Cell & Gene Therapies
TIA brings together five key national cell and gene therapy development and manufacturing facilities (shown in the map below) to facilitate the translation from discovery to clinical benefit. Our consortium of CGT facilities has far reaching expertise to support and assist your development across the spectrum of cell and gene therapies regardless of your stage of development.
Cell, Tissue and Gene Therapies
Therapeutic paradigms including, but not limited to induced pluripotent stem cells, mesenchymal stromal cells, autologous and allogeneic CAR T-cells, gene therapies for rare diseases, tissue engineering and 3D bioprinting.
The highly personalised nature of many of the cell and gene therapies requires unique quality control tests for each therapy. The facilities can offer in process and for release quality control testing. They will be able to identify QC tests required and assist in work up of specific tests for your product.
We have developed two guidance documents to assist you in translating your research discovery into an advanced therapy medicinal product.
It is never too early to reach out to the facilities within TIA’s Cell & Gene Therapy Capability for advice on making the transition from research to development.
Early engagement with TIA or one of the facilities will enable you to leverage their significant expertise and expedite your translation to clinical development.
Understanding GMP requirements early will save you time and money.
Translation of your product out of the lab and into clinical development will require a shift of mindset from research curiosity to process reproducibility
You will need a robust, reproducible manufacturing method for tech transfer to a GMP grade facility
The quality, safety and efficacy of the product will be interrogated, defined and documented during translation and tech transfer