Cost-driven process redesign, automation and scale-out for commercial manufacture of REX-001 therapy

RexGenero的领先计划(REX-001)是一种针对严重肢体缺血的晚期开发的创新型自体细胞疗法，这是一种具有高度未得到满足的医疗需求的主要疾病。REX-001处于临床开发的最后阶段，但将这种潜在的新疗法提供给许多需要它的患者目前受到以强大、成本效益的方式制造和提供足够剂量的能力、运输物流和保质期的限制。RexGenero、细胞和基因治疗Catapult(CGTC)、TrakCel和Fisher Bioservices(FBS)拟议的合作项目将为REX-001的生产开发商业规模的制造流程，具有自动化的针对针供应链管理和延长的保质期，这对于增加许多可能受益的患者的可用性和医院的可用性至关重要。该项目将使RexGenero的晚期临床细胞疗法生产从西班牙迁至英国位于Stevenage的CGTC弹射器制造中心，使英国RexGenero成为未来向欧洲市场商业供应的制造基地。建立一个商业上可行的REX-001制造工艺将为英国带来重大的经济和健康好处，并为患有严重肢体缺血的患者提供大量的生活质量和健康益处。“

"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."