For separation, a singleuse tubing set, including a separation column, is attached to the clinimacs instrument. The tct process on the clinimacs prodigy in combination with the ts520 was used for the entire process. The clinimacs prodigy offers a flexible platform for cell processing applications enabling the magnetic separation of different cell types as well as customized cell processing protocols. Activation, transduction, and expansion were conducted in clinimacs prodigy. Formulation and preparing the dose is a complicated process for many people. Isolation of cd20positive cells from human leukapheresis product date modified. Dual targeted cd2019 cart cell production using the.
Interview optimizing cellbased product consistency. The cell processing unit for fully automated washing, fractionation and cultivation of cells represents an integral component of the device. The clinimacs prodigy customized application service. Product quality needs to be builtin within every step of the manufacturing process. Comparing the performance of the prodigy with the clinimacs ccs procedure will yield information on the viability, purity, and recovery of the enriched tcell products. Understanding todays cart cell therapy manufacturing challenges. The clinimacs plus and prodigy devices 5 9 10, 3, clinimacs ts and prodigy ts310 tubing sets, clinimacs cd34 reagent 1 vial each and clinimacs pbsedta buffer were obtained from miltenyi biotec bergischgladbach, germany.
It delivers consistent product quality in every batch enabling reproducible cell production. The development of car t cell therapy has now expanded beyond phase 1 trials and moved into phase 2 multisite trials nct02435849 and nct02228096, and a major consideration for academic institutions and industry is how to scale out the production of car t cells in an efficient, effective manner. 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. Request pdf on mar 1, 2019, fenlu zhu and others published automated manufacturing of cd20. For leukapheresis products, the clinimacs prodigy instrument and ts310 were used for automated tcell receptor tcr. Taken together, our results indicate that the clinimacs prodigy system is suitable for clinical treg manufacturing in terms of cell yield and phenotype. Since its introduction in 1997 the clinimacs cell separation system.
Download pdf journal of translational biomed central. We are looking to solve this problem by creating another device and some software for the clinimacs prodigy to automatically formulate. Here we describe the process of manufacturing car t cells, and we discuss. The clinimacs prodigy with tct process software and the ts520 tubing set that allows closedsystem processing for cell enrichment, transduction, washing and expansion was used. Surmounting the developmental challenges of miltenyis. Peter jahn and his webinar on the clinimacs prodigy platform, including features, benefits, and workflow examples. Clinimacs, prodigy cobe 2991, cell saver 5, lovo, elutra, sepax, prodigy aapcs, dynabeads, expact treg beads, transact beads, expamer retroviral and lentiviral vectors transposontransposase mrna electroporation wave, grex, cell culture bag, prodigy cobe 2991, cell saver 5, lovo, sepax, prodigy controlledrate freezer infusion apheresis product. Clinimacs plus instrument and accessories magnetic fields. Cells were produced by the clinimacs prodigy ccs ifngamma system within 24 hours after mononuclear leukapheresis. The entire manufacturing process, as well as the subsequent quality control of the final cell product cp, were realized onsite and in compliance with eu guidelines for good manufacturing practice.
Early experience with clinimacs prodigy ccs ifngamma. T cells are collected from a cancer patients blood and genetically engineered to produce receptors called. The clinimacs prodigy system offers an allinone solution for cell processing in a closed good manufacturing practice gmp compliant system, while the lovo cell processing system automates the laborintensive tasks of separation, washing, plateletdepletion, fluidexchange, and concentration of living cells. The clinimacs prodigy jason jones manager, cell therapy and therapeutic apheresis. Further automated cd56 enrichment with the use of the instrument was achieved by means of program enrichment 1, clinimacs cd56 reagent and tubing set ts100. Heimfeld laboratory at the fred hutchinson cancer research center. Prodigy has recently been shown to successfully produce car tcell products at different facilities, demonstrating its potential. 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.
Title page automated manufacturing of cart cells for. Automated manufacturing of potent cd20directed chimeric antigen receptor t cells for clinical use dominik lock,1,nadine mockeltenbrinck,1,katharina drechsel,1 carola barth,1 daniela mauer,1 thomas schaser,1 carolin kolbe,1 wael al rawashdeh,1 janina brauner,1 olaf hardt,1 natali p. Clinimacs prodigy t cell transduction miltenyi biotec. Miltenyi biotec gmbh innovative medicines initiative. A closed tubing system ensures sterile processing during the fully automated cell electroporation procedure. Reproducible manufacturing of highquality, clinicalgrade cart cell products is a prerequisite for the wide application of this technology. Prodigy owners manual 27 prodigy diabetes care, llc 1. Six patients are alive without viral illness or sequelae demonstrating viral dna clearance in peripheral blood with a median followup of 535 350. Contribute to micmacigndocumentation development by creating an account on github.
