Cell & Gene Therapy Logistics: Building Reliable Cryogenic Corridors, End to End

Cell & Gene Therapy (CGT) programs depend on logistics that protect two things above all: time and identity. Apheresis material and finished doses must move in strict temperature bands, often in vapor phase liquid nitrogen (≈ −150 °C), with a chain of identity (CoI) and a chain of custody (CoC) documented at every handoff. BioMed Spedition designs and operates cryogenic corridors that meet these needs—without retrofitting general cold-chain processes.

What makes Cell & Gene Therapy logistics different?

• Personalized payloads: Each shipment is patient-specific; a mix-up is unacceptable.

• Cryogenic temperature: Dry shippers in vapor phase LN₂ demand validated conditioning and hold-time margins.

• Compressed timelines: Manufacturing and clinical schedules leave little buffer.

• Regulated handovers: GxP/GDP alignment, IATA-skilled handling, and customs preparedness reduce avoidable delays.

Our Cryo Corridor Method

1. Lane study & risk map. We map the full corridor—apheresis site → interim storage → manufacturing → return to infusion site—identifying exposure points (ramp waits, trans-shipment, customs). Each point has a defined control and escalation path.

2. Validated dry shippers. We select and condition shippers per specification, with pre-cool logs, weight checks, and hold-time validation that includes worst-case dwell assumptions. Breach indicators are fitted and documented.

3. Chain of identity & custody Patient identifiers are mirrored across labels, paperwork, and our digital tracker. A single-thread command minimizes handoffs. Every transfer is time-stamped, signed, and stored for audit.

4. Customs and compliance, done early. We prepare classification, permits, pre-clear documents, and destination specifics before pickup. The goal is simple: wheels-up with paperwork complete, not “document-chasing” at the last minute.

5. Decision-grade telemetry, Real-time temperature + GPS, gives us the signal to intervene. Alerts are routed to a named on-call team, with authority to execute the predefined exception playbook (reroute, swap shipper, secure cold storage, or coordinate uplift).

6. SLA with dependencies. We state the ETA range and hold-time, with the assumptions that make them true (uplift windows, site hours). This transparency lets clinical teams plan confidently.

Temperature bands we handle

• Cryogenic (vapor phase LN₂, ≈ −150 °C) for CGT materials and final doses.

• −20 °C and +2 to +8 °C for reagents or intermediate steps, using validated VIP + PCM pack-outs where needed.

Documentation you can audit

• Conditioning, pre-cool, and shipper inspection logs

• CoI/CoC forms with time-stamped handovers

• Telemetry trails and alert history

• Export/import paperwork and pre-clear records

• Deviation reports and corrective actions (when applicable)

Typical corridors we operate

• India ↔ EU / UK / US manufacturing lanes (export and re-import)

• In-country rush moves for clinical sites and specialty storage

• Hub-and-spoke designs for multi-site trials with standardized SOPs

Why BioMed Spedition

• Engineered, not improvised: Each corridor is designed from lane data, not promises.

• Single-thread custody: One command line; fewer chances for loss or delays.

• Measured controls: Validated dry shippers, documented conditioning, and hold-time math.

• Real-time control: Telemetry that triggers action, not just logging.

Start a corridor assessment

Share origin–destination, target hold time (h), and go-live window. We’ll return a concise plan: ETA range, shipper spec and conditioning steps, paperwork checklist, and the exception playbook we’ll run.

Learn more here!