Download White Paper on Antibody Analysis
Date: 2.12.2013
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 its 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® GXII 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.
Download the whitepaper here to learn about:
• Design of Experiment (DOE) studies to test the effect of cell culture changes on post translational modifications of monoclonal antibodies (MAb) or to monitor its purification process, produces large number of samples that can greatly exceed the capacity of modern analytical laboratories.
• LabChip® GXII microfluidics can be used as a high throughput automated alternative to SDS-PAGE and conventional CE- SDS for screening antibody product quality attributes including quantification, fragmentation, and purity analysis. It offers a quick time to result (41 seconds per sample) with < 1% precision.
• The LabChip® GXII is now also being incorporated into formulation and QC departments (without the requirement for high throughput) within the biopharmaceutical industry, expanding on its traditional installation base within clone selection, cell line optimization and protein purification due to robust and sensitive protein assays.
