Multivariate analysis of transition analysis calculations applied to evaluate trends and changes in chromatography column packed bed integrity at BiogenIdec

BIOT 111

Benjamin Gilbert, benjamin.gilbert@biogenidec.com, Manufacturing Sciences, Biogen Idec Inc, PO Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709
With increasing values of biologic products and higher cost chromatography media, improved methods of evaluating chromatography bed integrity are needed to minimize the risk of substantial loss which might accompany a packed bed failure. Traditional HETP pulse test methods used in the industry do not provide the sensitivity to trend or predict bed failures. BiogenIdec is using Transition Analysis calculations in Principal Component Analysis to trend chromatography bed integrity.
 

Commercialization of Biologics: Data Management & Process Modeling in Support of Commercial Processes
3:00 PM-5:20 PM, Monday, August 20, 2007 BCEC -- 107C, Oral

Division of Biochemical Technology

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007