Gaining control over purity and yield in biopharmaceutical production is becoming essential for regulatory approval of drugs. Organizations such as the FDA are calling for better process understanding. Systematic analysis is crucial for making improvements in upstream and downstream processes.
The 2-D DIGE method is a promising tool that enables the analysis of optimal growth conditions and purification methods. The use of an internal standard enables the linking of analyses of upstream and downstream changes. As 2-D DIGE runs an in-gel standard with each sample, comparisons among samples are precise, thereby providing reliable detection and quantitation of changes in impurities resulting from process manipulations. 2-D DIGE is an easily validated method for HCP determination that delivers high-quality results.