Current cloning approaches include colony picking and two rounds of cloning, which is very time-consuming.
TORONTO (PRWEB) February 02, 2021
An emergent area of immuno-oncology and T-cell therapy is to make an “off-the-shelf” (or allogeneic) supply of suitably engineered T cells or natural killer (NK) cells so they can readily be administered across a wide variety of patients.
This supply can now be developed from suitable donor-patient induced pluripotent stem cells (iPSCs), and the first iPSC-derived CAR-T therapies are already enjoying success in the clinic.
However, somewhat analogous to monoclonal antibodies 20 years ago, the editing and single-cell cloning of stem cells has, up until now, largely been a black art reserved for experts. Current cloning approaches include colony picking and two rounds of cloning, which is very time-consuming.
Solentim now presents a platform combination of instrumentation and soluble matrix for the high-efficiency, high-viability single-cell cloning of iPSCs to form the Master Cell Bank. This includes an industry-leading clonality documentation package to support future investigational new drugs (INDs).
Illustrative data and images will be presented to demonstrate data quality assurance and integrity, process improvements, time and cost savings. Operational cGMP considerations will also be presented.
This platform will allow for groups to more easily perform clinical gene-editing and cloning of iPSCs across a broader range of cell therapies. It facilitates a more reproducible process for manufacturing cGMP Master Cell Banks of clonal iPSCs, the ability to standardize the process, help establish and meet the future regulatory expectations for clonality and make the number of gene-editing projects far more scalable.
Join Dr. Ian Taylor, Chief Business Officer, Solentim Limited; and Simon Hoffman, GMP Consultant in a live webinar on Thursday, February 25, 2021 at 11am EST (4pm GMT/UK) learn about a novel platform for easier clinical gene-editing and iPSC cloning.
For more information, or to register for this event, visit A New Platform for Clinical Gene- Editing of iPSCs to Make Clonal Cell Banks.
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