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New Platform for Clinical Gene-Editing of iPSCs to Make Clonal Cell Banks for the Manufacture of Allogeneic Cell Therapies

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.

Advanced Instruments now presents a platform combination of Solentim instrumentation (the VIPS™) and soluble matrix (MatriClone™, based on laminin) 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).

Most current instrumentation for stem cell isolation and cloning is only suitable for use in a research environment. Advanced Instruments realizes the need for cell therapy customers to implement systems in research now which can then be replicated and used in their clinical manufacturing. Therefore, Advanced Instruments aims to ensure all Solentim equipment is supplied in line with global cGMP requirements. That said, their equipment is fully validated according to cGMP and specific GAMP 5 principles and regulatory requirements for computerized systems, such as 21 CFR (Code of Federal Regulations) part 11 and EudraLex Volume 4, Annex 11. This is deemed as essential for customers planning to adopt this approach in their GMP manufacturing environment.