The second step in the supply chain case study series is registration and workflow management
TrakCel's case study showcases the journey of TCR Catapult's (a consortium of the Cell and Gene Therapy Catapult, UCL and Imperial College) gene-modified T-cell receptor therapy targeting WT1-overexpressing cells.
Several challenges needed to be addressed before starting phase I/II trials, including
- Process management
- Audit trail
During this project, TrakCel worked closely with CGTC’s manufacturing team at Guy’s Hospital, London. The project was focused on delivering auditable records for the manufacture of the WT1 product, see the full case study for details on the solutions and outcomes.