A practical strategy for using miniature chromatography columns in a standardized high-throughput workflow for purification development of monoclonal antibodies

Biotechnology Progress

Volumn 30, Issue 3, 2014, Pages 626-635

  Welsh, John P ^a   Petroff, Matthew G ^a   Rowicki, Patricia ^a   Bao, Haiying ^a   Linden, Thomas ^a   Roush, David J ^a   Pollard, Jennifer M ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

High throughput screening; Miniature column chromatography; Monoclonal antibodies; Protein purification

Indexed keywords

MONOCLONAL ANTIBODIES; PACKED BEDS; PLANNING; PREDICTIVE ANALYTICS; PURIFICATION; SEPARATION;

CHROMATOGRAPHY PURIFICATIONS; HIGH THROUGHPUT SCREENING; HIGH-THROUGHPUT TECHNIQUE; HIGHTHROUGHPUT PROCESS DEVELOPMENT (HTPD); MONOCLONAL ANTIBODIES (MAB); OPTIMAL OPERATING CONDITIONS; PROTEIN PURIFICATION; SEPARATION CHARACTERISTICS;

COLUMN CHROMATOGRAPHY;

MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

BIOSYNTHESIS; CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; ISOLATION AND PURIFICATION; WORKFLOW;

ANTIBODIES, MONOCLONAL; CHROMATOGRAPHY; HIGH-THROUGHPUT SCREENING ASSAYS; RECOMBINANT PROTEINS; WORKFLOW;

EID: 84923011054     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1905     Document Type: Article

References (44)

