Guide · Life Sciences
Cell therapy manufacturing software: a practical guide
By ATHIVEX · Updated
Cell therapies such as CAR-T are manufactured in small batches, often one batch for one patient. That changes what manufacturing software has to do. A mix-up between patients, a missing sample or a culture that will not reach its dose has consequences that are rare in other kinds of manufacturing, and the process has to be documented to GMP standards from start to finish.
This guide sets out what cell therapy manufacturing software needs to cover, how the common types of system differ, and the questions worth asking before you choose one.
What the software has to handle
Chain of identity and chain of custody
In autologous therapy the patient is both the source of the starting material and the recipient of the product. The software must carry one patient identifier through every step, sample, label and transfer, and check it at the points where a mix-up could happen: receipt, labelling, sampling, fill and shipment.
Electronic batch records
Each batch follows an approved master record. Operators record results as they work, the system checks values against limits, and every entry is attributable, time-stamped and kept in an audit trail. Paper and spreadsheets make this slow to review and easy to get wrong.
Label control
Bags, tubes and samples carry labels that must be printed from controlled data, applied to the right item and accounted for. Voided and reprinted labels need to be reconciled so the record shows what happened to every label.
Samples, QC and handover
In-process and release samples move from manufacturing to the QC laboratory. The software should record each draw, notify QC, link results back to the batch and compare them with the product specification.
Process monitoring
Cell expansion varies from patient to patient. Comparing daily counts and viability with the expected ranges for the product helps teams notice early when a culture may not reach its dose.
Review and release
QA needs a complete batch record that highlights exceptions, deviations and out-of-specification results, and lets an authorised person sign the review and release electronically.
eBR, MES, LIMS and orchestration: how they differ
| System | What it covers |
|---|---|
| eBR (electronic batch record) | Replaces the paper batch record: guided steps, data capture, limits, signatures and the record QA reviews. |
| MES (manufacturing execution system) | Runs execution on the shop floor more broadly: scheduling, equipment, materials and work orders. Many eBR products include MES functions, and the terms are often used together. |
| LIMS (laboratory information management system) | Manages the QC laboratory: samples, tests, results and specifications. Cell therapy sites usually need it to exchange data with the batch record. |
| Orchestration platform | Coordinates the patient journey across hospitals, couriers and manufacturing sites: scheduling the collection, tracking shipments and returning the product to the treatment centre. |
Most manufacturers need more than one of these. What matters is that patient identity, batch data and QC results are connected, so that nobody has to re-type an identifier from one system into another.
Questions to ask a vendor
- How is the patient's chain of identity checked at each step, and what happens when a scan does not match?
- Can our process, labels and specifications be configured without custom code, and how are changes controlled?
- How are labels printed, voided, reprinted and reconciled in the batch record?
- How do in-process results get compared with our product's expected ranges, and who is alerted?
- Which 21 CFR Part 11 and EU GMP Annex 11 controls does the software provide, and what validation support is offered for our installation?
- Can the system be hosted, installed on-premise, or both? Where is the data stored?
- How long does a pilot take, and what do we need to provide for it?
A note on compliance
Software can provide the controls that regulations such as 21 CFR Part 11 and EU GMP Annex 11 expect: unique user accounts, electronic signatures, audit trails and access control. It cannot make a process compliant on its own. Each installation is validated by the manufacturer for its intended use, so ask vendors what documentation and support they provide for that work.
From ATHIVEX
CellControl
CellControl is our electronic batch record software for cell therapy manufacturing, built first for autologous CAR-T. It guides operators step by step, carries the chain of identity through every task, sample and label, checks items when they are scanned, and forecasts whether a culture will reach its dose. We are accepting two pilot partners for 2027.