RFID to enable ATMP Manufacturing, Cryogenic Supply Chain Scale-Up and Productivity Gains

细胞和基因疗法(也称为先进治疗药物产品或ATMP)的制造是高度劳动密集型和技术复杂的，需要三个阶段：一次制造(生产)、二次制造(储存、包装和分销)和最终准备(交付和患者管理)，由于专业要求，目前由不同的组织在不同的、通常是地理上偏远的地点使用不同的工艺进行。生产ATMP所需的人工过程和多次处理导致低产量和高成本。RFID技术是大批量行业(如汽车工业和快速消费品)的成熟技术平台，用于促进站点内和站点之间对单个零部件、子系统和最终产品的跟踪和可追溯性。然而，由于与ATMP制造相关的独特挑战，这些系统不能简单地转移到ATMP行业，包括产品生存能力、保质期、批次大小、产品储存所需的低温温度以及确保患者安全的复杂法规。该项目将开发和演示一种全面的、符合法规的低温RFID系统，该系统适用于ATMP制造的三个阶段。最终的系统将降低风险并克服一些关键障碍，以使ATMP行业能够全面和无缝地采用。“

"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."