At this year's ASGCT Conference, Solentim presented a platform combination of 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. Solentim 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, Solentim aims to ensure all 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
Dr. Ian Taylor, Chief Business Officer, Solentim Limited
Dr. Taylor has a Ph.D. in Biochemistry. He has more than 25 years of experience working in the conceptualization and commercialization of novel high-value life science instrumentation.
Prior to joining Solentim when it was founded ten years ago, Dr. Taylor was the Commercial Director at Genetix PLC, where he was responsible for the development and sales of the ClonePix FL for selection and isolation of high-value monoclonal-antibody-producing clones. Prior to that, Dr. Taylor was part of the senior leadership team for PerkinElmer Life Sciences.
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