By Lun Xin, James Crichton, Spencer Beard, Wei Hong, Yao Chen, Todd Stone, and Yunsong, Catalent Biologics
Quality by Design (QbD) has been established as a guideline for pharmaceutical product development. The primary objective of analytical process development is to provide an optimized analytical method ready for method validation. This includes set points of operating parameters, ranges of these parameters, and system suitability targets (SST) criteria, Design of Experiment (DoE) is the centerpiece of analytical QbD. Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method attributes (e.g., range, accuracy, precision, ruggedness, and robustness) and key method attributes (e.g., data turnaround and assay transferability). It is common for contract manufacturing and development organizations to receive analytical methods at different stages of development. A different DoE approach can be used for assays that differ in level of readiness for our assay development pipeline (Figure 1). Here we present our DoE assay development pipeline. This pipeline approach delivers optimized, robust, and rugged analytical methods that are ready for method qualification.