Choosing a cell therapy logistics partner is not a procurement exercise with a quality annexe attached. The provider joins a chain where a single failure ends one patient's treatment, and where you remain accountable as contract giver regardless of who handled the material.

The questions below are organised by theme, each with what a good answer sounds like and what a weak one tells you. Pay as much attention to how an answer is given as to its content.

One point before the list. A provider candid about the boundary of their own capability, who names the subcontractors they use beyond it, is a lower risk than one who claims to do everything. Overclaiming does not disappear at contract signature. It reappears as a subcontractor you were never told about, holding your patient's material at 2am.

Licences and regulatory standing

Which authorisations do you hold, and what activities are on them? You want licence numbers and scope, not acronyms. MHRA WDA(H) for wholesale distribution, MIA where manufacturing or importation is involved, ISO 13485 where devices form part of a kit, and an HTA licence where human tissues and cells are procured, tested or stored. A good answer separates what sits on their own licence from what sits on someone else's.

When were you last inspected, and what were the findings? No provider has a clean history. A partner who describes a major finding, the CAPA and the closure evidence is showing you a functioning quality system. One who says inspections always go well will not tell you when something goes wrong.

Who is your Responsible Person, and can we meet them? The RP should be identifiable and able to describe their own stop authority without checking with colleagues.

Temperature capability and honesty about scope

What temperature ranges do you operate in house, and which are subcontracted? This is the most useful question in cell therapy logistics, because the answer separates genuine capability from brochure capability. Ask for evidenced ranges: ambient, +2°C to +8°C, −20°C, −80°C, cryogenic below −150°C. Then ask which they operate on their own site under their own licence.

A good answer is specific and unembarrassed. Central Pharma holds ambient, +2°C to +8°C refrigerated and −20°C frozen storage in temperature-monitored, GDP-compliant warehousing at Bedford, and uses specialist approved partners for deep-cryogenic steps. That is a line a sponsor can plan around.

A weak answer is a capability grid with every box ticked and nothing behind it. Follow up with: show me the summer and winter mapping report, the calibration records and the last requalification. If they exist, they appear quickly.

Chain of identity and chain of custody

What system do you use, and how does it integrate with ours? Most sponsors run a COI and COC platform. The practical question is whether the provider can receive and return data in your format, or whether their staff will rekey identifiers into a second system. Manual transcription between systems is a real identity risk.

Where do you scan, and what happens when a scan does not match? You want scanning at every handoff, an automatic stop on mismatch rather than a note for review, two-person verification at critical steps, and a validated paper fallback staff are trained to use. On patient data, expect pseudonymised identifiers only, the key held by the sponsor or treatment centre.

Scheduling and orchestration

Can you work backwards from a treatment date? ATMP supply is patient-scheduled, not stock-driven. A partner used to next-day fulfilment against a stock file may lack the planning process for a delivery window fixed by a hospital slot and a lymphodepletion schedule.

What happens when a manufacturing slot moves? Expect a named coordinator, a documented rescheduling process and clarity on how far downstream a change can be absorbed. Dedicated project management matters more here than any single piece of equipment.

Qualification of shippers, lanes and couriers

How are shipping systems qualified? Ask for hold-time qualification under realistic ambient profiles rather than the manufacturer's data sheet, plus a defined process for pre-conditioning, charging and inspecting units before dispatch.

How are lanes qualified? Route-specific transit time, customs dwell, contingency airports or depots, and evidence from real shipments rather than a model. For couriers, expect an approved vendor list with audit dates, competence requirements for hand-carry staff, and clarity on whether they subcontract.

Monitoring, telemetry and data access

What monitoring travels with the unit, and can we see it live? Real-time visibility matters most in the hours when intervention is still possible. Ask about logger type, data resolution, alarm thresholds, and whether you get read access or a report after the event. Establish too who owns the data and who holds the records if the contract ends.

Excursions, deviations and the 2am decision

Who makes the call at 2am, and what authority do they have? This reveals more than any other question. Look for a named on-call role, a defined escalation route to the sponsor and the QP, a notification target measured in hours, and rules on who may authorise a diversion, a re-icing or a hold. Fix the notification window in the technical agreement: learning about an excursion in a weekly report is not acceptable for a patient-specific unit.

Show me a recent deviation and its investigation. A redacted example shows whether investigations reach root cause or stop at operator error.

Contingency and business continuity

What happens if a freezer fails, a site is inaccessible or an aircraft is grounded? Expect backup storage capacity, tested standby power, alternative routing and a continuity plan that has been exercised. Ask when it was last tested and what it found.

Cross-border, import and export

Can you act as importer, and do you hold site of importation status? For product entering the UK, importation and QP certification arrangements determine whether the material can be released at all. Central Pharma is a site of importation and of QP release, with three Qualified Persons and product QP released to more than 60 countries. Ask too about pre-clearance and what happens when a consignment is held at the border.

Capacity, contracts and audit

Can you scale from clinical to commercial? Ask what changes between a handful of patients a month and a routine commercial programme: staffing, storage, systems, and whether one site handles both.

What will the technical agreement cover? Scope, authorisations held by each party, storage and transport conditions, excursion notification timescales, disposition authority, identity verification duties, subcontracting controls, data ownership, record retention and stock transfer on termination.

What audit rights do we have? Annual audit as standard, for-cause audit on demand, access to subcontractor sites, and a provider who treats audit as routine.

Key takeaways

• A partner who names the limits of their in-house capability and their subcontractors is a lower risk than one who claims everything.
• Ask which temperature ranges are physically operated on the provider's own site under their own licence, then ask for the mapping report.
• Chain of identity questions should cover system integration, scan enforcement at handoffs and the validated paper fallback.
• The 2am question, who decides on an excursion and how fast you are told, exposes the real operating model.
• Technical agreement scope and audit rights, including subcontractor access, are where accountability is fixed or lost.

Talk to Central Pharma about cell therapy logistics support

Put the questions in this article to us. Central Pharma, established in 2006 in Bedford, holds MHRA MIA and WDA(H), ISO 9001 and ISO 13485, with three Qualified Persons, site of importation and QP release status, and product QP released to more than 60 countries. Our capability covers temperature-monitored ambient, +2°C to +8°C and −20°C storage, Schedule 1 to 5 controlled drugs, labelling of sterile-filled vials and ampoules, kitting, inspection, pick and pack, regulatory support and dedicated project management. We will answer with licence scope, mapping reports, inspection history and named subcontractors rather than a capability grid. Let's talk.

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