Software Series · Cell Full Lifecycle Management Platform
Donor to patient,and patient back to donor.
A cell therapy is traceable or it is not approvable. The platform records the whole lifecycle, from the consent form at collection to the follow-up after treatment, on a data model CellAuto owns, and it runs on the same line as the equipment it controls.
Platform advantages
Full-scenario coverage
Research, production and clinical use, across biological products, radiopharmaceuticals and related fields, rather than one stage of the chain.
Flexible deployment
Independent modules, integrated system deployment, or software and hardware delivered together as one platform.
Customised one-stop service
Function configuration and process reconstruction to match how your business actually runs, not how a generic system assumes it runs.
Industrial digital upgrade
Full-lifecycle digital traceability for pharmaceutical products, which is what makes standardised and inspectable operation possible at industry scale.
Platform overview
Three things the platform doesthat a spreadsheet cannot.
The platform exists because cell manufacturing generates a record that has to survive inspection years later, and because the people who need that record are not in the same room as the machine.
Manufacturing
Automated, intelligent, digital and compliant management across the pharmaceutical lifecycle, covering product research and development, process development and optimisation, planning and scheduling, manufacturing operations, warehousing, quality management and equipment maintenance.
Traceability
A proprietary cell traceability architecture and full-lifecycle data model give complete traceability from donor to patient, and in reverse from patient back to donor, which is the requirement a cell product cannot be approved without.
Artificial intelligence
AI optimises process design and manufacturing control, and supports equipment monitoring, predictive maintenance and real-time trend analysis, so process improvement is continuous rather than retrospective.
Designed against published guidance: the MIIT Guidelines for Typical Intelligent Manufacturing Scenarios of Pharmaceutical Enterprises (2022), the NMPA GMP Guidelines for Cell Therapy Products (Trial), and the FDA discussion paper on Artificial Intelligence in Drug Manufacturing.
Application scenarios
Sample collection
Electronic informed consent, donor registration, unique sample identification and coding, full sample information recording and standardised collection documentation.
Transportation
Transport planning, automatic shipment records, real-time tracking, continuous monitoring of conditions inside the container, and automatic receipt confirmation and archiving. The same applies on the return leg to the clinic.
Manufacturing
Standardised sample receipt verification, intelligent production scheduling, comprehensive electronic batch records, closed-loop quality management and standardised cryopreservation and inventory.
Clinical application
Patient health records, standardised treatment documentation, structured follow-up, adverse event monitoring, and automatic generation of the clinical application summary.
Core capabilities
Compliance references are the standards the platform is designed against. Validation for a specific product, site and jurisdiction is carried out as part of the project.
Five software series,one platform.
The modules
Five series,thirteen named systems.
The platform is not one monolithic application. Each series is a set of systems that can be deployed on its own or together, which is what makes it possible to start with the part of the process that hurts most.
Module names are CellAuto’s own. Which of them a project needs depends on the process, the facility and the regulatory route, and is agreed during planning.
See it runningagainst your own process.
The platform is configured to the workflow you already have rather than the other way round. Tell us the process and we will show you what the record looks like at the end of it.