Empowering the NHS advanced therapies ordering prototype IT system with Manufacturing insight from an electronic batch manufacturing system

automomous是一家由高级治疗药物产品（ATMP）和软件开发专家共同创立的公司，他们将各自的技能结合起来，为ATMP供应链提供优雅的解决方案。该公司正在创建一个软件解决方案平台，以便安排患者在医院收集细胞的时间；将这些细胞运送到生产现场；对生产过程进行跟踪，以满足生产的监管义务；药品的合法放行；并按时将患者专用药物运送到医院，以满足患者正在进行的治疗。该软件将提高流程的自动化程度（由于这种治疗的时间敏感性，必须提高效率），减少错误的风险（right - first - time， RFT），并确保正确的产品返回给正确的患者（错误的产品流向错误的患者是灾难性的；在最好的情况下，药物将不起作用，在最坏的情况下，它将杀死患者）。atmp处于个体化药物的前沿，已经在多个医学领域的临床实践中推动了显著的变化，包括新的癌症疗法、再生治疗和增强伤口愈合。几乎所有的atmp都是由病人自己的细胞制成的，这就创造了一种针对他们特定疾病的真正个性化的药物。这使得生产和供应具有独特的挑战性，不像任何其他类型的药物，使得这些疗法非常昂贵。首个用于癌症治疗的ATMP是诺华公司（Novartis）生产的Kymriah，在英国每剂售价为27.5万英镑。最近一项针对血液疾病的基因疗法ATMP每次治疗花费100万美元。其中大部分是制造成本。普通药物不需要制药公司组织患者细胞的收集，转移到生产现场，一个复杂的生产过程，测试一批只治疗一个病人，然后精确定时地将治疗药物及时送回医院，按照他们现有的治疗途径治疗同一个病人。该项目旨在通过提高NHS ATMP订购系统（NHS- atop）的制造洞察力，加强/建立现有的ATTC基础设施，进一步提高调度的稳健性，最大限度地利用昂贵的GMP制造资源，并促进NHS ATMP流程中的right - first (RFT) ATMP制造。

Autolomous is a company founded by Advanced Therapy Medicinal Product (ATMP)- and software development experts, who have combined their skills to deliver elegant solutions to the ATMP supply-chain. The company is creating a platform of software solutions to enable the scheduling of the patient for collection of their cells in a hospital; the transport of those cells to the production site; the tracking of the manufacturing process to meet regulatory obligations of production; the legal release of the medicine; and the scheduled delivery of the patient-specific medicine to the hospital in time to meet the on-going treatment of the patient. The software will enable increased automation of the process (increase efficiency necessary due to the time sensitiveness of this type of treatment), reducing the risk of errors (Right-First-Time, RFT) and ensuring that the correct product is returned to the right patient (The wrong product going to the wrong patient is catastrophic; in the best case the medicine won't work, in the worst case it will kill the patient).ATMPs are at the frontline of personalised medicines and are already driving remarkable changes in clinical practice across multiple fields of medicine, including new cancer therapies, regenerative treatments, and enhanced wound healing. Nearly all ATMPs are made from a patient's own cells, creating a truly personalised medicine targeted at their specific disease. This makes the manufacture and supply uniquely challenging, unlike any other type of medicine, making these therapies very expensive. The first ATMP for cancer treatment was Kymriah, produced by Novartis, costing £275k per dose in the UK. One recent gene therapy ATMP for a blood disorder costs $1m per treatment. Most of this is the cost of manufacture.Ordinary drugs don't require the drug company to organise the collection of patient cells, transfer to the manufacturing site, a complex manufacturing process, testing of a batch which will only treat one patient, and then the precisely timed delivery of the therapy back to the hospital in time to treat the same patient in line with their existing treatment pathway.This project aims to enhance/build upon existing ATTC infrastructure through enhancement of the NHS ATMP ordering system (NHS-ATOP) with manufacturing insights, further increasing the robustness of the scheduling and maximising the utilisation of expensive GMP manufacturing resources and facilitate Right-First-Time (RFT) ATMP manufacturing within the NHS ATMP process.