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Invalid Rates Workshop: CE-SDS
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In late 2015, CASSS took the first steps to elevate and formalize the discussion on invalid rates. In response to growing interest at CASSS meetings for an objective measure of the invalid rates for analytical methods used by many pharmaceutical industries, we undertook a survey to understand how invalid rates are defined and tracked at different companies. Since invalid rates are likely defined differently for each analytical assay, we started with the example of 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.

 

Invalid rates workshop: CE-SDS

Workshop leaders: Sarah Kenneth1, Hermann Wätzig2, Cari Sänger-van de Griend3

Workshop design and data evaluation: Brian Nunnally4, Kai-Jorrit Maul2, Nadine M. Ritter5, Richard Rustandi6

Scribes: Joop Waterval7, Bernd Moritz8, Jiann Kae Luo9

1. FDA, CDER, Silver Spring, MD, USA
2. Technical University Braunschweig, Braunschweig, Germany
3. Kantisto BV, Baarn, the Netherlands;
Uppsala University, Div. of Pharmaceutical Analytical Chemistry, Uppsala, Sweden;
ACROSS, University of Tasmania, Hobart, Australia
4. Biogen, Research Triangle Park, NC, USA
5. Global Biotech Experts, LLC, Germantown, MD, USA
6. Merck & Co., Inc., West Point, PA, USA
7. Merck, Sharp & Dohme, Oss, The Netherlands
8. F. Hoffmann-La Roche Ltd., Basel, Switzerland
9. Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA

 

To download the full paper, click here.

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