Apheresis to Dose: De-risking the ATMP Supply Chain
Cell and gene therapies live or die on logistics. Time, temperature, and traceability must survive every handoff across sponsors, apheresis sites, CDMOs, depots, QPs, and clinics. This session focused on what operators can do now: assign ownership, design routes regulators accept, build release strategies that protect patients and schedules, and choose the right manufacturing model for speed and control.
19 Sep 2025
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Ashley Alderson
Captured live at Advanced Therapies Europe, this session turns real-world pain points into a practical playbook to move cell therapies on time and in spec.
TL;DR
In a hurry? Here are the essentials at a glance:
Put one accountable case owner on the entire chain with authority and 24/7 coverage.
Instrument every leg: GPS and temperature telemetry, clear chain of identity and custody.
Generate hold-time data and use rapid methods so fresh products can be released on time.
Involve a QP at design stage for EU and UK routes.
Frontload EU CTR requirements and define importer of record and depot strategy early.
Retire one-dollar customs valuations and align a defensible approach with finance and trade counsel.
Standardize SOPs and orchestration so sites do not juggle multiple platforms.
Choose centralized, decentralized, or hybrid based on shelf life, variability, and cost to control.
Supply chains work best when one person is clearly accountable. A named case manager coordinates sponsors, CROs, apheresis sites, CDMOs, QPs, and couriers, and triggers contingencies before a dose is at risk.
“These supply chains are inherently complex with so many stakeholders involved and they’re time-sensitive and very critical.” — Trisha Demko, Director, Case Management Services, Catalent
Make that ownership visible. Publish a RACI from collection to dose and rehearse it with a tabletop drill so roles hold under pressure. Pre-qualify vendors and set phase-appropriate quality agreements, so expectations match what the site and the QP will rely on when timelines tighten.
Design the route
A to B looks simple on a slide. In reality, every leg needs legal clearance, clinical oversight, and documents that match what you will release. Validate who touches the product and how they are controlled.
“I always ask a few questions when we get these approaches…” — Barry Oliver, Senior Principal, Quality & QP, Dark Horse Consulting
Make vendor management real: audit early, confirm qualifications, and name key professionals at the outset, including a Qualified Person and a medical doctor for apheresis sites. If collecting and transporting in the United States, confirm any interstate licensing. For EU activity, verify third-party MIA(IMP) and involve the QP at design stage. Align labels and forms with chain of identity and chain of custody.
Finish with borders. Name the importer of record, select the physical import site, and decide whether shipments enter the EU, the UK, or both. Plan separate documentation where needed: the UK accepts EU QP certification, while the EU does not accept UK certification.
Autologous vs allogeneic
Autologous is unforgiving on time. Build hold time for both incoming apheresis and outbound product so a delayed flight or late site does not collapse the schedule.
“We did… studies in order to extend… shelf life… that allow us to be… flexible in the starting of the manufacturing.” — Margherita Neri, GMP Manufacturing Senior Director, AGC Biologics
Allogeneic can batch and stock, but it adds depot qualification, QP release, and multi-country distribution with clear quarantine rules. Decide depot locations and documentation before the first lot moves.
“You do get to batch it all together. However, the complexity is still there… you have to have a depot.” — Benjamin Dewees, Senior Vice President, Regulatory Affairs, Artiva Biotherapeutics
Both models are complex, but autologous is generally more time-critical.
Release with speed and safety
Fresh products have narrow windows, so release design must move quickly while staying defensible. Build it as two phases: immediate, data-rich checks that support disposition in hours, followed by confirmatory sterility and extended assays in the weeks that follow. Bring the QP into that design early so the science, paperwork, and decision rights line up.
“We elaborated this double step of release from what you have available in few hours and what… will be available in the following weeks.” — Margherita Neri, AGC Biologics
Shipments under quarantine can be appropriate if criteria are explicit: which rapid results are required, who can release, and how to act if a later result fails. Document those rules in protocols and quality agreements, and close the loop by folding lessons learned back into batch records and periodic reviews of cycle time and right-first-time rates.
Navigate EU, UK, and customs
EU CTR is simpler after validation, but acceptance is frontloaded. Plan extra time to assemble regional documents before the application is even taken in, and reflect that in first-dose timelines.
