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CliniMACS Prodigy®3
https://www.ancell-bio.com.tw/en/ Ancell Technology Inc.
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CliniMACS Prodigy®

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Automated cell manufacturing on a closed and scalable platform
The CliniMACS Prodigy® is an automated cell processing platform that enables scalable GMP-compliant manufacturing of cell therapy products, on a single device and within a single process setup.

With the perfect combination of CliniMACS Prodigy Instrument, CliniMACS Prodigy Tubing Sets, various accessories, as well as Reagents and Buffers, the CliniMACS Prodigy Platform provides advanced integrated solutions for streamlining cell processing workflows for a variety of cell types. With this flexible technology platform, fully automated cell processing for innovative and complex cell manufacturing protocols becomes a reality.

CliniMACS Prodigy®

The CliniMACS Prodigy represents the next generation in automated cell processing. This device offers advanced integrated solutions to streamline cell processing workflows – from cell separation through cell culture to formulation of the final product.

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. The cell processing unit for fully automated washing, fractionation and cultivation of cells represents an integral component of the device. These processing steps take place in a single-use chamber, which is included as part of specific CliniMACS Prodigy Tubing Sets. The magnetic cell separation unit comprises a second integral component, enabling the separation of virtually any cell type.

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Automation

Ensuring standardized GMP-compliant cell products over and over again

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Closed system

Reduced cleanroom requirements as well as increased product and operator safety

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Scalability

Reproducible processes across multiple instruments supporting centralized and decentralized manufacturing models

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Flexibility

Timely and safe cell manufacturing procedures with flexible protocol software for different cell types

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CliniMACS Prodigy® T Cell Transduction Process
Chimeric antigen receptor (CAR) T cell therapy is undoubtedly leading a revolution in cancer therapy. The recent successes of CAR T cell therapy in fighting hematologic malignancies have led to a tremendous increase of interest in the immunotherapeutic field. The great potential of genetically modified T cells now even expands into the area of solid tumors and infectious diseases. Currently, the manufacturing process of CAR T cells consists of various complex procedures, is labor intensive, and represents one of the biggest challenges in this area. The CliniMACS Prodigy TCT process provides a unique all-in-one solution to these challenges. With the CliniMACS Prodigy Platform, it is possible to generate gene-modified T cells via viral transduction and in a standardized and automated process. It is a breakthrough in cell manufacturing, and a leap to the next generation. Benefit from this widely used and well-established new technology, which is already being used in clinical settings.
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Clinical-scale expansion of transduced T cells is essential for a CAR T cell product. Optimal cultivation and expansion of transduced T cells rely on the strong synergy of MACS GMP T Cell TransAct, TexMACS™ GMP Medium, and MACS GMP Cytokines. CAR T cells can be expanded in TexMACS GMP Medium supplemented with IL-7 and IL-15 without the need for additional human
AB serum or animal derived components.

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CAR-T Relevant products:
Products Amount required 
CliniMACS Prodigy® 1 set 
CliniMACS Prodigy TS 520  1 set 
CliniMACS® PBS/EDTA Buffer  1 bag 
TexMACS™ GMP Medium   3×2 L bags
CliniMACS CD4 Reagent  1 vial
CliniMACS CD8 Reagent 1 vial 
MACS® GMP T Cell TransAct 1 vial
MACS GMP Recombinant Human IL-7  3 vials
MACS GMP Recombinant Human IL-15  3 vials
CliniMACS Prodigy® T Cell Transduction Process

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Dendritic cell (DC)-based vaccinations
Dendritic cell (DC)-based vaccinations in patients aim to modulate the immune response in order to enhance the immune system’s ability to attack tumor while sparing the host. In the last decade, a number of clinical studies using DCs for vaccination have been completed, largely with the easily accessible and well-characterized monocyte-derived DCs (Mo-DCs). Beneficial antitumor responses have been observed in some patients, illustrating the safety profile and clinical potential of this approach. With an increasing availability of anti-cancer drugs, the role of DC-based approaches in novel combination therapies has rapidly escalated. Today, the possibility of implementing new therapeutic protocols using primary dendritic cells grants exciting opportunities. Primary DC subsets have been reported to induce antigen-specific immune responses which correlated with clinical outcomes.
The preparation of cellular monocyte-derived dendritic cell (Mo-DC) products for clinical settings comprises several independent processing steps including density gradient centrifugation, monocyte separation, cell culture (differentiation and maturation), and possibly electroporation. To meet the increasing regulatory requirements for cell-based therapeutics, we have integrated all manufacturing steps in a closed system operated by an automated cell processing instrument, the CliniMACS Prodigy® with CliniMACS® Electroporator.

DC Relevant products:

Products for Mo-DC research Products for blood DC research
Product  Content Product Content
CliniMACS Prodigy Tubing Set TS510 1 set CliniMACS Prodigy Tubing Set TS310 1 set
CliniMACS Tubing Set TS 1 set CliniMACS Prodigy Tubing Set TS510  1 set
CliniMACS CD14 Reagent 1 set CliniMACS Tubing Set TS  1 set
DendriMACS GMP Medium  1 bag CliniMACS CD1c (BDCA-1) Biotin 1 vial
MACS GMP recombinant GM-CSF 1 vial CliniMACS CD304 (BDCA-4) Reagent 1 vial
MACS GMP recombinant Human IL-4 1 vial CliniMACS CD14 Reagent  1 vial
MACS GMP Human TNF-α 1 vial CliniMACS CD19 Reagent 1 vial
MACS GMP recombinant IL-1β  1 vial CliniMACS Anti-Biotin Reagent  1 vial
MACS GMP Recombinant Human IL-6  1 vial TexMACS GMP Medium  1 bag
MC CD14 monocyte control cocktail, human 1 vial MACS GMP recombinant GM-CSF 1 vial
Mo-DC Differentiation Inspector, human  1 vial MACS GMP recombinant Human IL-3 1 vial
MACS GMP recombinant Human IL-6 1 vial
MACS GMP CpG-P  1 vial
　 　 Blood Dendritic Cell Enumeration Kit, human 1 vial
 

CliniMACS® Electroporator

The CliniMACS Electroporator expands the possibilities of automated closed system cell processing. As a module of the CliniMACS Prodigy® Instrument it enables flexibility in large-scale transfection of various cell types.

The electroporation step is integrated into the automated cell manufacturing workflow of the CliniMACS Prodigy. After washing and rebuffering on the CliniMACS Prodigy, cells are transferred to the CliniMACS Electroporator. The cell suspension is divided into smaller samples and mixed with transfection material such as nucleic acids. Electroporation of the divided sample takes place in the electroporation cuvette, which is a component of the single-use CliniMACS Electroporation Tubing Set. After electroporation, cells are transferred back to the CliniMACS Prodigy for downstream cell processing.

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  • Standardized, automated process
    Ensuring GMP-compliant, standardized cell transfection as part of cell manufacturing performed by the CliniMACS Prodigy

  • Closed system
    Reduced cleanroom requirements as well as increased product and operator safety

  • Process optimization
    Electroporation parameters can be optimized cost-effectively in small-scale experiments

  • Flexibility
    Timely and safe transfection procedures with flexible electroporation parameters for different cell types

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Chimeric Antigen Receptor T cells

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