Synthetic Biology Tech Transfer Readiness Score
Assess whether a synthetic biology process package is mature enough to hand off by scoring documentation, reproducibility, deviation management, and operator readiness.
Quality systems aide. Pair with full tech transfer risk assessments, validation protocols, and regulatory submissions.
Examples
- 92% documentation, 88% reproducibility, 80% deviation closure, 85% training ⇒ score 87.50 / 100, needs targeted remediation.
- 96% documentation, 93% reproducibility, 90% deviation closure, training blank ⇒ score 92.65 / 100, ready for GMP transfer.
FAQ
Can I adjust the weights for my organisation?
Yes. Export the underlying logic to a spreadsheet or clone the script, then update the weighting constants to reflect internal stage-gate criteria.
How do I measure reproducibility objectively?
Track the proportion of key performance indicators—titer, purity, productivity—within predefined bands across successive engineering runs. Use statistically valid sample sizes before scoring.
Should supplier readiness be included?
Supplier audits can be incorporated by adjusting the documentation component or adding a parallel readiness assessment for raw materials.
Additional Information
- Result unit: readiness score on a 0–100 scale.
- Weights emphasise reproducibility and documentation to mirror regulatory expectations for biologics transfer packages.
- Update the inputs after each engineering batch review or quality gate review.