It enables the operator to perform large-scale magnetic … and human serum albumin (HSA) were from Bax-ter (Unterschleißheim, Germany). The CHOP Stem Cell Lab has extensive prior experience with automated cell processing technologies, including the CellPro Ceprate device and the Isolex 300i. CliniMACS® Plus User Manual for the CliniMACS CD34 Reagent System Software version 2.41 Issued: 2020-07 37070/02 HUMANITARIAN DEVICE: Authorized by U.S; Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission; The effectiveness of the device for this indication has not been demonstrated. In this study, we translated our cytokine-based culture protocol for ex vivo expansion of NK cells … Priming of TS . CliniMACS Plus Instrument is an automated cell separation device based on MACS Technology. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while … CliniMACS newsletter 2011 1. Day 0: Installation of tubing sets (TS 520 + EP-2), integrity test and priming after attachment of supplemented CliniMACS PBS/EDTA … The collected cell fraction was bead depleted on the CliniMACS ® Plus device before manual final formulation. Hands on. The CliniMACS Plus semi-automatic instrument from Miltenyi Biotec has been used for decades for clinical-scale enrichment of CD34+ cells in a closed and sterile system. Miltenyi Biotec have developed a commercially available T-Cell Transduction (TCT) process for use on their CliniMACS Prodigy™. The effectiveness of the device for this indication has not been demonstrated. Using the CliniMACS Plus Del Fante and colleagues have found a very similar level of CD19+ cells depletion; 3.5 to 3.6 log-depletion 14. 20 cm for holder of bar code reader and MACS® TubeSealer) Depth: 40 cm housing Height: 48 cm housing (plus max. 130-097-182. Manual steps. 1/2011 CliniMACS® Products and applications • New MACS® GMP CD3 and CD28 antibodies • Cell Culture Bags Meeting minutes • Stem Cell Meeting Cologne 2010 • DC2010: Forum on Vaccine Science Customer reports • Generation of tumor-infiltrating lymphocyte cultures for adoptive therapy • … The manual preparation process for CliniMACS Plus selection involves repeated centrifugation, supernatant depletion, wash buffer addition, and cell resuspension steps, as well as many welding and sealing steps to connect and remove waste and buffer bags. Miltenyi Biotec GmbH. CCR5 -edited CD4 + -T cells are manufactured during a 12-day process after single installation of a fused tubing set. The recovery and purity of CD34+ cells was comparable to the CliniMACS Plus but depletion of T and B-cells was found to be lower on the Prodigy compared to the CliniMACS Plus. This prospective study was carried out in healthy donors and patients. NaCl 0.9 %, H 2 O ad. The CliniMACS ® Prodigy is an automated device that can be used for cell processing within a closed GMP-compliant system. Newsletter Vol. 11 No. 11 No. life of human beings. The wafers used by the TSCD-II welder heat up to 300 ̊C, maintaining sterility during cutting and welding without allowing particulates or chemical residue to form in the tubes. 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. Open steps. Comparative schedules of the CD34 selection process with CliniMACS Plus and CliniMACS Prodigy. Software is provided on an "as is" basis without any warranty. inj. It enables the operator to perform large-scale magnetic cell selection in a closed and sterile system (Fig. Automated Treg expansion was conducted in parallel to an established manual manufacturing process using G-Rex cell culture flasks. Preview. The CliniMACS System for research use combines manual and automated 700-29. Related manuals . These steps require significant operator interac-tion and careful monitoring (i.e., to Equal distribution of the culture was examined by cell counting. secreting T cells using the CliniMACS. CliniMACS® Plus System User Manual (Canadian edition) 1 – 2. 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 PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device (HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. Mobilized PBSC will be processed using the CliniMACS system for TCR alpha/beta+ T cell depletion plus CD19+ B cell depletion. of peripheral blood stem cell apheresis product with a semi-manual vs. an automatic procedure. Find many great new & used options and get the best deals for Miltenyi Biotec Clinimacs Plus Instrument Clinical-scale Cell Selection Manufact at the best online prices at eBay! CliniMACS® Plus User Manual for the CliniMACS CD34 Reagent System Software version 2.41 Issued: 2020-07 37070/02 HUMANITARIAN DEVICE: Authorized by U.S; Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission; The effectiveness of the device for this indication has not been demonstrated. 2. As the clinical GMP-compliant automat CliniMACS Prodigy is being programmed to perform ever more complex sequential manufacturing steps, we developed a CD34+ selection module for comparison with the standard semi-automatic CD34 “normal scale” selection process on CliniMACS Plus, applicable for 600 × 10 6 target cells out of 60 × 10 9 … In addition, large vs. normal scale column and manual vs. automated washing systems were also compared. Februar 6, 2014 Anne Richter // R&D Reagent Department // AMC Page 18 . Reformulation of end product. Operator – minimise potential exposure to agents. Preparation . Common Quality. Three concurrent CliniMACS Plus and Prodigy selection split-runs were performed; all were successful in that they proceeded without issues and generated highly pure CD34 products. Plus Instrument, CliniMACS Tubing Sets for Research Use , CliniMACS MicroBeads, and CliniMACS PBS/EDTA Buffer for Research Use. 