Scaling down of biopharmaceutical unit operations - Part 2: Chromatography and filtration

BioPharm International

Volumn 18, Issue 4, 2005, Pages 58-64

  Rathore, Anurag ^a   Krishnan, Raj ^a   Tozer, Stephanie ^a   Smiley, Dave ^a   Rausch, Steve ^a   Seely, Jim ^b  

^a AMGEN INC   (United States)

^b Amgen Inc ^*

Author keywords

[No Author keywords available]

Indexed keywords

BUFFER; RESIN;

ARTICLE; AUTOMATION; CALIBRATION; CHROMATOGRAPHY; CONDUCTANCE; DRUG MANUFACTURE; ELUTION; FILTRATION; GEL PERMEATION CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ION EXCHANGE CHROMATOGRAPHY; PH MEASUREMENT; REPRODUCIBILITY; STATISTICAL ANALYSIS; TEMPERATURE DEPENDENCE;

EID: 17844410111     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. ICH, Quality of biotechnological products: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. International Conference on Harmonization Step 4 Endorsement 1997 March. Available at: www.fda.gov/cder/guideance/Q5A-fnl.pdf.
2. Yamamoto S, Nomura M, Sano Y, Resolution of proteins in linear gradient elution ion exchange and hydrophobic interaction chromatography. J. Chromatogr. 1987;409:101-110. O'Leary RM, Feuerheim D, Peers D, Xu Y, Blank GS. Determining the useful lifetime of chromatography resins, Biopharm Int. 2001 Sept.; 14 (9):10-18.4. Rathore AS, Velayudhan A. Scale-up guidelines for preparative chromatography, Biopharm Int'l. 2003 Jan.; 16 (1):34-42.
3. Yamamoto S, Nomura M, Sano Y, Resolution of proteins in linear gradient elution ion exchange and hydrophobic interaction chromatography. J. Chromatogr. 1987;409:101-110. O'Leary RM, Feuerheim D, Peers D, Xu Y, Blank GS. Determining the useful lifetime of chromatography resins, Biopharm Int. 2001 Sept.; 14 (9):10-18.4. Rathore AS, Velayudhan A. Scale-up guidelines for preparative chromatography, Biopharm Int'l. 2003 Jan.; 16 (1):34-42.
4. Yamamoto S, Nomura M, Sano Y, Resolution of proteins in linear gradient elution ion exchange and hydrophobic interaction chromatography. J. Chromatogr. 1987;409:101-110. O'Leary RM, Feuerheim D, Peers D, Xu Y, Blank GS. Determining the useful lifetime of chromatography resins, Biopharm Int. 2001 Sept.; 14 (9):10-18.4. Rathore AS, Velayudhan A. Scale-up guidelines for preparative chromatography, Biopharm Int'l. 2003 Jan.; 16 (1):34-42.
5. O'Leary RM, Feuerheim D, Peers D, Xu Y, Blank GS. Determining the useful lifetime of chromatography resins, Biopharm Int'l. 2001 Sept.; 14 (9):10-18.4.
6. Rathore AS, Velayudhan A. Scale-up guidelines for preparative chromatography, Biopharm Int'l. 2003 Jan.; 16 (1):34-42.
7. Rathore AS, Wang A, Menon M, Riske F, Campbell J, Goodrich E, Martin J. Optimization, scale-up and validation issues in filtration of biopharmaceuticals - Part I. Biopharm Int'l. 2004 August; 17 (8):50-58.
8. Lutz H, Siwak M, Carter J. Viral clearance performance and regulatory requirements, Poster, Biophex/Interphex, 2002 October 23-24; Santa Clara, CA.
9. Rathore AS, Sharma A, Zhang RJ, Chilin D. Scale-down modeling and characterization of a protein refolding step, Oral presentation, 227th American Chemical Society National Meeting, 2004 March 28-April 1; Anaheim, CA.