The Cell and Gene Therapy Catapult is a UK based organisation established in 2012 as a centre of excellence in innovation. Their mission is to advance the growth of the cell and gene therapy industry in the UK, accelerating the translation of cell therapies towards commercialisation, by helping cell therapy organisations across the world translate early-stage research into commercially viable and investable therapies. The Cell and Gene Therapy Catapult selected eg technology to develop an automated injection device for intradermal delivery of a cell-based product for the treatment of Epidermolysis bullosa (EB), a chronic and debilitating skin condition.
The delivery device needed to be suitable for clinical use in trials, administering cells in reliable, repeatable and small volume injections over the treatment area. Existing available systems were either not practical, not clinically acceptable or resulted in excessive wastage of the product. For cell-based therapies, it is important that both delivery and uptake are optimised for efficacy.
eg technology’s project was to design and develop an initial prototype delivery system, followed by a fully CE marked product. In addition to the development of the device, we contributed extensively to the verification testing and compilation of the technical file.
Our electronics, software and mechanical engineering teams worked concurrently across a clearly defined phased development programme to meet the clinical and business goals of the Cell and Gene Therapy Catapult. We generated and agreed the specifications with the client and carried out user experience evaluations, conducted initial experiments and technical evaluation of a variety of delivery techniques before selecting the optimum approach for development. This was followed by the concept generation and preparation of testing schedules, before moving on to prototype development. This phase involved risk evaluation & reduction, generation of proof of principle models and test rigs, outline design, prototype generation, design verification and evaluation and the issue of relevant documentation. The final phase was clinical evaluation, in-vitro studies, design verification and CE marking.
Our engineers were successful in creating a high precision, repeatable dose delivery, hand-held, trigger-activated device and associated control box, with a sterile, single-use, disposable needle and tubing set. The device provides a high degree of precision in both delivery speed and depth, ensuring that the cell therapy product is delivered accurately to a pre-defined intradermal depth. Furthermore, the system that has been developed can potentially be used in a wider range of therapy treatments for intradermal and subcutaneous delivery. Studies have indicated that delivery speed, dose size and needle dwell time all have a significant impact on the quality of uptake within the skin. The device developed by eg technology allows medical professionals to control and adjust each of these parameters so that the device can be adapted to different treatments, allowing adjustment for administration on different parts of the body.