Current initiatives in Process Analytical Technology (PAT) and Quality by Design (QbD) are driving the need to identify and thoroughly understand the relation between Critical Process Parameters (CPP) and Critical Quality
Attributes (CQAs)1. Design of Experiment (DOE) studies to test the effect of cell culture changes on post translational modifications of monoclonal antibodies (mAb) or to monitor the purification process, produces large number of samples that can greatly exceed the capacity of modern analytical laboratories. With increased samples comes the demand for a high throughput analytical platform with superior precision, automation, and ease of use.
Here we describe the use of the LabChip® microfluidics platform to analyze antibodies, demonstrating the assay’s precision in determining sample purity and quantification, its linear dynamic range, and capability to resolve low level impurities. The antibodies are analyzed under reducing and non-reducing conditions on a reusable microfluidic chip in an automated high-throughput mode with analysis time of 41 seconds per sample.