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

REX-001 疗法商业化生产的成本驱动流程重新设计、自动化和规模化

基本信息

批准号：
104197
负责人：
金额：
$ 163.44万
依托单位：
IXAKA LIMITED
依托单位国家：
英国
项目类别：
Collaborative R&D
财政年份：
2018
资助国家：
英国
起止时间：
2018 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=104197
关键词：
Cost driven process redesign automation

项目摘要

"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."

Rexgenero的领先项目（雷克斯-001）是一种创新的自体细胞疗法，处于严重肢体缺血的后期开发阶段，这是一种医疗需求高度未满足的主要疾病。雷克斯-001正处于临床开发的最后阶段，但要让许多需要它的患者获得这种潜在的新治疗方法，目前受到以稳健、成本效益高的方式生产和提供足够剂量的能力、运输物流和保质期的限制。Rexgenero、细胞和基因治疗弹射器（CGTC）、TrakCel和Fisher Bioservices（FBS）将开发雷克斯-001生产的商业规模生产工艺，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的后期临床细胞治疗生产从西班牙搬迁到英国位于Stevenage的CGTC Catapult制造中心，使Rexgenero在英国的生产基地成为未来欧洲市场的商业供应基地。建立商业上可行的雷克斯-001生产工艺将为英国带来重大的经济和健康效益，并为患者提供实质性的生活质量和健康效益。患有严重的肢体缺血"