Public Funding for Autolomous Ltd

In response to the Innovate UK (IUK) Digitalisation and Automation of Medicines R&D and Manufacture grant call, Autolomous and the Cell and Gene Therapy Catapult (CGTC) are proposing a collaboration that aims to enable key stakeholders in the CGT industry (namely therapy developers) to make meaningful progress towards improving manufacturing productivity and removing key bottlenecks through automation and digitisation. This will consequently reduce costs of CGT products and increase patient access to these life-changing therapies. Advanced Therapy Medicinal Products (ATMP), especially CGTs, are manufactured in per patient or in small batches requiring complex, semi-manual, labour intensive and time consuming manufacturing processes. A consequence of this is high drug product (DP) costs as demonstrated by currently available commercial CGT products ($400,000 to $3.5m per patient). Autolomous is the market leading developer of critical manufacturing management systems for CGTs. Autolomous internationally deploys fully integrated, digitized and automated supply chain software solutions. These solutions utilize emerging technologies such as Ledger Technology (LT) and Internet of Things (IoT) to ensure compliance with current and future regulatory requirements. CGTC is an independent innovation and technology organisation committed to the advancement of CGTs with a vision of a thriving industry delivering life changing advanced therapies to the world. The project aims to demonstrate the digital introduction of novel Process Analytical Technologies (PAT) into an industrial scale CGT manufacturing process within an industrial manufacturing facility. The project outputs will serve as blueprints outlining the key challenges and considerations of introducing new technologies into an industrial manufacturing environment, and the benefits of leveraging digitalisation for the purpose of automation of data collection to enable streamlined batch certification and release. The overall objective is to help ATMP developers and PAT providers mitigate the risk, reduce the costs and expedite the process of introducing and integrating systems and/or new technologies.

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.

Autolomous is a company founded by Advanced Therapy Medicinal Products (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 batch verification 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, minising any human error based on current manual paper based process) and ensuring that the correct product is returned to the right 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 manufacturing. Ordinary drugs don't require the drug company to organise the collection of patient cells, transfer to the manufacturing site, a complex manufacturing process, batch verification of each batch by a Qualified Person (QP) (the number of QPs are very limited and as such currently less than 20 in the UK) 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 digitise the batch verification process of Cell & Gene Therapies, current paper based, batch verification methods are labor intensive, time consuming and exposed to any human errors. Autolomous aim to digitise the process and unlock batch to batch insights, supporting continuous improvements.