Most articles on advanced therapy supply chains are written for the sponsor. This one is written for the other side of the technical agreement: the contract packer, storage provider or distributor being asked to take on ATMP work, and the sponsor auditor who wants to know what good looks like.

Taking on cell therapy logistics is not a matter of adding a freezer and a new SOP. It changes the quality system, the facility layout, the training matrix, the deviation process and the record retention policy. Providers who treat it as an extension of standard pharmaceutical distribution tend to discover the gaps during a sponsor audit rather than during the design phase.

The sections below set out what has to be in place, in the order it usually needs to be built.

Define the product class properly first

Advanced therapy medicinal products comprise four categories, and the differences matter because they change which regulator and which controls apply.

• Gene therapy medicinal products, containing a recombinant nucleic acid used to regulate, repair, replace, add or delete a genetic sequence.
• Somatic cell therapy medicinal products, containing cells or tissues that have been substantially manipulated, or are used for a different essential function in the recipient than in the donor.
• Tissue-engineered products, containing engineered cells or tissues presented as having properties for regenerating, repairing or replacing human tissue.
• Combined ATMPs, which incorporate a medical device as an integral part of the product.

Combined ATMPs are the category most often underestimated by providers. A device component brings device requirements alongside medicinal product requirements, including quality management system expectations under ISO 13485 and, where a sterile barrier is involved, packaging integrity standards.

The regulatory frame you are operating inside

MHRA. ATMPs are regulated as medicinal products in the UK. Manufacture and packing up to QP certification sit under GMP and require a Manufacturer's or Importer's Authorisation. Storage and distribution of released product sit under GDP and require a Wholesale Dealer's Authorisation, with a named Responsible Person. A provider doing both needs both authorisations. The UK GDP framework derives from EU Guidelines 2013/C 343/01, retained in UK law.

Human Tissue Authority. Where human tissues and cells are procured, tested, processed or stored, the HTA has a role alongside the MHRA. Providers need to establish clearly, in writing, whether the activity they are performing falls inside HTA licensable scope or sits wholly within the medicines regime. Getting this boundary wrong is one of the more common findings in early ATMP audits.

GMP for ATMPs and the risk-based approach. ATMP manufacture is governed by ATMP-specific GMP guidance rather than by conventional GMP alone. It permits a risk-based approach: controls are justified against the specific risks of the product and process, rather than applied uniformly. For a logistics or packing provider this cuts both ways. It allows proportionate controls for lower-risk activities such as kitting of ancillary materials. It also means the provider has to document the risk rationale rather than point at a generic standard.

Import. Where product or starting material arrives from outside the UK, the site of importation carries the certification responsibility, and the QP at that site certifies the batch. This is why import status and QP capability are commercially significant in ATMP programmes.

Building the operational capability

Qualified storage in the right bands

Storage has to be qualified, mapped and continuously monitored in every band the provider offers, with calibrated sensors, alarm escalation to a named out-of-hours responder and documented seasonal remapping. ATMP programmes commonly span ambient, +2°C to +8°C, −20°C, −80°C ultra-low and cryogenic below −150°C. No single provider needs to hold all of them, but every provider needs to state precisely which bands it holds and which it coordinates through approved partners. Overstating the range is the fastest way to fail an audit.

Central Pharma's in-house range at Bedford is ambient, +2°C to +8°C refrigerated and −20°C freezer, within temperature-monitored and controlled warehousing under MIA and WDA(H).

Segregation and contamination control

Patient-specific material cannot be allowed to mix. That means physically segregated or dedicated areas, defined material flows, single-batch working where practical, and cleaning and line clearance procedures written around the risk of one patient's material contaminating another's. Where material may be from an untested or positive donor, additional containment and separate storage are required. Cross-contamination control in ATMP work is a patient safety control, not a housekeeping control.

Labelling, kitting and secondary packing

Practical ATMP work for a packing provider usually looks like this: labelling of vials, bags and cassettes; assembly of treatment kits containing the ancillary materials a treatment centre needs; secondary packing into qualified shippers; and preparation of documentation packs. Labels must carry the patient or donor identifiers that maintain chain of identity, print quality has to survive cryogenic conditions where relevant, and label reconciliation has to be exact because a spare label with a patient identifier on it is a serious deviation.

Deviations and excursions where rejection is not an option

Conventional deviation handling assumes that a non-conforming batch can be rejected. In autologous therapy there is nothing to replace it with. The process therefore has to support rapid assessment and a documented risk-benefit decision, involving the sponsor, the QP and often the treating clinician, within hours rather than days. Providers should establish in advance who is contactable, who decides, and what data the decision needs.

Traceability and record retention

ATMP traceability records linking donor, patient, starting material and finished product must be retained for long periods, considerably longer than standard batch records. Retention obligations of decades are typical in this field. Build the archive, and the retrieval process, on that assumption from day one, including how records survive a system migration.

People

Training has to cover the specific product class, aseptic and containment behaviours, identity verification procedures and the escalation route. Competence should be assessed, not just recorded as attendance.

Technical agreements decide who owns what

Every ATMP relationship needs a written technical or quality agreement that is specific rather than templated. It should state who qualifies the shipper, who owns the temperature data and who reviews it, who assesses an excursion and who takes the disposition decision, who holds traceability records and for how long, what the notification timescales are, and what happens out of hours and at weekends. Ambiguity here surfaces at the worst possible moment.

Key takeaways

• ATMPs cover gene therapy, somatic cell therapy, tissue-engineered and combined products, and the combined category pulls medical device requirements into scope.
• Cell therapy logistics providers may need MIA and WDA(H) authorisations, and must establish clearly where Human Tissue Authority scope begins and ends.
• The risk-based approach in ATMP GMP allows proportionate controls but requires the provider to document the rationale.
• Deviation processes must support rapid risk-benefit decisions, because an autologous batch cannot simply be rejected.
• Traceability records carry very long retention obligations, so archive design and retrieval need planning at the outset.

Talk to Central Pharma about ATMP and cell therapy logistics

Central Pharma provides GMP and GDP licensed support to cell and gene therapy programmes from Bedford under MHRA MIA and WDA(H), with FDA registration for secondary packing and labelling, ISO 9001 and ISO 13485 certification, kitting, labelling, secondary packing, temperature-monitored storage across ambient, +2°C to +8°C and −20°C, site of importation status, three Qualified Persons, QP release to more than 60 countries and dedicated project management. Deep-cryogenic steps are handled through specialist approved partners. Get in touch

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