Quality is a complex term that means different things to different people. Although one might struggle to define it precisely, every sponsor wants it and every CRO claims to have it.
At AIT Bioscience, when we talk about quality, it is a combination of data integrity, system integrity, and assay reliability and performance. Today’s discussion will focus on assay quality.
Our scientific founder and Executive Advisor, Ron Shoup Ph.D., is fond of reminding the method development scientists in the lab that “assays never perform better than they do in validation.” Although the act of validating a method strives to confirm method robustness that will withstand the rigors of pre-clinical or clinical sample analysis, there is just no way to cover every possible scenario, matrix or interferant that one might encounter.
Consider the effect of batch passing rate on method validation. If it takes, say 5 runs to achieve the 3 passing – core precision and accuracy runs needed to validate, then you can’t really say the method is performing better than a 60% passing rate. Likewise, a small molecule validation with %CV (Coefficients of Variance) in the ~ 13-14% range (+/-15% is FDA acceptance criteria), foretells a high probability of run failures during sample analysis.
AIT Bioscience is proud of our batch passing rates in validation:
- ADA validation- 88% batch passing rate
- LBA (PK and biomarker) validation- 91% batch passing rate
- Small molecule validation- 90% batch passing rate
What other CRO is giving you numbers like these paired with %CVs of single digits for small molecule and low teens for ligand binding assays (where the criteria are higher)?
Beyond the science in assay development, these methods need to be robust for long-term toxicology and clinical studies where the assay may be set up multiple times by different analysts over the course of several years. Batch failures and ISR failures due to poor assay performance can mean repeat analysis and can jeopardize the timely delivery of critical data.
Once in production, our assays have the passing numbers to substantiate the robustness we have built in:
- ADA Production – 96% batch passing rate
- LBA (PK and biomarker) Production – 82% batch passing rate
- Small Molecule Production – 95% batch passing rate
- And an overall 96% ISR passing rate
At AIT Bioscience our consistent and notably – high passing rates give our sponsors confidence that we can deliver quality data reliably and in reduced timeframes vs. our competitors. Perhaps this is why > 92% of 2017 survey respondents said they’d highly recommend AIT Bioscience to a colleague and why we have a >97% client retention rate.
How do we consistently deliver these results? Contact us to learn more!