A safe, effective, and facility compatible cleaning in place procedure for affinity resin in large-scale monoclonal antibody purification

Journal of Chromatography A

Volumn 1308, Issue , 2013, Pages 86-95

  Wang, Lu ^a   Dembecki, Jill ^a   Jaffe, Neil E ^a   O'Mara, Brian W ^a   Cai, Hui ^a   Sparks, Colleen N ^a   Zhang, Jian ^a   Laino, Sarah G ^a   Russell, Reb J ^a   Wang, Michelle ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Cleaning in place (CIP); Commercial scale purification; Facility compatible; High throughput screen; MabSelect; Resin life cycle

Indexed keywords

BIOPHARMACEUTICAL INDUSTRY; CLEANING IN PLACE; HIGH THROUGHPUT SCREENING; HIGH-THROUGHPUT SCREENS; LARGE SCALE MANUFACTURE; MABSELECT; MONOCLONAL ANTIBODY PURIFICATION; PURIFICATION PROCESS;

AFFINITY CHROMATOGRAPHY; CAUSTIC SODA; DRUG PRODUCTS; LIFE CYCLE; MANUFACTURE; MONOCLONAL ANTIBODIES; PROTEINS; PURIFICATION; RESINS; SODIUM CHLORIDE; STEEL CONTAINERS;

CLEANING;

BENZYL ALCOHOL; MONOCLONAL ANTIBODY; RESIN; SODIUM CHLORIDE; SODIUM HYDROXIDE; SODIUM SULFATE; STAINLESS STEEL;

AFFINITY CHROMATOGRAPHY; ANIMAL CELL; ARTICLE; CLEANING; CLEANING IN PLACE; CONTROLLED STUDY; CORROSION; DRUG PURIFICATION; HIGH THROUGHPUT SCREENING; NONHUMAN; PRIORITY JOURNAL; PROCESS OPTIMIZATION;

EID: 84883052382     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2013.07.096     Document Type: Article

References (21)

1. Fahrner R.L., Knudsen H.L., Basey C.D., Galan W., Feuerhelm D., Vanderlaan M., Blank G.S. Biotechnol. Genet. Eng. Rev. 2001, 18:301.
2. Shukla A.A., Hubbard B., Tressel T., Guhan S., Low D. J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci. 2007, 848:28.
3. Low D., O'Leary R., Pujar N.S. J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci. 2007, 848:48.
4. Hober S., Nord K., Linhult M. J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci. 2007, 848:40.
5. Kelley B. Biotechnol. Prog. 2007, 23:995.
6. J. Immunother. 1997, 20:214.
7. Gulich S., Linhult M., Nygren P., Uhlen M., Hober S. J. Biotechnol. 2000, 80:169.
8. Linhult M., Gulich S., Graslund T., Simon A., Karlsson M., Sjoberg A., Nord K., Hober S. Proteins 2004, 55:407.
9. Girot P., Moroux Y., Duteil X.P., Nguyen C., Boschetti E. J. Chromatogr. 1990, 510:213.
10. Hale G., Drumm A., Harrison P., Phillips J. J. Immunol. Methods 1994, 171:15.
11. Johansson H.J., Bergenstrahle A., Rodrigo G., Oberg K. ACS Annual Conference 1998.
12. Jiang C., Liu J., Rubacha M., Shukla A.A. J. Chromatogr. A 2009, 1216:5849.
13. Alavi A., Cottis R.A. Corros. Sci. 1987, 27:443.
14. Lute S., Brorson K. J. Chromatogr. A 2009, 1216:3774.
15. Rogers M., Hiraoka-Sutow M., Mak P., Mann F., Lebreton B. J. Chromatogr. A 2009, 1216:4589.
16. H. Houshmand, in US2009/0209656A1, USA Patent, 2009.
17. Swinnen K., Krul A., Goidsenhoven I.V., Tichelt N.V., Roosen A., Houdt K.V. J. Chromatogr. B 2007, 848:97.
18. Zucchi F., Trabanelli G., Grassi V., Frignani A. Corrosion 2004, 60:362.
19. Saadawy M. ISRN Corros. 2012, Article ID 916367.
20. Zhang Y., Cremer P.S. Curr. Opin. Chem. Biol. 2006, 10:658.
21. F.D. A, ICH Guidance for Industry Q3A Impurities in New Drug Substances, Rockville, MD, 2008.