instrument miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic progenitor. Depletion of tcell receptor alphabeta and cd19 positive. We use cookies in order to provide the best possible website experience for you. The clinimacs plus instrument is a softwarecontrolled instrument that processes the hpc, apheresis as part of the clinimacs cd34 reagent system. Pdf closedsystem manufacturing of cd19 and dualtargeted. Robust selections of various hematopoietic cell fractions on the. Clinimacs system immunomagnetic cell separation ecr journal. T cells 1 which no longer requires manual addition of peptide reagent. Cancer immunotherapy represents a rapidly developing field with potential to address shortcomings from current therapies. Cell cultivation media addition and removal supplement addition 7.
Characteristics of clinimacs system cd34enriched t cell. Clinimacs plus 12, prodigy successively and fully automatically performs platelet washes, cd34 abnanobead conjugate incubation, immunomagnetic column selection and cell elution. Forum on vaccine science customer reports generation of tumorinfiltrating lymphocyte cultures for adoptive therapy clinicalgrade purification and expansion of. Download fulltext pdf closedsystem manufacturing of cd19 and dualtargeted cd2019 chimeric antigen receptor t cells using the clinimacs prodigy device at an academic medical center.
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