Quality management and standards alignment

Establishes the quality management system expected of organisations designing medical devices and diagnostics. We are building document control, design history and change control practices against its structure so that any future device or diagnostic work starts inside a compliant framework rather than being retrofitted.

• Controlled, versioned protocols with named authors and review dates
• Design and development records kept from the first construct onward
• Documented change control for assay and protocol revisions
• Supplier and reagent qualification records

Risk management is the discipline most relevant to cell therapy at our stage. We use its framework to identify hazards, estimate and evaluate risk, and record mitigations across every workstream of the CAR-T programme.

• A living hazard register for each research programme
• Risk analysis recorded before, not after, experimental design
• Explicit residual-risk statements attached to programme milestones
• Safety findings fed back into construct and protocol design

GLP principles govern how non-clinical safety studies are planned, performed, recorded and reported. We apply them to our preclinical work so that data generated now can support regulatory conversations later.

• Study plans agreed and dated before work begins
• Raw data retained alongside processed results
• Equipment calibration and maintenance logs
• Independent internal review of reported results

We do not run clinical trials and have no clinical sites. GCP becomes operative only if and when a programme reaches human study. We name it here because our clinical investigator advisory conversations are structured with GCP expectations in mind, so a future transition is not a standing start.

• Endpoint definitions reviewed with clinical investigators
• Protocol drafting conventions aligned to ICH E6 structure
• No human subjects, no patient data, no recruitment activity today

Sample provenance decides whether a result can be trusted or reproduced. We follow biobanking requirements for collection, traceability, storage conditions and chain of custody for all donor-derived material.

• Unique identifiers and full chain-of-custody records per sample
• Monitored storage with temperature excursion logging
• Documented consent provenance for all donor-derived material
• Defined criteria for sample acceptance and disposal