Background
A biotech company developing a biologic product needed a potency assay to measure the product’s biological activity for quality control and stability testing, but no published assay existed for this specific mechanism of action.
The Challenge
It was unclear whether an existing assay format could be adapted to reliably and reproducibly measure this product’s specific activity, or whether an entirely new assay system would need to be developed.
Technological Uncertainty
It was not known in advance whether a cell-based or biochemical assay could produce a reliable, reproducible signal correlating with the product’s biological activity, given the product’s novel mechanism.
Experimental Development
The team systematically tested multiple assay formats and cell systems, evaluating signal reproducibility, correlation with known activity controls, and assay robustness across repeated runs.
What Failed?
An initial cell-based assay produced a measurable signal but showed high run-to-run variability that made it unsuitable for quality control use, requiring investigation of alternative cell lines and assay conditions.
Technological Advancement
The team developed a validated potency assay with acceptable reproducibility and correlation to biological activity, generating new methodological knowledge not previously available for this product class.
Potentially Relevant SR&ED Activities
- Systematic testing of assay formats and cell systems
- Reproducibility and robustness testing across repeated assay runs
- Assay validation against biological activity reference standards
What Would Generally Not Qualify
Running the finalized, validated assay for routine quality control testing on subsequent product batches would not itself qualify as further eligible development.
Documentation
Assay development records, reproducibility data across runs, and validation study reports comparing candidate assay formats would support this claim.