The clinimacs prodigy system photo 1 from miltenyi biotec is a platform that automatically performs making cart cell immunotherapies work by mazen w. 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. Automated cell processing with the clinimacs prodigy. Clinimacs prodigy principle clinimacs prodigy cell. Upon selection of the tct application program, all parameters of stimulation, washing, and feedings used in the current study are available to the user as preloaded conditions.
There are plenty of problems in the term and the community kind of avoids fixingta. Characteristics of clinimacs system cd34enriched t celldepleted grafts in a multicenter trial for acute myeloid leukemiablood and marrow transplant clinical trials network bmt ctn protocol 0303. Automation of cellular therapy product manufacturing. Automated cell processing with the clinimacs prodigy usa. With our practice labs for microsoft we cover a range of operating system versions and enterprise software. Mar 16, 2016 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. Automated manufacturing of potent cd20directed chimeric. Prodigy for clinical applications used for adoptive t cell therapy. One of the newest technologies being explored for cart cell expansion is the miltenyi clinimacs prodigy system. Miltenyi biotec is a global biotechnology company headquartered near cologne in bergisch gladbach, germany. Pdf gmpcompliant manufacturing of nkg2d car memory t.
Automated enrichment, transduction, and expansion of. T lymphocytes are exhibiting enormous potential in early phase clinical trials in patients with haematological malignancies. Pdf characteristics of clinimacs system cd34enriched t. Adoptive immunotherapy has shown the most promise in recent years, with particular emphasis. Eight patients became completely asymptomatic, whereas 7 also cleared the virus. Additional licenses you are entitled to use complete dynamics on more that one computer that you own. However, the complex procedures involved in the exvivo modification of t cells is labour intensive and currently limited to a small number of centres with the required infrastructure and expertise. However, a fully automated gmpcompliant separation and expansion of clinicalgrade nk cells at sufficiently high effector cell numbers remains a great challenge. This system is currently used for stem cell enrichment and virusreactive tcell preparation. Database with this powerful database of information, you can analyze sales trends, choose how you want to view information, calculate commissions and customize reporting to meet your unique needs. This gmpcompliant device offers advanced integrated solutions to streamline cellprocessing workflows. The second part of the webinar focuses on the customized application. Reduced intensity conditioning will include busulfan, fludarbine, cyclophosphamide followed by stem cell infusion. From analyzing sales, to paying sales reps and tracking commissions, dynamacs is a comprehensive software designed specifically for sales agencies.
To simplify procedures and widen applicability for clinical therapies. Recently, the fully automated clinimacs prodigy system, which can be used for both cell selection and culture, has been shown to compare favorably with the clinimacs plus instrument in regards to. Clinimacs devices provide stable cell separation technology and the most advanced member of this product line, the clinimacs prodigy, enables automated. Pretransduction cell processing cell washing clinimacs cell separation 4. Fewer manual processing steps and reduced cleanroom requirements are the key to costeffective cell product manufacturing. One of the most broadly disseminated engineered cell therapy products is. Reagents patient sample sterile connection for vector 3. The clinimacs prodigy represents the next generation in automated cell processing. Development of automated separation, expansion, and.
These expansion data are in line with other manufacturing protocols using clinimacs prodigy 43, 44. A breakthrough approach for cancer patient 21 november 2017 news clinimacs prodigy system gives cancer patient hope for unmatched bone marrow transplant, car t cells, dc cell, nk cells as per the analysis, doctor says that 70% of blood cancer patients were left with no donors. These include microsoft windows server 2008 r2, 2012 r2, microsoft windows desktop 8. Generation of cart cell products using manual processes are complex and difficult to. If you want to use computer interface to program and operate, you can order 0001516 interface adapter. 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. Prodigy advance2 is simple enough for the firsttime user to quickly master, yet has sophisticated functionality that will impress the. Note the prodigy wireless does not support nondecoder equipped or analog locos. Clinimacs system immunomagnetic cell separation ecr journal.
However, running analog locos will dramatically slow the response time of your dcc system. The company is a provider of products and services that support scientists, clinical researchers, and physicians across basic research, translational research, and clinical applications. Right now, the clinimacs prodigy can fully automate the production of up to 5 billion cells using the tcell transduction process. You can use all three methods of expansion and up to 4 handhelds working at same time. Automated manufacturing of chimeric antigen receptor t cells. Cell therapy has proven to be a burgeoning field of investigation, evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. Gmpcompliant manufacturing of nkg2d car memory t cells. The clinimacs cell selection system, based upon macs technology, takes magnetic cell separation one step further, providing a closed, sterile system for the enrichment of specific cell populations that can subsequently be used in clinical research applications.
