Analytical Methods Qualification
Take advantage of developing the analytical methods early in your product development stage, understand the basic methodology and utilize our prior experience to guide your method qualification choice.
With you on your biologics journey...
Why analytical methods qualification?
Analytical methods qualification is also termed pre-validation and is the first documented measurement of the method’s performance under relevant guidelines and scientific purposes.
Generally, the parameters qualified include specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness, and system suitability.
3P’s analytical methods qualification services
We develop the analytical methods early in the product development stage; understanding the basic methodology and with our prior experience to guide which method qualification is needed. According to the agreed plan, we qualify the methods incorporating the specific parameters required and generate a qualification report for each analytical method. The results from the qualification are used later to develop the criteria for method validation, which will be required for progression into later-stage clinical trials.
What we will deliver
We deliver a fully defined standard operating procedure (SOP) for each method, including system suitability testing (SST) and assay acceptance criteria; Along with a methods qualification report containing detailed findings and justified conclusions.