Accessing adult donor cells for Cell and Gene Therapy development
Several advanced cellular therapy products have received approval and are now commercially available, leading the way in a field poised to erupt. However, there are several big challenges to overcome if the they are to have a significant impact on patients’ lives on a mass scale. One of which is providing consistency and reliability. The goal is to provide a well-defined and tested product with guaranteed outcomes. This is very difficult for cell therapies because of the complexity of cells and their functional characteristics. Understanding and controlling the variability within the cell system will be critical and the sooner this is achieved the faster the research and trial processes can begin.
As the cornerstone to the Cell and Gene therapy development is human cells, this invariably becomes the biggest source of variability entering the development. Whether developing an autologous treatment or an allogenic cell bank. The original starting material, the donor and the way the cells are collected and transported are all critical factors.
Anthony Nolan has been providing cells for therapy, through the facilitation of stem cell transplants for over 40 years. The vision was to establish a register of Human Leucocyte Antigen (HLA) typed individuals who would be willing to donate cells to anyone in need. The primary critical attribute associated to the donor is HLA type. As a result the fate of the graft, and its success, is weighted on donor selection.
More rigorous assessment of products are required in the Cell and Gene Therapy arena if better consistency us going to be achieved. Here we address the Anthony Nolan’s approach to ensuring the starting cell material is best characterized and meets specification to ensure therapeutic success. Learning from our registry and Cord Blood Banking experience in donor selection and testing to launch our Cell and Gene Therapy Service.