1. Dimitrov DS. Therapeutic proteins. Methods Mol Biol. 2012; 899:1-26.
2. Marichal-Gallardo PA, Alvarez MM. State-of-the-art in downstream processing of monoclonal antibodies: process trends in design and validation. Biotechnol Prog. 2012;28:899-916.
3. Fahrner RL, Knudsen HL, Basey CD, Galan W, Feuerhelm D, Vanderlaan M, Blank GS. Industrial purification of pharmaceutical antibodies: development, operation, and validation of chromatography processes. Biotechnol Genet Eng Rev. 2001;18:301-327.
4. Kelley BD, Tobler SA, Brown P, Coffman JL, Godavarti R, Iskra T, Switzer M, Vunnum S. Weak partitioning chromatography for anion exchange purification of monoclonal antibodies. Biotechnol Bioeng. 2008;101:553-566.
5. Shukla AA, Hubbard B, Tressel T, Guhan S, Low D. Downstream processing of monoclonal antibodies-application of platform approaches. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;848:28-39.
6. Chhatre S, Titchener-Hooker NJ. Review: microscale methods for high-throughput chromatography development in the pharmaceutical industry. J Chem Technol Biotechnol. 2009;84:927-940.
7. Lacki KM, Brekkan E. High throughput screening techniques in protein purification. Methods Biochem Anal 2011;54:489-506.
8. Coffman JL, Kramarczyk JF, Kelley BD. High-throughput screening of chromatographic separations: I. Method development and column modeling. Biotechnol Bioeng. 2008;100:605-618.
9. Rege K, Pepsin M, Falcon B, Steele L, Heng M. High-throughput process development for recombinant protein purification. Biotechnol Bioeng. 2006;93:618-630.
10. Lacki KM. High-throughput process development of chromatography steps: advantages and limitations of different formats used. Biotechnol J. 2012;7:1192-1202.
11. Bhambure R, Kumar K, Rathore AS. High-throughput process development for biopharmaceutical drug substances. Trends Biotechnol. 2011;29:127-135.
12. Wenger MD, Dephillips P, Price CE, Bracewell DG. An automated microscale chromatographic purification of virus-like particles as a strategy for process development. Biotechnol Appl Biochem. 2007;47:131-139.
13. Osberghaus A, Drechsel K, Hansen S, Hepbildikler SK, Nath S, Haindi M, Von Lieres E, Hubbuch J. Model-integrated process development demonstrated on the optimization of a robotic cation exchange step. Chem Eng Sci. 2012;76:129-139.
14. Susanto A, Knieps-Grunhagen E, von Lieres E, Hubbuch J. High throughput screening for the design and optimization of chromatographic processes: assessment of model parameter determination from high throughput compatible data. Chem Eng Technol. 2008;31:1846-1855.
15. Wiendahl M, Wierling OS, Nielsen J, Christensen DF, Kraup J, Staby A, Hubbuch J. High throughput screening for the design and optimization of chromatographic processes-miniaturization, automation, and parallelization of breakthrough and elution studies. Chem Eng Technol. 2008;31:893-903.
16. Yuan QS, Rosenfeld A, Root TW, Klingenberg DJ, Lightfoot EN. Flow distribution in chromatographic columns. J Chromatogr A. 1999;831:149-165.
17. McCue JT, Cecchini D, Chu C, Liu WH, Spann A. Application of a two-dimensional model for predicting the pressure-flow and compression properties during column packing scale-up. J Chromatogr A. 2007;1145:89-101.
18. Knox JH, Laird GR, Raven PA. Interaction of radial and axial dispersion in liquid chromatography in relation to the "infinite diameter effect". J Chromatogr A. 1976:129-145.
19. Bergander T, Nilsson-Valimaa K, Oberg K, Lacki KM. Highthroughput process development: determination of dynamic binding capacity using microtiter filter plates filled with chromatography resin. Biotechnol Prog. 2008;24:632-639.
20. Carta G, Ubiera AR, Pabst TM. Protein mass transfer kinetics in ion exchange media: measurements and interpretations. Chem Eng Technol. 2005;28:1252-1264.
21. Langmuir I. The adsorption of gases on plane surfaces of glass, mica and platinum. J Am Chem Soc. 1918;40:1391-1403.
22. LeVan MD, Carta G. In: Green DW, editor. Adsorption and Ion Exchange. Perry's Chemical Engineers' Handbook, 8th ed. New York: McGraw-Hill; 2007.
23. Foo RC, Rice RG. On the prediction of ultimate separation in parametric pumps. AIChE J 1975, 21:1149-1158.
24. Tyn MT, Gusek TW. Prediction of diffusion coefficients of proteins. Biotechnol Bioeng. 1990, 35:327-338.
25. Hagel L, Jagschies G, Sofer GK. Handbook of Process Chromatography: Development, Manufacturing, Validation, and Economics, 2nd ed. Amsterdam, Netherlands: Academic Press, Elsevier; 2007.
26. Hahn R, Bauerhansl P, Shimahara K, Wizniewski C, Tscheliessnig A, Jungbauer A. Comparison of protein A affinity sorbents II. Mass transfer properties. J Chromatogr A 2005; 1093:98-110.
27. Hahn R, Schlegel R, Jungbauer A. Comparison of protein A affinity sorbents. J Chromatogr B Analyt Technol Biomed Life Sci. 2003;790:35-51.
28. Teeters M, Bezila D, Alred P, Velayudhan A. Development and application of an automated, low-volume chromatography system for resin and condition screening. Biotechnol J 2008;3: 1212-1223.
29. Wankat PC, Koo YM. Scaling rules for isocratic elution chromatography. AIChE J 1988;34:1006-1019.
30. 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.
31. Tao Y, Carta G. Rapid monoclonal antibody adsorption on dextran-grafted agarose media for ion-exchange chromatography. J Chromatogr A 2008;1211:70-79.
32. Bowes BD, Lenhoff AM. Protein adsorption and transport in dextran-modified ion-exchange media. II. Intraparticle uptake and column breakthrough. J Chromatogr A 2011;1218:4698-4708.
33. Gritti F, Guiochon G. A protocol for the measurement of all the parameters of the mass transfer kinetics in columns used in liquid chromatography. J Chromatogr A 2010;1217:5137-5151.
34. Staby A, Sand MB, Hansen RG, Jacobsen JH, Andersen LA, Gerstenberg M, Bruus UK, Jensen IH. Comparison of chromatographic ion-exchange resins. III. Strong cation-exchange resins. J Chromatogr A 2004;1034:85-97.
35. Treier K, Hansen S, Richter C, Diederich P, Hubbuch J, Lester P. High-throughput methods for miniaturization and automation of monoclonal antibody purification processes. Biotechnol Prog. 2012;28:723-732.
36. Carta G. Predicting protein dynamic binding capacity from batch adsorption tests. Biotechnol J 2012;7:1216-1220.
37. Kramarczyk JF, Kelley BD, Coffman JL. High-throughput screening of chromatographic separations: II. Hydrophobic interaction. Biotechnol Bioeng. 2008;100:707-720.
38. Wensel DL, Kelley BD, Coffman JL. High-throughput screening of chromatographic separations: III. Monoclonal antibodies on ceramic hydroxyapatite. Biotechnol Bioeng. 2008;100:839-854.
39. Nfor BK, Noverraz M, Chilamkurthi S, Verhaert PD, van der Wielen LA, Ottens M. High-throughput isotherm determination and thermodynamic modeling of protein adsorption on mixed mode adsorbents. J Chromatogr A 2010;1217:6829-6850.
40. Kelley B. Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol Prog. 2007;23:995-1008.
41. Ishihara T, Kadoya T, Endo N, Yamamoto S. Optimization of elution salt concentration in stepwise elution of protein chromatography using linear gradient elution data. Reducing residual protein A by cation-exchange chromatography in monoclonal antibody purification. J Chromatogr A 2006;1114:97-101.
42. Bensch M, Wierling PS, von Lieres E, Hubbuch J. High throughput development of chromatographic phases for rapid process development. Chem Eng Technol. 2005;28:1274-1284.
43. Konstantinidis S, Heldin E, Chhatre S, Velayudhan A, Titchener-Hooker N. Strategic assay deployment as a method for countering analytical bottlenecks in high throughput process development: case studies in ion exchange chromatography. Biotechnol Prog. 2012;28:1292-1302.
44. Wierling PS, Bogumil R, Knieps-Grunhagen E, Hubbuch J. High-throughput screening of packed-bed chromatography coupled with SELDI-TOF MS analysis: monoclonal antibodies versus host cell protein. Biotechnol Bioeng. 2007;98:440-450.