Cell Therapy & Gene Therapy Equipment worked example

Cell Therapy Batch Failure Cost at 5.76% expected batch failure rate: a worked example

Here is what the math looks like when conditions slip. We hold every other input steady and drop expected batch failure rate to 5.76%, then walk the calculation through step by step. Estimate expected financial exposure from failed, contaminated, or unreleased cell therapy and gene therapy batches.

The inputs for this scenario

  • Planned GMP batches at risk: 24 batches (held at the documented default)
  • Direct cost per failed batch: 185,000 $ / batch (held at the documented default)
  • Expected batch failure rate: 5.76 % (the input this scenario stresses; the baseline uses 8)
  • Fixed deviation or remediation cost: 45,000 $ (held at the documented default)

Working through the calculation

  • The calculation starts from the formula this tool documents: Variable failed-batch loss = planned GMP batches × direct cost per failed batch × expected batch failure rate.
  • Expected batch failure cost works out to 300,744 $ expected loss at these inputs, and this is the headline figure for the scenario.
  • Expected loss per planned batch works out to 12,531 $ / planned batch at these inputs.
  • Variable failed-batch loss works out to 255,744 $ at these inputs.
  • Fixed deviation or remediation cost works out to 45,000 $ at these inputs.

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 24.85% below the baseline at 300,744 $ expected loss.
  • The practical read: the gap between this scenario and the baseline is entirely attributable to expected batch failure rate, so recovering it is worth quantifying in dollars before considering equipment or staffing changes. It uses an average failure rate applied uniformly, so it does not capture clustered failures, learning curves on new processes, or the patient and reputational cost of a missed autologous dose.

Results at a glance

  • Expected batch failure cost: 300,744 $ expected loss (headline result)
  • Expected loss per planned batch: 12,531 $ / planned batch
  • Variable failed-batch loss: 255,744 $
  • Fixed deviation or remediation cost: 45,000 $

Run it with your numbers

  • To rerun this with your own numbers, open the live Cell Therapy Batch Failure Cost calculator, set expected batch failure rate to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.