Webinar: Charge Variant Analysis for High Throughput Process Development

Process development requires suitable analytical methods which are able to demonstrate process robustness for both upstream or downstream processes. The use of QbD and the increasing numbers of samples which require analysis has meant that we have had to employ new and higher throughput technologies in order to cope. One of the most troublesome assays to perform is charge variant analysis by CEX-HPLC which has been notoriously time consuming to perform and lacks the robustness required for high throughput applications. Utilizing the iCE3 with an Alcott autosampler we have been able to utilize the high throughput sampling of the device and be assured that the system delivers well controlled and reliable results. We will demonstrate comparability and robustness of the technique applied to analysis of process development samples.

Speakers

Dr. Simon Briggs, In-Process Analytics Team, UCB Pharma

Scott Mack, Senior Develpment Scientist, ProteinSimple