Key-person risk in cell & gene therapy

In autologous therapy every batch is made for one patient, and the schedule starts with the patient, not the plant. That makes dependency on people more expensive here than in almost any other part of pharma: a decision that waits for one person can delay a patient's treatment.

Where does dependency concentrate in CGT?

• Patient scheduling. One coordinator often agrees every manufacturing slot with the treatment centres by email and phone.
• Chain of identity. Transfers of patient material are noted on paper and entered into the record later.
• Deviations. Investigations of aseptic-process deviations wait for the one person trained to lead them.
• Batch records. Records come back from QA review with corrections, and an extra check is added on top of the required review.
• Qualification status. Supervisors check training, gowning and aseptic-simulation status by hand before each shift.

Which KPIs does the screening use for CGT?

• Deviation closure time: average calendar days from opening a deviation to QA approval of the closed investigation.
• Batch records returned: share of executed batch records sent back for at least one correction at first QA review.
• Chain-of-identity documentation lag: average hours between a physical transfer of patient material and its entry in the record.
• Manual cryo records: share of cryogenic storage and shipping units whose temperature record depends on a person reading and entering it.
• Patient scheduling lag: business days from the treatment centre confirming the patient is ready to written confirmation of the manufacturing slot.
• Qualification checks: minutes per qualified operator per month spent checking training, gowning and aseptic-simulation status by hand.

If you do not have a figure, the screening uses the industry median.

What does the audit look at in a CGT operation?

The workshop follows a patient's material from collection to infusion and asks, at each hand-off, who has to be present and what happens when they are not. Typical findings concern investigation know-how held by one person, scheduling that lives in one inbox, and identity records that lag behind the physical transfer. The sample report shows a fictional CGT company.

Start the free screening →