Creating a clinical grade iPS cell line to advance the cell and gene therapy industry.
It is more than a decade since 2006, when scientists reprogrammed mouse skin cells into cells that behave like and share similar characteristics with embryonic stem cells. This process was repeated using human cells a year later.
The resulting induced pluripotent stem cells (iPS cells) hold great promise in the field of regenerative medicine because of their ability to propagate and be converted to all of the body’s cell types. They have the potential to help treat diseases for which there is currently no cure or which have limited treatment options, such as blindness and Parkinson’s disease.
However, despite significant scientific advances in the intervening years there are still numerous barriers to be overcome before iPS cells move beyond the laboratory bench to be used for treating patients.
Developing an iPS cell line
In 2013, the Cell and Gene Therapy Catapult (CGT Catapult) funded a collaboration project with Roslin Cells, one of the leading developers of pluripotent stem cell, to overcome this barrier and to develop a suitable iPS cell line.
Projects such as this are established when there is a cross-industry problem that is unlikely to be solved by a company or researcher on their own. In this case there is a clear unmet need for a high quality clinical grade iPS cell line for use in both research and in the clinic for the benefit of patients.
In the project, cells from a female donor from New Zealand were reprogrammed using the episomal reprogramming method developed by Nobel-prize winning stem cell researcher Shinya Yamanaka and using GMP-grade vectors manufactured by NHSBT.
Once the reprogrammed cells were created, CGT Catapult and Roslin Cells created a clinical-grade pre-seed lot. From this pre-seed lot a research grade seed lot was developed and subsequently a master cell bank was manufactured followed by a working cell bank. The working cell bank has been fully characterised and the resulting research-grade cell line shown to be of excellent quality.
Future work
There are now plans in place to develop a fully GMP compliant clinical grade line. We have already agreed a collaboration with the Scottish National Blood Transfusion Service and Smart Cell Processing partners for them to have access to the iPS cell line to evaluate a SCP system that generates and expands iPS cells.
The SCP system was developed by Tokyo Electron Ltd (TEL), Shimadzu Corporation (SHIMADZU), Sinfonia Technology Co Ltd (SINFONIA) and Nikon Corporation (Nikon).
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