Working with a leading UK cell and gene therapy company on its flagship product
ReNeuron is a leading UK cell and gene therapy company with two products in clinical trials – ReN0001 for stroke, which is soon to enter Phase II clinical trials, and ReN009, soon to enter Phase I for limb ischaemia. The Cell and Gene Therapy Catapult worked with the company on making the manufacturing processes for the CTX stem cell line commercially ready, giving them access to our analytical, process development and manufacturing expertise.
Working in collaboration towards a solution
Combining ReNeuron’s product knowledge and our manufacturing expertise, the collaboration focused on scaling up manufacture of the cell line, automated manufacture and potency assays. Work on developing a cryogenically preserved product that can be stored for long periods of time – and to be used clinical trials – was also undertaken. Manufacturing skills at Roslin Cells in Edinburgh and the University of Loughborough also formed part of the collaboration.
The Cell and Gene Therapy Catapult expertise
This exciting project enabled us to put our novel process technology, assay and Quality by Design thinking to good use.
Following the initiation of the collaboration, ReNeuron received a £33m financing package from a group of funders and investors, including the Welsh Government, enabling it to position itself as a global leader in stem cell development. Commercial supplies of its products will be made at a new manufacturing factory in Wales.
Important support for the financing was provided by the validation of the Cell and Gene Therapy Catapult collaboration.
Generating health and wealth
The benefits of this collaboration included development of new expertise at the Cell and Gene Therapy Catapult which can be used again. In addition, it has helped a leading cell and gene therapy company cement its position in the UK, assisted in development of its new medicines, and enhanced its commercial and competitive edge.