A New Platform for Clinical Gene Editing of iPSCs to Make Clonal Cell Banks

A New Platform for Clinical Gene Editing of iPSCs to Make Clonal Cell Banks

Solentim presents 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 INDs.

Operational cGMP considerations will also be presented as we recognise the need for cell therapy customers to implement systems in research today that can then be replicated in their clinical manufacturing.  Solentim looks to bring its technology in-line with global cGMP requirements and validation according to cGMP and specific GAMP 5 principles plus regulatory requirements for computerised systems including 21 CFR part 11 and Eudralex Volume 4 annex 11. This is essential for customers planning to adopt this approach in their GMP manufacturing environment.

Illustrative data and images will be presented to demonstrate data quality, assurance and integrity and process improvements.

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.

 

 

Simon Hoffman, GMP Consultant

Simon is a Principal GMP Consultant with over 25 years’ experience in the pharmaceutical, medical device and healthcare industries. Having started his career in world-class companies such as Novartis and AstraZeneca, Simon has an extensive track record of designing and setting up large-scale manufacturing sites and laboratories and launching healthcare products globally, all in line with world-class standards, including FDA, MHRA and ISO standards. Simon’s most recent achievement was being a key adviser and hands-on key team member for the launch and scale up of a COVID-19 coronavirus vaccine in record time.