Cells for Therapeutic Applications
We isolate stem cells to the highest technical, ethical and regulatory standards that will facilitate progression through all stages of the development of a new cell based therapy. Our aim is to ensure that the cells are fit for purpose - ie they perform in a consistent way to achieve the desired therapeutic outcome with defined and understood risks.
In the development of a new cell therapy, a number of key issues must be addressed as the project proceeds:
- supply of consistent high quality cells that facilitate the demonstration that differentiation can be achieved in a consistent and stable manner to assure that cells used for clinical applications are of the same predictable quality
- establishment and validation of appropriate master and working cell banks
- understanding of characteristics of the cell line and their relevance to the intended therapeutic use (for example chronic vs acute administration)
- ensuring provision of traceability requirements for human and non-human sourced materials
We understand these issues and provide cells with supporting materials/programmes to ensure the development of therapeutic applications can progress rapidly and confidently.
