Qualification of a chromatographic column: Why and how to do it

BioPharm International

Volumn 16, Issue 3, 2003, Pages 30-40

  Rathore, Anurag S ^c   Kennedy, Robert M ^d   O'Donnell, J Kevin ^a   Bemberis, Ivars ^b   Kaltenbrunner, Oliver ^e  

^a Tosoh SMD Inc   (United States)

^b MILLIPORE CORPORATION   (United States)

^c PFIZER INC   (United States)

^d GENERAL ELECTRIC COMPANY   (United States)

^e AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BUFFER; RESIN; TRACER;

ANALYTICAL EQUIPMENT; COLUMN CHROMATOGRAPHY; COMPUTER; DRUG PURIFICATION; FOOD AND DRUG ADMINISTRATION; INFRARED SPECTROSCOPY; REPRODUCIBILITY; REVIEW; SEPARATION TECHNIQUE;

EID: 0037341206     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (5)

1. Rathore, A.S. et al., "Process Validation: How Much to Do and When to Do It," BioPharm 15(10), 18-28 (October 2002).
2. Rathore, A.S. and Velayudhan, A., "Guidelines for Optimization and Scale-Up in Preparative Chromatography," BioPharm International 16(1), 34-42 (January 2003).
3. Van Deemter, J.J., Zuiderweg, F.J., and Klinkenberg, A., "Longitudinal Diffusion and Resistances to Mass Transfer as Causes of Nonideality in Chromatography," Chem. Eng. Sci. 5, 271-289 (1956).
4. Kaltenbrunner, O., Watler, P., and Yamamoto, S., "Column Qualification in Process Ion-Exchange Chromatography," Progress in Biotechnology: Bioseparation Engineering, Vol. 16, I. Endo et al. Eds. (Elsevier Science, Amsterdam, The Netherlands, 2000), pp. 201-206.
5. Stickel, J.J. and Fotopoulos, A., "Pressure-Flow Relationships for Packed Beds of Compressible Chromatography Media at Laboratory and Production Scale," Biotechnol. Prog. 17(4), 744-751 (2001).