Applying high-throughput methods to develop a purification process for a highly glycosylated protein

Biotechnology Journal

Volumn 7, Issue 10, 2012, Pages 1242-1255

  Sanaie, Nooshafarin ^a   Cecchini, Douglas ^a   Pieracci, John ^a  

^a BIOGEN   (United States)

Author keywords

Cation exchange chromatography (CEX); Chromatography; Downstream processing; High throughput process development (HTPD); Hydrophobic interaction chromatography (HIC)

Indexed keywords

96-WELL; 96-WELL PLATE; CATION EXCHANGE CHROMATOGRAPHY; CATION EXCHANGES; CHROMATOGRAPHY COLUMNS; DOWNSTREAM-PROCESSING; FILTER PLATES; GLYCOFORMS; GLYCOSYLATED; HIGH-THROUGHPUT; HIGH-THROUGHPUT METHOD; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; INPUT PARAMETER; MICRO-SCALES; OPERATING CONDITION; OPERATING RANGES; PACKED COLUMN; PROCESS CONDITION; PROCESS DEVELOPMENT; PROCESS KNOWLEDGE; PROCESS PERFORMANCE; PRODUCT RECOVERY; PURIFICATION PROCESS; SCREENING TOOL;

CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; POSITIVE IONS; PROTEINS; PURIFICATION;

COLUMN CHROMATOGRAPHY;

GLYCOSYLATED PROTEIN;

ARTICLE; BINDING AFFINITY; FILTER; HIGH THROUGHPUT SCREENING; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; INTERMETHOD COMPARISON; ION EXCHANGE CHROMATOGRAPHY; PRIORITY JOURNAL; PROTEIN ANALYSIS; PROTEIN BINDING; PROTEIN PURIFICATION;

CHROMATOGRAPHY, ION EXCHANGE; CHROMATOGRAPHY, LIQUID; GLYCOPROTEINS; HIGH-THROUGHPUT SCREENING ASSAYS; HYDROGEN-ION CONCENTRATION; HYDROPHOBIC AND HYDROPHILIC INTERACTIONS; SODIUM CHLORIDE;

EID: 84867215894     PISSN: 18606768     EISSN: 18607314     Source Type: Journal    
DOI: 10.1002/biot.201200170     Document Type: Article

References (19)

1. Coffman, J. L., Kramarczyk, J. F., Kelley, B. D., High-throughput screening of chromatographic separations: I. Method development and column modeling. Biotechnol. Bioeng. 2008, 100, 605-618.
2. Lacki, K. M., Bergander, T., Gronberg, A., Oberg, K., in: Meeting, A. N. (Ed.), Abstract of Papers, BIOT-470, Boston, MA, United States 2007, pp. BIOT-470.
3. Nilsson-Valimaa, K., Rodrigo, G., Engstrand, C., Forss, A., Lacki, K. M., BIOT 470-High throughput process development: Development of chromatographic steps for removal of aggregates in an antibody purification process. Abstracts of Papers of the American Chemical Society 2008, 236.
4. Chhatre, S., Titchener-Hooker, N. J., Review: Microscale methods for high-throughput chromatography development in the pharmaceutical industry. J. Chem. Technol. Biotechnol. 2009, 84, 927-940.
5. Bergander, T., Nilsson-Vaelimaa, K., Oberg, K., Lacki, K. M., High-throughput process development: Determination of dynamic binding capacity using microtiter filter plates filled with chromatography resin. Biotechnol. Prog. 2008, 24, 632-639.
6. Kelley, B. D., Switzer, M., Bastek, P., Kramarczyk, J. F. et al., High-throughput screening of chromatographic separations: IV. Ion-exchange. Biotechnol. Bioeng. 2008, 100, 950-963.
7. Brochier, V. B., Schapman, A., Santambien, P., Britsch, L., Fast purification process optimization using mixed-mode chromatography sorbents in pre-packed mini-columns. J. Chromatogr. A 2008, 1177, 226-233.
8. Wensel, D. L., Kelley, B. D., Coffman, J. L., High-throughput screening of chromatographic separations: III. Monoclonal antibodies on ceramic hydroxyapatite. Biotechnol. Bioeng. 2008, 100, 839-854.
9. Kramarczyk, J. F., Kelley, B. D., Coffman, J. L., High-throughput screening of chromatographic separations: II. Hydrophobic interaction. Biotechnol. Bioeng. 2008, 100, 707-720.
10. Shukla A. K., Shukla M. M., Shukla A. M., Incision-based filtration/separation pipette tip. US Patent 7276158 B1, 2007.
11. Williams, J. G., Tomer, K. B., Disposable chromatography for a high-throughput nano-ESI/MS and nano-ESI/MS-MS platform. J. Am. Soc. Mass Spectrom. 2004, 15, 1333-1340.
12. Wenger, M. D., DePhillips, P., Bracewell, D. G., A microscale yeast cell disruption technique for integrated process development strategies. Biotechnol. Prog. 2008, 24, 606-614.
13. Kaltenbrunner, O., Jungbauer, A., Yamamoto, S., Prediction of the preparative chromatography performance with a very small column. J. Chromatogr. A 1997, 760, 41-53.
14. Nagrath, D., Xia, F., Cramer, S. M., Characterization and modeling of nonlinear hydrophobic interaction chromatographic systems. J. Chromatogr. A 2011, 1218, 1219-1226.
15. Rege, K., Pepsin, M., Falcon, B., Steele, L., Heng, M., High-throughput process development for recombinant protein purification. Biotechnol. Bioeng. 2006, 93, 618-630.
16. Romero, J., Chrostowski, J., De Vilmorin, P. G., Yun Case, J., Method of isolating biomacromolecules using low pH and divalent cations. US Patent 2010/0145022 A1, 2010.
17. Cramer, S. M., Rege, K., Dordick, J. S., High throughput screening of potential displacer molecules. US Patent 6881540 B2, 2005.
18. Mazza, C. B., Rege, K., Breneman, C. M., Sukumar, N. et al., High-throughput screening and quantitative structure-efficacy relationship models of potential displacer molecules for ion-exchange systems. Biotechnol. Bioeng. 2002, 80, 60-72.
19. Laemmli, U. K., Clevage of structural proteins during the assembly of the head of bacteriophage T4. Nat. Protocols 1970, 227.