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. Clinimacs prodigy cell manufacturing platform products. Magnetic selection or depletion of labelled target cells, for example from leukapheresis product, can be performed to. All except 1 of the studysite laboratories had previous training and experience using the clinimacs system before the trial started. The clinimacs plus instrument automates cell separation for clinicalscale enrichment of target cells or depletion of unwanted cells in a closed and sterile system. L in a row, from a cell suspension with a total volume of up to 50. Clinimacs cd34 reagent system that would reduce t cells to the level that no posthpct pharmacological graftversushost disease gvhd prophylaxis was required. Clinimacs plus upgrade kit software clinimacs plus.
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. Using the cart system that includes software, specialized tubing sets, and optimized reagents. Only calculations performed by the clinimacs plus instrument have been validated. Automation of cellular therapy product manufacturing. As a completely closed system process, that device offers the potential for graft engineering in health care. At the start of the selection processes, apheresis products were 2044 h old. For details on selections with clinimacs plus, please refer to the user handbook. Apply and request unlimited electronic signaturesgiving you the power to accelerate daily tasks and. 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. All selections were performed on a clinimacs plus instrument. Surmounting the developmental challenges of miltenyis.
The new clinimacs system magneticactivated cell separation system by miltenyi biotech gmbh, bergischgladbach, germany was recently approved for clinical use in europe. 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. Prodigy runs took about 1 h longer than clinimacs plus runs, albeit. The clinimacs plus instrument automates cell separation for clinicalscale enrichment of target cells or. A cyclic process enables electroporation of multiple sample aliquots 500.
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. Characteristics of clinimacs system cd34enriched t cell. Frontiers gmpcompliant manufacturing of nkg2d car memory t. 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. The clinimacs plus instrument miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic. Thank you for using the download pdf file feature, to. Gmpcompliant manufacturing of nkg2d car memory t cells using clinimacs prodigy. Comparative schedules of the cd34 selection process with clinimacs plus and clinimacs prodigy.
Pdf gmpcompliant manufacturing of nkg2d car memory t. 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 electroporator is powered and controlled by the clinimacs prodigy. Clinimacs tubing set ts or large scale ls a singleuse, sterile, disposable tubing set with two proprietary cell separation columns. Automated manufacturing of chimeric antigen receptor t cells for adoptive immunotherapy using clinimacs prodigy. Prodigy runs took about 1 h longer than clinimacs plus runs, albeit with markedly less. Using the principles of macs technology, the clinimacs plus instrument figure 2 has been developed to permit the. 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. Federal law for use in the treatment of patients with acute myeloid leukemia aml in first complete remission.
The clinimacs system enables depletion of a large number of cells with a single device in an acceptable amount of time. Clinimacs plus instrument principle clinimacs plus. Cell cultivation media addition and removal supplement addition 7. Clinimacs user manual for the clinimacs cd34 reagent system. Clinimacs plus cell manufacturing platform products.
The clinimacs plus instrument miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic progenitor cells hpcs, t cells, nk cells, and monocytes. The clinimacs prodigy is an automated device that can be used for cell processing within a closed gmpcompliant system. It delivers consistent product quality in every batch enabling reproducible cell production. Clinimacs cd34 reagent package insert for more information. Harvest ready to give to patientcryopreserve october 5, 2016 clinimacs prodigy cart cells. Listing a study does not mean it has been evaluated by the u. Refer to the clinimacs user manual for the cd34 is chemically conjugated to dextran beads having an. Although semimanual and complex, the process is of sufficient robustness to consistently. Find highquality images, graphics, videos, 3d assets, templates, and more. Clinimacs reagents cell manufacturing platform products. Download free trials and updates for adobe products including creative cloud, photoshop, indesign, illustrator, acrobat pro dc, and many more. The regular monthly price for adobe acrobat pdf pack is mo plus applicable taxesvatgst. Cancer immunotherapy represents a rapidly developing field with potential to address shortcomings from current therapies. The userfriendly key components of the clinimacs plus instrument offer sophisticated applications for a whole variety of separations.
One of the most broadly disseminated engineered cell therapy products is. Pdf closedsystem manufacturing of cd19 and dualtargeted. Depletion of tcell receptor alphabeta and cd19 positive. Dec 02, 2016 at our instution we have explored the use of the clinimacs prodigy miltenyi biotec, inc for the production of cart cells. 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.
