What happens
Physician prescribes the therapy. Coordinating nurse at the hospital calls in to place the order. Patient demographics, prescriber info, and scheduling details are captured.
Patient arrives at a certified apheresis center. Nurse draws blood, separates white blood cells. Collection kit is labeled with patient-specific identifiers.
Courier picks up the collection kit. Temperature-controlled shipping to the manufacturing facility. Chain of custody transfers at each handoff.
Manufacturing facility receives cells, confirms identity, begins engineering. Cells are modified, expanded, tested for quality, and packaged as a finished product.
Finished product is packaged in a cryogenic shipper. Courier picks up and transports back to the treatment site. Temperature and location tracked throughout.
Hospital receives the product, confirms patient identity match. Patient undergoes conditioning. Infusion administered. Outcome monitoring begins.
Who's involved
Prescribing physician, coordinating nurse, hospital call center, pharma commercial team
Apheresis nurse, patient, hospital scheduling, pharma commercial team
Courier service, pharma logistics, receiving dock at manufacturing site
Manufacturing team, quality assurance, pharma regulatory, batch release reviewers
Courier service, pharma logistics, hospital receiving
Treating physician, infusion nurse, patient, pharmacy, pharma medical affairs
Customer confidence
Cautious optimism. First interaction with new vendor. "Will this work for our workflow?"
High anxiety. Patient is physically present. Any error means starting over.
Blind spot. No direct visibility once it's in transit. "Where is it right now?"
Waiting. Longest phase. Customer checks in periodically. "Is it on schedule?"
Anticipation. Patient has been prepped. If shipping fails, the conditioning window may close.
Relief and focus. Product arrived, identity confirmed. Now it's clinical execution.
Pain points
Before the platform, orders were placed by phone and entered manually into spreadsheets. Transcription errors in patient names and addresses were common.
If the apheresis center isn't certified for this specific therapy, the collection can't happen. Certification status often wasn't tracked centrally.
Multiple courier handoffs with paper-based chain-of-custody forms. If a form was lost or mislabeled, the shipment could be rejected at receiving.
Batch failures happen. If a manufacturing run fails quality testing, the entire process restarts from collection. No system existed to coordinate the re-order automatically.
Patient conditioning (chemo) is timed to the product arrival. A shipping delay of even 24 hours can push the patient outside their treatment window.
Final identity verification was manual. The consequence of a mismatch (wrong patient gets wrong cells) is catastrophic and irreversible.
Decisions
Pharma decides whether to mandate the platform for all sites or allow sites to continue using phone/fax.
Does the platform verify site certification automatically, or does the coordinator check manually before scheduling?
Does the pharma company want real-time courier tracking integrated, or is email notification sufficient?
When a batch fails, who initiates the re-order? The manufacturing site, the pharma team, or the platform automatically?
How much lead time does the hospital need before the product ships? Too little and they can't prep. Too much and they're holding a bed.
Does the platform generate the final verification checklist, or does the hospital use their own?
Platform value
Digital order entry with validation rules. Patient identity verified at the point of entry. Scheduling conflicts flagged before they become problems.
Kit labeling generated from the order record, not hand-written. Scan-based verification at collection confirms the right kit matched to the right patient.
Digital chain of custody. Every handoff scanned and timestamped. Real-time alerts if temperature excursions occur or shipment is delayed.
Manufacturing status visible to the pharma team without phone calls. Automated notifications at key milestones.
Coordinated scheduling between manufacturing completion and hospital readiness. Platform calculates the window and alerts both sides if timing is at risk.
Final identity verification built into the workflow. Digital confirmation that the product matches the patient before the infusion team proceeds.