Cutting edge technology
Transparency

With our extensive audit logging feature, you can have complete trust that everything that happens on the system is tracked & traceable, and every input and change in the manufacturing record is logged with the precise date and time as well as the identity of the recording user.

Data integrity

AutoloMATE® is designed to comply with guidance from UK MHRA, EU EMA & US FDA, going a step further through its use of ledger technology to ensure data immutability - records cannot be falsified and this can be demonstrated for every relevant item of data and transaction.

Control

AutoloMATE® provides a set of features to enhance Quality Assurance and Control such as special control tasks accessible only by qualified individuals and e-signing of the audit log review. Our software supports raising quality events, facilitating review and resolution.

Automation

By automating key parts of the manufacturing process such as running calculations, transcribing data from BMRs, forms & external systems like LIMS, AutoloMATE® speeds up processes, eliminates errors & improves communication of data between key departments.

How can AutoloMATE boost Advanced Therapy Manufacturing?

Autolomous provides manufacturers with ways to scale their operations, by deploying a fully integrated and digitised supply chain ecosystem.

Digitising workflows

AutoloMATE eBMR, which is commercially available, digitises batch manufacturing records, eliminating the need for vast amounts of paper. It has been designed to provide agility in a controlled environment, and can be configured for all different types of advanced therapy workflows, including Autologous - CAR-T, TIL, DC vaccine, and Allogeneic NK, IPSC, MSC. Using real-time data verification, AutoloMATE eBMR can accelerate the product review and release process reducing the total time required from up to 36 hours to as little as 2.

Smart scheduling

AutoloMATE CLOCK digitises all aspects of manufacturing scheduling to facilitate optimisation of manufacturing facility operations. By accounting for all critical data - such as clinicians schedule, equipment and clean room availability, courier interactions, CLOCK enables the scale-up and maximised utilisation of manufacturing resources while driving down cost-of-goods.

Streamlined release

AutoloMATE Assist supports the batch verification of advanced therapies. Data collated on the AutoloMATE® platform via AutoloMATE eBMR and AutoloMATE CLOCK will be assessed against specifications defined in the Critical Quality Attributes and visually presented to quality stakeholders (QC, QA, QP) enabling them to carry out assessments based on “review by exception” methodologies. Controlling and reducing manual data operations increases the integrity of the data, while reducing the risks associated, together driving efficiency, throughput and delivery of advanced therapies to patients.

Powerful integrations

AutoloMATE® comes with an always expanding set of integrations to external devices and systems, ranging from Laboratory Information Management Systems (LIMS) and Quality Management Systems (QMS) to cell counters and flow cytometers. These integrations allow us to get data from systems and devices and put them to use in the manufacturing record, speeding up processes, eliminating transcription errors, and simplifying the use of version controlled documents such as standard operating procedures.

Forward thinking…

We empower Advanced Therapy Manufacturers to gain new insights and efficiencies within their workflows

Request an info pack

To delve further into what we do at Autolomous, contact us to request an info pack or to get more details.