Assessment of Product Quality in Upstream Process Development Using Maurice™ CE-SDS and icIEF

Upstream processes in drug discovery and development require high throughput analytical tools that enable fast decision making. This whitepaper demonstrates the use of a single instrument, Maurice™, for the analysis of purity (CE-SDS) and charge heterogeneity (icIEF) of cell culture samples, both supernatants as well as purified antibodies. The study shows that: 

• Cell culture samples grown in five different flasks were analyzed with Turbo CE-SDS and icIEF
  • Each of the five flasks had a unique ratio of L-glutamine and GlutaMAX™, which are both used as supplements in cell culture media
  • Cell supernatants as well as Protein G-purified samples from each of the five flasks were analyzed
• For both types of samples, Turbo CE-SDS provided quantitative purity data and icIEF was able to detect and quantify small acidic and basic heterogeneity changes
• Turbo CE-SDS offers a fast analysis tool to screen a large number of upstream samples during the cell culture and cell line development stages
• icIEF is a useful tool not only to analyze purified and partially purified samples, but also crude upstream cell culture samples