Digitising Cell & Gene Therapy Batch Verification: AUTOLOMATE-Assist

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.