Cell Therapy & Gene Therapy Equipment worked example

Cell Therapy Batch Failure Cost at 9.2% expected batch failure rate: a worked example

Push expected batch failure rate up to 9.2% and the picture changes. This example computes every intermediate figure at that operating point. a quality or operations team is estimating the cost impact of expected batch failures in a GMP production plan

The inputs for this scenario

  • Planned GMP batches at risk: 24 batches (unchanged)
  • Direct cost per failed batch: 185,000 $ / batch (unchanged)
  • Expected batch failure rate: 9.2 % (raised for this scenario; the documented default is 8)
  • Fixed deviation or remediation cost: 45,000 $ (unchanged)

Working through the calculation

  • Applying the documented formula (Variable failed-batch loss = planned GMP batches × direct cost per failed batch × expected batch failure rate) to the inputs above produces each figure below.
  • At this operating point the engine returns 453,480 $ expected loss for expected batch failure cost, the number this scenario is built around.
  • At this operating point the engine returns 18,895 $ / planned batch for expected loss per planned batch.
  • At this operating point the engine returns 408,480 $ for variable failed-batch loss.
  • At this operating point the engine returns 45,000 $ for fixed deviation or remediation cost.

How this compares with the baseline

  • Against the tool's baseline example, where expected batch failure rate sits at 8% and the headline result is 400,200 $ expected loss, this scenario comes in 13.31% above the baseline at 453,480 $ expected loss.
  • It computes expected failure cost as planned batches times direct cost per failed batch times failure rate, plus a fixed deviation or remediation cost. The value of this scenario is the size of the gap it exposes: that gap, priced out over a year, is the budget you can justify spending to close it.

Results at a glance

  • Expected batch failure cost: 453,480 $ expected loss (headline result)
  • Expected loss per planned batch: 18,895 $ / planned batch
  • Variable failed-batch loss: 408,480 $
  • Fixed deviation or remediation cost: 45,000 $

Run it with your numbers

  • Every input above is editable in the live Cell Therapy Batch Failure Cost calculator, which recalculates instantly and can be shared with the inputs intact.

Last reviewed 2026-05-12.