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At this year’s ISSCR Conference, Advanced Instruments presented 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.
This talk includes the following:
Discuss the importance of the matrix, MatriClone
Illustrate the timeline improvements using the VIPS for single cell cloning iPSCs
Discuss cGMP requirements and considerations in choice of platform
Presentation of new data for gene-edited iPSCs