Cell Therapy Translation
Building on progress in translation of hESC derivation procedures as well as for cell therapies we have used our experience to establish the methodology and resources to translate any research programme for a new cell therapy into a GMP-compliant process (i.e. capable of producing cells for human application).
One of Roslin Cells key objectives is to partner with others to provide services for the translation of cell therapies from their research stages into processes which are ultimately suitable for clinical application. We work with large scale GMP manufacturers to ensure our translational outputs provide an easily transferable solution for manufacture for large scale clinical trials and commercial production.
Having translated several research protocols to GMP-compliant processes and having developed a methodology to streamline this process, Roslin Cells can ensure that its resources are used most efficiently to deliver results in as short a time as is possible.
Our translation programmes can provide:
- Access to GMP Grade pluripotent stem cells
- Baseline gap analysis of current product, process and technology
- Process development planning
- Manufacturing for pilot studies
- GMP manufacturing services
- Regulatory support and advice
- Commercial advice
- Access to a network of organisations developing or supporting the development of regenerative medicine cell therapies