Additionally, patient and instrumentrelated factors affecting these parameters were examined. 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. The clinimacs plus instrument has been developed to allow the automated separation of cells on a clinicalscale level in a closed and sterile system. 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. A closed tubing system ensures sterile processing during the fully automated cell electroporation procedure. Depletion of tcell receptor alphabeta and cd19 positive cells from apheresis products with the clinimacs device.
Process time is similar for both protocols, but handson time with prodigy is much reduced. Clinimacs plus instrument and accessories magnetic fields. Download a free trial or buy adobe products adobe free. 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. Pdf automated manufacturing of chimeric antigen receptor. 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. A compact markersuicide gene reliant upon offtheshelf reagents would offer considerable utility for these adoptive cellular therapies. 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. Isolation of highly purified autologous and allogeneic. Clinical hematology international volume 1, issue 1, 1. The effectiveness of the device for this use has not been.
Both the clinimacs plus and prodigy normal scale cd34 selection modules specifications are up to 60. Clinimacs plus instrument a software controlled instrument that processes the hpc, apheresis. Federal law for use in the treatment of patients with acute myeloid leukemia aml in first. Clinimacs plus cell manufacturing platform products miltenyi. Cart cell production using the clinimacs prodigy system. The clinimacs plus instrument is a softwarecontrolled instrument that processes the hpc, apheresis as part of the clinimacs cd34 reagent system. 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. Offer starts on jan 8, 2020 and expires on sept 30, 2020. 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. Pdf automated manufacturing of chimeric antigen receptor t. Final product formulation change buffer concentration 8.
Automated manufacturing of chimeric antigen receptor t. T cells 1 which no longer requires manual addition of peptide reagent. 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. Three concurrent clinimacs plus and prodigy selection splitruns were performed. 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. Clinimacs system immunomagnetic cell separation ecr journal. 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. For separation, a singleuse tubing set, including a separation column, is attached to the clinimacs instrument. 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. 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. Reproducible manufacturing of highquality, clinicalgrade cart cell products is a prerequisite for the wide application of this technology.
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. 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. 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. Clinimacs plus instrument clinimacs plus instrument. Download free adobe acrobat reader dc software for your windows, mac os and android devices to view, print, and comment on pdf documents. Forum on vaccine science customer reports generation of tumorinfiltrating lymphocyte cultures for adoptive therapy clinicalgrade purification and expansion of. 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 miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic progenitor. Clinimacs prodigy is the most recent device in this succession. Sep 03, 2019 the clinimacs plus instrument miltenyi biotec utilizes immunomagnetic techniques to isolate hematopoietic progenitor. Natural killer cellmediated cellular therapy of hematological malignancies. 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. Reagent 70146 and clinimacs plus system, both from. Therefore, the results obtained from the use of the software must not be used as a basis for diagnosis or choice of treatment. Download fulltext pdf automated manufacturing of chimeric antigen receptor t cells for adoptive immunotherapy using clinimacs prodigy article pdf available in cytotherapy 188. It was agreed that procedures described in the clinimacs users manual were to be strictly followed for the steps performed on the clinimacs.
Article details download article pdf view full text html 2. Robust selections of various hematopoietic cell fractions on the. We use cookies in order to provide the best possible website experience for you. Clinical hematology international articles atlantis press. Robust selections of various hematopoietic cell fractions.
Clinimacs plus 12, prodigy successively and fully automatically performs platelet washes, cd34 abnanobead conjugate incubation, immunomagnetic column selection and cell elution. 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. Automated cd34d cell isolation of peripheral blood stem cell apheresis. Recovery of target cells was the same for both technologies. Robust selections of various hematopoietic cell fractions on. Frontiers automated clinical grade expansion of regulatory. Product quality needs to be builtin within every step of the manufacturing process. Clinimacs cd34 reagent system fdaapproved downloads and. Full system control by means of an integrated microcomputer automatized cell. Automated cd34d cell isolation of peripheral blood stem cell apheresis product gabriele spohn1, eliza wiercinska1, darja karpova2. Article details download article pdf view full text html 6.