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CE Pharm 2015 troubleshooting workshop report
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In late 2015, the CE Pharm conference, organized by CASSS, conducted its annual workshop on troubleshooting CE assays. The CE Pharm conference aims to bring together CE users from academia and industry, along with instrument vendors and regulatory agencies, in order to foster collaborative discussions and advance the application of CE. The troubleshooting workshop solicited real-life examples of difficult troubleshooting issues from the attendees. These were submitted anonymously prior to the start of the conference and presented by the organizers for discussion at the workshop. The intent was to allow attendees to identify whether other users were experiencing similar troubleshooting issues, as well as propose possible solutions which attendees could then test when they return to their labs. In order to focus the discussion, the workshop this year concentrated on troubleshooting issues related to capillary gel electrophoresis, or CE-SDS, a routine assay used in biopharmaceutical companies for purity analysis of drug substances. The discussion is summarized and compiled here in order to capture the points raised by the workshop attendees.

 

Troubleshooting CE-SDS: baseline disturbances, peak area repeatability and the presence of ghost peaks

CE Pharm 2015 troubleshooting workshop report

Workshop Leaders: Cari Sänger-van de Griend1, Timothy Blanc2
Scribes: Jiann Kae Luo3, Bernd Moritz4, Joop Waterval5, Fabian Suriano6
Compilers: Jiann Kae Luo, Cari Sänger-van de Griend

1. Kantisto BV, Baarn, the Netherlands; Uppsala University, Div. of Pharmaceutical Analytical Chemistry, Uppsala, Sweden; ACROSS, University of Tasmania, Hobart, Australia
2. Eli Lilly and Company, Branchburg, NY, USA
3. Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
4. F. Hoffmann-La Roche Ltd., Basel, Switzerland
5. Merck, Sharp & Dohme, Oss, The Netherlands
6. ANALIS s.a./n.v., Suralee, Belgium 

 

To download the full paper, click here.

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