Industries

Cell & Gene Therapy (ATMP)

In autologous cell and gene therapy every batch belongs to one patient. The systems that schedule collection, track chain of identity and custody, run manufacturing and support release are part of the therapy itself, where a mix-up is a patient-safety event rather than a deviation. We validate that estate end to end, sized to that risk.

Quick chat on WhatsAppHuman review at every gatePart 11 readyISO 9001 & 27001 certified

FDAEMAMHRAPMDACDSCOGAMP 5ICH Q921 CFR Part 11

In short

For cell and gene therapy, and autologous products above all, each batch belongs to one patient. The systems that schedule collection, track chain of identity and custody, run manufacturing and support release are therefore patient-safety systems. Validation focuses on identity and custody holding across every system boundary, and on keeping frequently updated orchestration platforms in a validated state.

Roadblocks

Identify The Roadblocks Slowing Your Growth

These challenges compound: cycles slow, scaling gets harder, and inspection posture drifts.

01Chain of identity across many systems

02Patient-specific batches on tight vein-to-vein timelines

03Orchestration platforms that change often

04ATMP GMP and Annex 1 expectations together

Regulations

Regulations We Cover

Every cell and gene therapy engagement is mapped to the regulations your inspectors will use.

Cell & gene
therapy

EU GMP Part IV (ATMPs)
EU GMP Annex 1 / Annex 11
FDA 21 CFR Part 1271 / 210 / 211
21 CFR Part 11

Where validation sits

01CollectionOrchestration platformSchedulingChain of identity from the first label
02LogisticsCourier trackingTemperature monitoringChain of custody and condition
03ManufacturingMES or paper batch recordsLIMSPatient-specific batch records
04Release testingLIMSeQMSRelease on reviewed, signed evidence
05InfusionOrchestration platformThe right product for the right patient

Where validated systems sit across a typical cell and gene therapy value chain, and what an inspector looks at in each stage. Typical systems shown; your estate will differ.

For cell and gene therapy

Services & Products For Cell & Gene Therapy (ATMP)

Services

Products

Chain of Identity Is a Requirement, Not a Feature

Chain of identity has to hold from the first label at the collection centre to the infusion, across scheduling, courier, manufacturing, testing and release. It rarely lives in one system. Each handoff, where an identifier is passed, scanned, printed or reconciled, is a place it can break, and each one should be a written requirement with its own test.

The failures worth testing are the realistic ones: a relabel after a deviation, a manual entry when a scanner is down, a rescheduled collection, two patients with similar identifiers on the same day. Validation that only proves the happy path does not prove the thing that matters.

Validating Orchestration and Scheduling Platforms

Most programmes run on an orchestration platform, often SaaS, that coordinates sites, slots, logistics and status. These platforms release frequently, which makes a traditional full re-validation per release impossible to sustain.

A risk-based approach works better: assess each release against the requirements it touches, rely on assessed supplier testing for standard functions, and focus your own testing on identity, custody and the integrations specific to your process. The validated state then keeps pace with the vendor instead of falling behind it.

Running a validated estate?Talk to a cell and gene therapy lead, or chat with us on WhatsApp.

ATMP GMP, Annex 1 and FDA Expectations

In the EU, ATMPs are made under the dedicated GMP guidelines in EudraLex Part IV, and aseptic processing is also shaped by the revised Annex 1 and its contamination control strategy. In the US, cell and tissue products fall under 21 CFR Part 1271 alongside the GMP and biologics regulations that apply to licensed products. Computerised systems in both regions are held to Part 11 and Annex 11 style expectations for records and signatures.

These frameworks agree on the essentials: know what each system does, control it, and be able to show its records are trustworthy. A single validation approach built on those essentials can satisfy both regions without running two programmes.

Release Under Time Pressure

Short shelf lives and patients waiting on treatment mean release decisions are made against the clock. That puts weight on the electronic batch record, on review by exception, and on Part 11 signatures that can be applied quickly without weakening what they attest to.

GxP Copilot keeps the evidence behind those systems current, and our validation leads design the review and signature workflow so speed and control do not trade against each other. When the batch is one patient, both have to hold.