This is a ready-to-use worksheet for building and tracking the full collection-to-infusion time and temperature budget for an autologous or patient-specific cell therapy. It exists because each individual stage, collection, hold, transport, cryopreservation, manufacturing, release, return transport, thaw, infusion, is often qualified separately, while the question that actually determines whether a specific patient’s material stays viable is cumulative: does the sum of actual elapsed time at each stage still fit inside what the product’s own characterization data allows, end to end. Replace every <<FILL: ...>> placeholder with your own specifics. A worked specimen with invented numbers follows; the numbers illustrate the method only and are not a reported result from any real program.
Purpose
This worksheet maps every stage between <<FILL: apheresis collection>> and <<FILL: infusion or administration>> for <<FILL: product>> against its own qualified maximum duration and temperature range at that stage, and tracks actual elapsed time against that budget in real time for a given patient’s material, so a delay at one stage is visible against the remaining budget before the cumulative window is exceeded.
Scope
Applies to <<FILL: product / program>>, covering every stage from apheresis collection through final infusion, including any stage where the material is held, transported, cryopreserved, manufactured, tested, or thawed.
Responsibilities
| Role | Responsibility |
|---|---|
| Patient logistics or scheduling coordinator | Owns the live worksheet for a given patient’s material, updates actual elapsed time at each stage |
| Manufacturing science / process development | Establishes the qualified maximum duration and temperature range for each stage from real characterization data |
| Quality | Reviews and approves any stage where actual elapsed time approaches or exceeds its qualified maximum before the material proceeds |
| Clinical or collection site staff | Records actual timestamps at collection, courier handoff, and pre-infusion stages |
Stage budget table
| Stage | Qualified maximum duration | Qualified temperature range | Planned duration | Actual elapsed | Cumulative actual vs. cumulative budget | Owner |
|---|---|---|---|---|---|---|
| Apheresis collection | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Hold at collection site before transport | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Transport to cryopreservation or manufacturing site | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Cryopreservation (if applicable) | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Storage before manufacturing start | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Manufacturing | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| QC release testing | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Transport to clinical / infusion site | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Thaw and pre-infusion hold | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Infusion | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
Every stage’s actual elapsed time must fall within its own qualified maximum duration and temperature range. Where the process allows a stage to run over its planned duration but still inside its qualified maximum, the worksheet is updated and the material proceeds; where actual or projected elapsed time at any stage would exceed the qualified maximum, or the cumulative total across all stages to that point exceeds the cumulative budget the characterization data supports, the material is held and Quality makes the disposition decision before it proceeds, exactly as an out-of-range excursion would be handled under the cold chain program’s excursion investigation process.
How to use this worksheet for a live shipment
Populate the qualified maximum duration and temperature range columns once, from the product’s own characterization and shipping qualification data, and reuse that reference row set for every patient. For each real patient’s material, open a new instance of the table, fill in planned durations against the schedule, and update actual elapsed time and cumulative totals as each stage completes. A coordinator reviewing the worksheet mid-transit should be able to see, at a glance, how much of the total budget remains before a downstream stage even starts, not just whether the most recent stage individually passed.
Filled specimen
An invented illustration for ATX-207, an autologous CAR-T product; the numbers are for illustration only and are not a reported result from any real program.
| Stage | Qualified maximum | Planned | Actual | Cumulative actual vs. budget | Owner |
|---|---|---|---|---|---|
| Apheresis collection | Up to 4 hours procedure time | 3 hours | 3.1 hours | 3.1 / 4 hours | Collection site staff |
| Hold at collection site before transport | Up to 24 hours at 2 to 8 C | 4 hours | 5.5 hours | 8.6 / 28 hours | Patient logistics coordinator |
| Transport to manufacturing site | Up to 48 hours at 2 to 8 C | 18 hours | 20 hours | 28.6 / 76 hours | Courier / logistics coordinator |
| Storage before manufacturing start | Up to 24 hours at 2 to 8 C | 6 hours | 4 hours | 32.6 / 100 hours | Manufacturing intake |
| Manufacturing | Fixed process duration, 10 to 12 days | 11 days | 11.2 days | Within manufacturing window | Manufacturing |
| QC release testing | Up to 7 days | 5 days | 5 days | Within release window | QC |
| Transport to clinical site | Up to 24 hours, cryogenic per shipper qualification | 14 hours | 15 hours | Within shipping qualification | Logistics |
| Thaw and pre-infusion hold | Up to 3 hours at room temperature per thaw procedure | 1 hour | 1.5 hours | Within thaw window | Clinical site staff |
| Infusion | N/A | On schedule | On schedule | Complete, within total qualified vein-to-vein window | Clinical site staff |
The specimen shows the pattern the worksheet exists to catch: no single stage exceeded its own qualified maximum, but the transport and hold stages together consumed more of the early cumulative budget than planned, which the coordinator could see and account for against the later stages’ remaining margin, rather than discovering a tight margin only at the final infusion stage.
Common findings this worksheet prevents
- Each stage individually confirmed within its own qualified range, while nobody tracked the cumulative total against the product’s actual end-to-end viability window.
- A delay at an early stage, collection or transport, absorbed silently without checking whether it narrowed the margin available at a later stage.
- A fresh, unfrozen hold stage treated as having the same margin as a cryopreserved stage, when the two operate on entirely different time scales.
- No single, live document a coordinator, Quality, or an inspector can review to see the full collection-to-infusion picture for one specific patient’s material.
How to adapt this worksheet
- Populate the qualified maximum duration and temperature range for each stage from your own product’s characterization and shipping qualification data, not an industry figure.
- Add or remove stages to match your actual process; a program without a separate cryopreservation step, or with an additional intermediate transport leg, should reflect that in the stage list.
- Decide, before the first real patient shipment, who reviews the live worksheet and at what point a tightening cumulative margin triggers an escalation rather than being noticed only in retrospect.
- File the completed worksheet with the batch and shipment records for that patient’s material.