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 PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device (HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. To the funest extend permitted by applicable law, Miltenyi Biotec expressly Miltenyi Biotec GmbH. Prodigy system. Mobilized PBSC will be processed using the CliniMACS system for TCR alpha/beta+ T cell depletion plus CD19+ B cell depletion. The study will determine efficacy of this strategy in terms of engraftment, rates of acute and chronic Graft versus Host Disease (GvHD), and one year overall and event-free survival. o ABMT-GEN-014 Data Management. CliniMACS® Cell Separation System, Product catalog 2008 CD34 Reagent System - Atlanta Pediatric Research MACS®-4-omics - Miltenyi Biotec CD4+CD25+ Regulatory T Cell Isolation Kit MACS® Chill Racks specification for autolabeling CD34 MicroBead Kit Free shipping for many products! As outlined on page 147 of the CliniMACS® Plus System User Manual (Canadian Edition) issued in June 2020: “The CliniMACS® PBS/EDTA Buffer does not have to be removed before administration of the separated target cells if the volume does not exceed 100 mL per transplant at appropriate infusion rates. Download. 500. o APBMT-COMM-027 Adult and Pediatric Blood and Marrow Transplant Program Quality Management Plan. CliniMACS Plus •The Prodigy offers a single device for CD34 cell selection, unlike the CliniMACS Plus which requires other equipment •The Prodigy process is fully automated and this translates into a reduction in the time required of experienced laboratory staff •Our results suggest that the Prodigy can be used for the routine o APBMT-COMM-028 Performance Improvement Plan and Reporting. This site helps .... 38z manual 2 cell separator w operations manual cobe 2991 20dt outboard cobe spectra operators manual compiled pdf, doc, weigh tronix service manual used .... 2013. 1 Miltenyi Biotec has recently developed a successor to the CliniMACS Plus, the CliniMACS Prodigy, which is a fully automated device with limited operator involvement. The design enables fast, one-handed operation, and durable materials stand up to intensive use. CIDO (Cercador d'Informació de Diaris Oficials) / El CIDO és l'eina imprescindible per accedir a la informació publicada als diaris i butlletins oficials o als webs que afecten l'àmbit territorial català cido Subministraments public 07/08/2014 23/11/2021 17:21:26 Sant Feliu de Llobregat Always refer to the Information provided by the CliniMACS plus Instrument or the CliniMACS Manual. 70 kg (excluding weight of attached fluids and accessories) 0.5 h . The user-friendly key components of the CliniMACS® Plus Instrument offer sophisticated applications for a whole variety of separations. This device offers advanced integrated solutions to streamline cell 7 Jun 2012 CliniMacs has more variety of clinical grade antibody conjugates (i.e. Techniques: Isolation, Cell Culture, Flow Cytometry, Cytometry The system enables the operator to perform large scale magnetic enrichment of target cells, or depletion of unwanted cells, in a closed and sterile system. The mean log depletion of CD19+ cells was 3.03±0.28 for the Prodigy compared to 3.62±0.30 for the CliniMACS Plus. The quality of the products generated is similar to products generated with CliniMACS Plus. Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory SOPs and using aseptic technique. Table of Contents: Standard Operating Procedures. It runs fully automatically beyond set-up and thus markedly reduces labor. The CliniMACS Plus Instrument has been developed to allow the automated separation of cells on a clinical-scale level in a closed and sterile system. Critically this system encompasses end-to-end processing on one automated platform, although cell expansion is limited by the size of the culture chamber. 4 h . The CliniMACS Plus and Prodigy devices [5 9 10], 3, CliniMACS TS and Prodigy TS310 tubing sets, Clini-MACS CD34 reagent (1 vial each) and CliniMACS PBS/EDTA buffer were obtained from Miltenyi Biotec (Bergisch-Gladbach, Germany). The CliniMACS Plus Instrument (Miltenyi Biotec) utilizes immunomagnetic techniques to isolate hematopoietic progenitor cells (HPCs), T cells, NK cells, and monocytes. However, development of protocols that provide large numbers of functional NK cells produced under GMP conditions are required to facilitate clinical studies. 