“They won’t accept it until you’ve gotten all of your regional documentation in place.” — Benjamin Dewees, Artiva Biotherapeutics
Customs is shifting too. The long-used one-dollar valuation is being rejected more often, which creates uncertainty and can ripple into later pricing logic. Choose a defensible approach and keep trade and finance aligned.
“We’re getting push back on the one-dollar valuation of the product… they’re no longer permitting that as acceptable.” — Benjamin Dewees, Artiva Biotherapeutics
Keep the regulatory core consistent: maintain a unified IMPD with regional appendices, and document how the supply chain is controlled for regulatory purposes so reviewers see the same story you run operationally.
Involve QP early
QP insight belongs at the front of the program: vendor selection, IMPD planning, and route design. When a QP arrives late, teams end up revisiting audits, rewriting documents, and patching timelines.
“QPs tend to happen at the end… but actually they’re most valuable right at the front end.” — Barry Oliver, Dark Horse Consulting
A QP who understands cell and gene therapy can shape a release strategy that moves fast and holds up to scrutiny, including when shipment under quarantine is appropriate and what rapid results must support it.
“A QP… that can find a path to yes is a QP… to have on board, especially for cell and gene therapy.” — Barry Oliver, Dark Horse Consulting
Plan jurisdiction early as well. The UK accepts EU QP certification, while the EU does not accept UK certification, so build a separate UK path even when EU is cleared.
Standardize methods and orchestration
Clinics slow down when every sponsor turns up with a new portal and a different playbook. Aim for a single orchestration workflow that the site knows cold, supported by a 24/7 contact who can actually resolve issues. Standardize protocol, validation, and release templates so each handoff looks familiar to operators and the QP.
Logistics should be predictable, not heroic. Use premium couriers with active GPS and temperature telemetry, align labels with chain of identity and custody, and consolidate logins wherever possible. One workflow plus focused training beats three platforms and a stack of job aids every time.
Instrument identity and tracking
Make what matters visible. Location, temperature, identity, and custody should be observable in real time so the case manager and QP see the same data the courier sees, and decisions align with what is actually happening on the route.
“Having GPS-enabled tracking [and] temp monitors so that we understand where the product is every step of the way.” — Trisha Demko, Catalent
Treat alerts like part of the process, not an exception. Rehearse loss-of-signal and temperature-excursion scenarios, define who acts and how fast, and record responses in your deviation system. The result is fewer surprises and a tighter link between telemetry, documentation, and disposition.
Centralize, decentralize, or hybrid
Decentralization brings the dose closer to the bedside. It can cut weather and flight risk and help fresh product move on time, yet it multiplies comparability and oversight needs. Centralization simplifies control and analytics but depends on flawless lanes and contingency plans.
“[A] regional hub… near to the hospital or directly into the hospital… will… lead to more accessibility… but… will need a very strict… control in the quality management system.” — Margherita Neri, AGC Biologics
A hybrid model often lands best: centralize methods, analytics, and release authority, then place execution where it removes the most time. Use shared SOPs and reference assays to keep sites aligned, and keep data access uniform so the QP sees the same evidence regardless of where product is made. Measure what actually shortens time to dose and review it quarter by quarter.
Final word
Reduce uncertainty at every handoff: own the chain, generate data that buys time, standardize what repeats, and involve QPs early. Do this well and ATMPs move from fragile pilots to reliable patient access.
Keep the momentum: join the community at Advanced Therapies Week 2026 in San Diego, February 9 to 12, 2026.
The use of patient-specific starting materials, time-sensitive logistics, strict chain of identity and custody requirements, and highly regulated manufacturing processes contribute to the complexity.
QPs provide regulatory oversight, conduct vendor audits, approve product release, and help manage risk throughout manufacturing and distribution.
Differences in regional regulations, QP certification requirements, customs clearance, and compliance with clinical trial regulations complicate cross-border logistics.
Conducting hold-time studies to extend shelf life and having buffer periods in manufacturing schedules help accommodate logistical delays.
Decentralized manufacturing improves patient access and reduces transport time but requires stringent quality controls and regulatory harmonization across multiple sites.
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