GEN Exclusives

More »

Tutorials

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

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Children and Antipsychotic Drugs

Do you think children and adolescents with behavioral problems are overmedicated?