GMP pluripotent derivatives
Lead: Gothenburg University – Anders Lindahl
Involved partners: AstraZeneca, Vecura, Takara BIO, Karolinska Institutet
”Karolinska Institutet Human Embryonic Stem Cell Bank.”
The project aims to establish Swedish pluripotent cell lines that will exist as both research grade and GMP grade master cell banks. These resources will enable direct translation of research to clinical products. Both hESC and hiPSC lines will be established and genetic modification for differentiation and HLA matching will be investigated.
Examples of tasks and actions:
- GMP derivation of non-CJD hESC line and establishment of research and GMP masterbanks
- GMP derivation of hiPSC line and establishment of research and GMP masterbanks
- validation of robust differentiation potential of established lines
- establish GMP grade genomic modification techniques
- directed differentiation of pluripotents stem cells
- HLA analysis and modification of lines for broad immune compatibility
Interview with project leader
Hi Anders Lindahl
What is the need your project addresses?
While pluripotent stem cells offer great potential for cellular therapies, most currently available clinical lines contain genomic abnormalities that make them unsuitable for clinical use. Further, whether hESC or hiPSC the robust ability to differentiate these cells and immunocompatibility with patients are critical parameters for clinical cell therapy successes. Today the reproducibility of differentiation protocols varies between cell lines.
What is your approach to meet the need?
By harnessing the best available technologies we will derive clinically suitable, GMP grade lines that are genomically normal and demonstrate robust differentiation potential. These lines will be rigourously tested for differentiation potential and genetically modified under GMP conditions to drive differentiation of lineages of interest. Further, cutting edge HLA modification strategies will be performed under GMP conditions to establish a master cell bank with broad genomic compatibility.
How will this improve Sweden´s capabilities within ATMPs?
These resources will establish Sweden’s position as a leader in clinical pluripotent cell therapy technologies. We aim to differentiate clinical batches of differentiated cells within the project to be used in Swedish clinical trials.
For more information please contact Anders Lindahl