"Manufacture of cell and gene therapies (also known as Advanced Therapy Medicinal Products or ATMPs) is highly labour intensive and technically complex requiring a three-phase process: Primary Manufacturing (production), Secondary Manufacturing (storage, packing and distribution) and Final Preparation (delivery and patient administration), which due to the specialist requirements are currently undertaken by different organisations, using different processes, in separate and often geographically remote locations. The manual processes and multiple handling required to produce ATMPs results in low throughput and high costs. RFID technology is a well-established technology platform in high-volume sectors, such as the automotive industry and Fast Moving Consumer Goods, and is used to facilitate tracking and traceability of individual components, sub-systems and final product within and between sites. However, these systems cannot be simply transferred across to the ATMP industry due to the unique challenges associated with ATMP manufacture, including aspects of product viability, shelf life, batch sizes, cryogenic temperatures required for product storage and complex regulations to ensure patient safety. This project will develop and demonstrate a full-scale, regulatory compliant, cryogenic RFID system which works across the three stages of ATMP manufacture. The final system will de-risk and overcome a number of critical barriers to enable full and seamless adoption into the ATMP industry."

"ATMPs, which can be _cell or gene therapies_, show great potential in treating patients with conditions that cannot be cured with current treatments. These include arthritis, liver disease, several types of cancer, and diabetic ulcers. ATMPs are just beginning to be available, with the UK playing a leading role. However, even when new ATMP therapies are developed and shown to be effective, there are **major challenges in rolling them out to patients**. The reasons for this include: complexities in transporting a 'living' product, and lack of familiarity with such products in most NHS hospitals. The project lead is the Birmingham Biomedical Research Centre, a national centre of excellence. The Welsh government has also made a major investment in cell therapy and is supportive of NHS Wales as the joint-lead on this project. We are a **team of industrialists, clinicians, academics and computer system experts** who have all the necessary skills to succeed in this project. Our group **covers the Midlands and Wales** giving us access to major teaching hospitals and almost 15 million people providing a unique opportunity to set cell therapy up to succeed. We will: -Set up a network of hospitals with medical staff trained to receive and administer ATMPs. -Build seamless supply chains that ensure that 'living medicines' remain healthy and effective as they are moved from the production laboratory to the bedside. -Put in place the IT systems to manage the end-to-end process. -Validate this new infrastructure using real ATMPs -Deliver a programme that uses this infrastructure to speed up the testing of ATMPs in clinical trials. -Set-up protocols to test whether the **cost of a new ATMP is justified by its clinical effectiveness.** The benefits of MW-ATTC are (a) Patients with challenging illnesses will get access to breakthrough medicines; (b) ATMP companies will get access to the clinical mainstream and market; (c) Investment in this important industry sector will increase, as we demonstrate that the UK is an excellent location for ATMP R&D. MW-ATTC will be one of three Advanced Therapy Treatment Centres in the UK, working together for patients and ATMP innovators, to reinforce the UK's position as a world leader in this important field."

"The Northern Alliance Advanced Therapies Treatment Centre (NAATTC) is a group of NHS hospitals and services. NAATTC has a wide geographical reach across Scotland and the North of England and is responsible for the health care of 15 million NHS patients. Advanced therapies are becoming increasingly available with a growing number of companies developing them both in the UK and worldwide. They are based on the administration of gene- and cell-based products in specialities such as haematology, autoimmunity, hepatology, cardiology and ophthalmology. They are thought to be more effective than existing treatments and provide treatments for diseases where currently no effective therapy exists. However most are still in clinical trials. Advanced therapies present significant challenges to healthcare providers compared with existing treatments. Addressing these challenges in the NHS will require development and dissemination of new skills for nurses, doctors, hospital pharmacists, NHS managers, and commissioners such as NHS England and the clinical commissioning groups (CCGs). It will also require changes in the way treatment is delivered. The changes required in the NHS can only be properly implemented through partnership with the companies that are developing and providing advanced therapies to the NHS. Manufacturers will need assistance with clinical trials to ensure optimal trial design, effective recruitment into clinical trials, and long term follow up of outcomes. The manufacturing and distributing processes are complex and it is critical that these systems are integrated effectively with those within the NHS. The NAATTC already has considerable experience of delivering advanced therapies and clinical trials and will use this experience to work with manufacturers (and their supply chains) to significantly increase their capacity to deliver advanced therapies effectively, safely, and seamlessly to patients within the NHS. It will identify gaps in our existing provision and develop solutions to narrow and eliminate the gaps. It will share the best practice that it develops to other ATTCs and to other NHS organisations. The outcomes will be to deliver these promising therapies to NHS patients and to make the NHS a global leader in their delivery, creating health and wealth for the UK."

"Rexgenero's lead program (REX-001) is an innovative autologous cell therapy in late-stage development for critical limb ischaemia, a major disease with high unmet medical need. REX-001 is in the last phase of clinical development, but making this potential new treatment available to the many patients who need it is currently limited by the ability to manufacture and deliver sufficient doses in a robust, cost-effective manner, transportation logistics and shelf life. The proposed collaborative project between Rexgenero, the Cell and Gene Therapy Catapult (CGTC), TrakCel and Fisher Bioservices (FBS) will develop a commercial-scale manufacturing process for REX-001 production, with automated needle-to-needle supply chain management and extended shelf life, which is critical to increasing availability to the many patients who are likely to benefit and the usability at the hospital. The Project will enable relocation of Rexgenero's late stage clinical cell therapy manufacture from Spain to the UK's CGTC Catapult Manufacturing Centre in Stevenage, making the UK Rexgenero's manufacturing site for future commercial supply for European markets. Establishing a commercially-viable REX-001 manufacturing process will provide major economic and health benefits to the UK and provide substantial quality of life and health benefits to patients suffering with critical limb ischaemia."

Cell therapy manufacture is currently labour intensive, which presents a significant barrier to the growth of the industry. This project will introduce new manufacturing processes in to the industry which will drive down costs, improve quality and open up new markets. The project will develop and demonstrate key technology components required to automate the storage and retrieval of sample vials from multiple large capacity cryogenic storage devices (operating at temperatures down to -190oC) in such a way as to significantly increase retrieval throughput compared to current manual methods. The key outputs from the project will be: Design of a modular integrated architecture, and demonstration of the benefits in terms of throughput and asset utilisation, whilst also reducing the significant risks to the quality of product and operators using the current processes; Creation of modelling and simulation toolsets that enable new efficient manufacturing systems and infrastructure to be developed; The definition and specification of a “Next Generation” facility capabable of handling 100,000+ doses of critical cell therapy medicine per year.