Miltenyi biotec gmbh, bergisch gladbach, germany according to the manufacturers recommendation. Insert the batteries open the battery cover located on the backside of the meter. Mrcs earlier dcc systems do support running analog locos. Lowell middlesex academy charter school 2 table of contents mission statement 3 teaching and learning at lmacs 4. T cell therapy of opportunistic cytomegalovirus infection.
They enable sample preparation, separation, genetic modification, and cultivation of cells from a variety of sample sources for bioprocessing. Many cell therapies have been shown to be efficacious in humans, such as modified tcells and natural killer nk cells. There is a new device availablethe clinimacs prodigy miltenyi biotecwhich is capable of performing automatically all these steps. Rapid generation of clinicalgrade antiviral t cells. Automated manufacturing of chimeric antigen receptor t cells for. Listing a study does not mean it has been evaluated by the u. The mobile phase consisted of 55 mm sodium acetate, 1 mm octanesulfonic acid, 0. Clinimacs prodigy cell manufacturing platform products.
However, if you replace the batteries, you should check the time and date. Reagents, tubing sets, and buffers are purchased from miltenyi biotec. Clinimacs prodigy system, hereafter referred to as prodigy, is a selfcontained, closed, and largely automated device that obviates the need for human involvement in numerous steps, reducing human resource utilization and the risk of cell contamination figure 1. As we have shown, clinimacs prodigy is unconditionally suitable to perform the cd34 selection process.
Dec 16, 2014 the use of the fully automated clinimacs prodigy miltenyi biotec might overcome these problems by e. Cerebral 5ht release correlates with 11ccimbi36 pet. Isolation of cd20positive cells from human leukapheresis product 1 sop. Gmpcompliant manufacturing of nkg2d car memory t cells using clinimacs prodigy article pdf available in frontiers in immunology 10. This is the first report on the cd34 selection process on clinimacs prodigy. Page 1 chamsys ltd uk magicq user manual patching, programming and playback of shows using generic lighting, moving lighting, led and media servers. Fully automated expansion and activation of clinicalgrade. Automated manufacturing of chimeric antigen receptor t cells for adoptive immunotherapy using clinimacs prodigy. Automated clinical grade expansion of regulatory t cells. They provide a closed and sterile fluid path and the functional.
One of the most broadly disseminated engineered cell therapy products is immunomagnetically. Automated manufacturing of chimeric antigen receptor t cells for adoptive immunotherapy using clinimacs prodigy article pdf available in cytotherapy 188. L in a row, from a cell suspension with a total volume of up to 50 ml. Using the cart system that includes software, specialized tubing sets, and optimized reagents we demonstrate the processing of cart cells, with similar characteristics to those produced in a more traditional manner, in a. Design, synthesis, radiolabeling and in vivo evaluation of. Since its introduction in 1997, the clinimacs cell separation system has become a proven technology for the development and establishment of cell. The internal layout is an early example of the french and italian style of grouping rooms into selfcontained suites, a departure from the medieval style of corridor rooms. Dec 06, 2016 t cell therapy of opportunistic cytomegalovirus infection the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Therefore, our new prodigy wireless does not support this old feature.
After purchasing a license, we can send you additional licenses for your other computers. Characterization of clinical grade cd19 chimeric antigen. Clinimacs prodigy expanded treg of the same isolated batches were of 92. The clinimacs prodigy tubing sets are a key component of the clinimacs prodigy system. Pdf automated manufacturing of chimeric antigen receptor. A fullyfunctional, affordable dcc system thats easy to useif youve put off the change to digital command control dcc because you thought it was too complicated or expensive, then mrcs prodigy advance2 is the system for you. As the clinical gmp compliant automat clinimacs prodigy is being programmed to perform ever. The clinimacs prodigy device, prodigy ts310 tubing sets, clinimacs cd34 reagent 2 vials and clinimacs pbsedta buffer were received from miltenyi biotec. Optimizing cellbased product consistency through automation. Generate genemodified t cells in a simple and automated fashion. Specific structural modifications were performed in order to maintain affinity for the target receptor and to improve the selectivity over 5ht 1a and. The cell processing unit for fully automated washing, fractionation and cultivation of cells represents an. The company offers solutions buzzword covering techniques of sample preparation, cell separation.558 705 1447 983 1276 649 1516 484 526 280 169 344 611 714 71 242 1273 754 735 973 1092 102 1285 949 1059 280 356 925 830 1079 545 824 678 469 225 1331 1258 144 1116 1498 739 189 763 584 567