Innovative scalable technologies for production of cell therapies

The project aims to produce innovative modular technologies for the production of cell therapies with improved scalability, enhanced co, consistency, and efficacy, and the potential for reduced cost.
Categories
Cell and Gene therapies
Process control
Project status
100% Completed

Industry Need

Cell therapies, such as CAR-T cells, are increasingly important for the treatment of cancer and other maladies. Production of such therapies involves a series of time-intensive steps that have been translated from cell biology laboratory-based procedures. This proposal aims to produce innovative modular technologies for the production of cell therapies with improved scalability and enhanced consistency and efficacy.

Solution

The University of Delaware and team aim to develop innovative modular technologies to produce cell therapies with improved scalability, enhanced consistency and efficacy, and the potential for reduced cost. 


A prototype technology recently was established that integrates scalable, functionalized soft membranes into a flow-based device for enhancing T cell transduction and promoting T cell activation (completed PC3.1-132).  


This work (PC5.2T-108) will build from this successful prototype to address more processing steps and other cell therapies, facilitated by the growth of our academic-industrial partnerships.

Outputs/Deliverables

  • Deliverable: single device optimized for modular transduction demonstrating improved transduction over static conditions Device operating conditions have been demonstrated that give statistically similar or enhanced (up to 5-fold) transduction of primary T cells relative to static culture depending on the lentivirus used. Processing steps are now being combined (e.g., selection + transduction, activation + transduction), where transduction enhancement of primary T cells with CD19 has been demonstrated in the device with CD8 selection + CD19 transduction. 
  • Successful operating conditions have been identified for CD8+ or CD4+ Selection to produce an enriched population (>80% positive selection of target population).
  • Sequential process established with activation, transduction, and expansion for production of efficacious CAR T product.


Impacts

Establish workflows for enhancing the transduction of difficult-to-transduce cell types

Establish functionalities and workflows for cost-effective, short-term rapid T-cell processing steps.

Demonstrate devices for longer-term T-cell processing steps including closed-loop phenotype selection, activation, expansion, and transduction

Publications

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Project Lead

University of Delaware

University of Delaware

Participating Organizations

Agilent

Agilent

EMD Millipore Corporation

EMD Millipore Corporation