As outlined in ICH Q2 (R2), the assay parameters that must be considered in a validation exercise are:
Specificity
Linearity
Range
Accuracy
Precision
Repeatability
Intermediate precision
Detection limit
Quantification limit
The requirements to confirm a successful validation are method-specific and a protocol will be designed based on risk management principles. While the number of assays can vary, they effectively assess a combination of the above parameters.
Labcorp’s biopharmaceutical CMC services can perform technical transfers as well as method robustness studies. We will structure these activities according to the needs of our clients and the availability of validated methods.
Where a validated method exists, Labcorp can perform a traditional technical transfer. Post initial gap assessment, feasibility and establishment testing, data equivalence will be confirmed between current and future laboratories
When no validated method exists or a data equivalence study is not feasible, Labcorp can perform a cross-validation study. Data equivalence between future laboratory and pre-established validation data will be confirmed
A comprehensive re-validation study may be required when significant changes are required within an analytical method. Labcorp has extensive experience in providing guidance and recommendations on the need for re-validation to meet regulatory requirements
We provide guidance on a selection of modality and method-specific parameters within pre-validation activities to help clients navigate the complexities of robustness testing requirements and limit initial costs
We provide subsequent testing that is performed later in the drug development life cycle and can be systematically expanded closer to, or in parallel with, follow-on actives to generate a final comprehensive data package
We can provide guidance following ICH Q14 AQbD principles to de-risk analytical control strategies