4.42). ®CliniMACS Plus Protocol Processing time about 4.5h. 5 L waste bag. Process for enrichment of IFN-γ. Natural killer (NK) cell-based adoptive immunotherapy is a promising treatment approach for many cancers. The CliniMACS system is a fully automated device designated for cell processing ... the Sepax 2 RM instrument, by performing a manual hard spin via centrifugation, ... Sorvall RC 3C Plus Centrifuge — 1200 rpm Allegra 6KR Centrifuge — 1249 rpm ? The collected cell fraction was bead depleted on the CliniMACS® … 60 cm for bag hangers) Weight approx. White, gray and black bars: column height depicts time, shading marks manual, automatic-supervised and autonomous preparation steps, respectively. https://www.frontiersin.org/articles/10.3389/fimmu.2019.02361 Subject matter expert on lentiviral and retroviral transduction of CD34+ cells and T cells, manual ficoll, tumor digestion and cryopreservation Manufactured … The CliniMACS Prodigy® represents the next generation in automated cell processing. To this end, on the day of harvest, 50% of the CliniMACS Prodigy® culture volume was drawn into a cell bag as part of the tubing set by a custom partial harvest process. The CD3‑ fraction was then incubated with CliniMACS CD56 MicroBeads (Miltenyi Biotec) in Sepax C‑Pro using the BeadWash C‑Pro protocol software (Table 1). CliniMACS Prodigy Tubing Set TS. Maintains a closed system. Peripheral blood apheresis products from 6 healthy donors (D1–D6) were obtained either from the Institute for Transfusion Medicine, Hannover Medical School (D1–D5), or from the Institute for Clinical Transfusion Medicine and Immunogenetics Ulm (D6) after the donors gave their … The T cell and B cell content per kg, from the Prodigy, was below 10x10^4/kg, the upper limit for clinical release criteria. Manufacturing of CAR T Cells Using the Automated CliniMACS Prodigy® Platform. 1/2011 CliniMACS® Products and applications • New MACS® GMP CD3 and CD28 antibodies • Cell Culture Bags Meeting minutes • Stem Cell Meeting Cologne 2010 • DC2010: Forum on Vaccine Science Customer reports • Generation of tumor-infiltrating lymphocyte cultures for adoptive therapy • … AccessGUDID - CliniMACS Plus Instrument (04049934004636)- The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS CD34 Reagent System. CD3, CD25, Cell separation steps done per CliniMACS® plus User Manual. Methods. CD34 + and CD45RA cells The CliniMACS is an automated cell-selection device, based on MACS technology. Tubing set, buffer, media . port to the CliniMACS LD Depletion Tubing Set (Miltenyi Biotec) and run on the CliniMACS Plus System using the Depletion Protocol 3.1 according to the manufacturer’s instructions. A total … Model CliniMACS Prodigy® Instrument (# 200-075-301) Dimensions Width: 73.5 cm (plus approx. — 333 Standardizing Standard Operating Procedures' (SOP) Manual The CliniMACS Plus semi-automatic instrument from Miltenyi Biotec has been used for decades for clinical-scale enrichment of CD34+ cells in a closed and sterile system.1 Miltenyi Biotec has recently developed a successor to the CliniMACS Plus, the CliniMACS Prodigy, which is a fully automated device with limited operator in- Cell sample, reagents, Programming (time of process end) Preparation . o APBMT-COMM-033 Records Management. the. 110-004-067. CliniMACS® Plus Process Safety Product – limit manual steps, connections and reconnections. The study will determine efficacy of this strategy in terms of engraftment, rates of acute and chronic Graft versus Host Disease (GvHD), and one year overall and event-free survival. CliniMACS Plus Instrument and Accessories. The manual preparation pro-cess for CliniMACS Plus selection involves repeated centrifugation, supernatant depletion, wash buf-fer addition, and cell resuspension steps, as well as many welding and sealing steps to connect and remove waste and buffer bags. CliniMACS® User Manual for the CD34 Reagent System clinical trial (see Clinical Performance below) using Collect the following data on the leukapheresis product for more information.) 9. Miltenyi Biotec GmbH. The CCS protocol on CliniMACS Prodigy is unrestrictedly functional. Article Snippet: Briefly, CliniMACS® Plus bead removal was performed using the CliniMACS® PBS/EDTA buffer (Miltenyi Biotec) supplemented with 0.5%HA (200 g/L, Baxter), the CliniMACS® Tubing Set LS (Miltenyi Biotec) and the software sequence Depletion 2.1. The automatic system is thus suitable for routine clinical application. 1.5 h . The remainder of the culture was bead depleted using the optimized process on the CliniMACS Prodigy ® system. CliniMACS® User Manual for the CD34 Reagent Worksheet CD45RA - 1 USER MANUAL - US Table of contents EDITION STEP 2 Start of the CliniMACS® plus Instrument and choice of separation program Download scientific diagram | CliniMACS ® Plus Instrument. Newsletter Vol. Figure Legend Snippet: Workflow of the automated T Cell Engineering (TCE) process and set up of the tubing sets at the CliniMACS Prodigy. At the start of the selection processes, apheresis products were 20–44 h old. 13. CliniMACS newsletter 2011 1. Process time is similar for both protocols, but hands-on time with Prodigy is much reduced. Download free of charge your instruction manual, user guide, owner's handbook, quick start guide, directions for use and repair book for mobile phones and smartphones, internet media tablets, digital cameras and film cameras, video game consoles, mp3 mp4 mp5 players, camcorders and movie cameras, action cams and dashcams, PDA, handheld computers and pocket PC, ebooks … The user-friendly key components of the CliniMACS® Plus Instrument offer sophisticated applications for a whole variety of separations. Split products could be .. The performance of the CliniMACS was evaluated with the comparison of the numbers of total nucleated cell (TNC) within and over the capacity of the normal scale column. munomagnetic beads. 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