Leading the Way in Life Science Technologies

GEN Exclusives

More »


More »
Jun 15, 2009 (Vol. 29, No. 12)

2-D DIGE Improves Process Understanding

New Methodology Can Be Used to Facilitate Host-Cell Protein Determination

  • Summary

    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. 

Related content

Be sure to take the GEN Poll

Drug Price Hikes

Novum Pharma recently raised the price of an acne cream by over 3,900% in less than a year-and-a-half and Mylan increased price of EpiPen from $100 to $608 . Do you think pharmaceutical companies need to be subjected to price controls?

More »