Separation science is the key to successful biopharmaceuticals

Journal of Chromatography A

Volumn 1218, Issue 49, 2011, Pages 8836-8858

  Guiochon, Georges ^a   Beaver, Lois Ann ^b  

^a UNIVERSITY OF TENNESSEE   (United States)

^b LAB Enterprise   (United States)

Author keywords

Biopharmaceuticals; Modeling; Optimization; Preparative liquid chromatography

Indexed keywords

BIOPHARMACEUTICAL INDUSTRY; BIOPHARMACEUTICALS; COLUMN DESIGN; DESIGN AND OPERATIONS; DOWNSTREAM PROCESS; ECONOMIC CHANGE; EXPERIMENTAL CONDITIONS; PREPARATIVE CHROMATOGRAPHY; PREPARATIVE LIQUID CHROMATOGRAPHY; PRODUCTION COST; PRODUCTION PROCESS; REGULATORY REQUIREMENTS; SEPARATION SCIENCE;

CELL CULTURE; COLUMN CHROMATOGRAPHY; LIQUIDS; MODELS; OPTIMIZATION; PURIFICATION;

LIQUID CHROMATOGRAPHY;

ARTICLE; BIOREACTOR; ENZYME SPECIFICITY; EQUILIBRIUM CONSTANT; FLOW RATE; GLYCOSYLATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; HYDROGEN BOND; HYDROPHILICITY; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; ION EXCHANGE CHROMATOGRAPHY; ISOTHERM; LIQUID CHROMATOGRAPHY; MOLECULAR WEIGHT; PHARMACEUTICS; POROSITY; PREPARATIVE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; PROCESS DESIGN; PROCESS OPTIMIZATION; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN BINDING; PROTEIN PURIFICATION; SEPARATION TECHNIQUE; STOICHIOMETRY; THERMODYNAMICS; TRANSPORT KINETICS;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOLOGICAL AGENTS; BIOREACTORS; CHROMATOGRAPHY, LIQUID; HUMANS; PROTEINS; VACCINES;

EID: 82955219743     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2011.09.008     Document Type: Article

References (139)

1. Global Biopharmaceutical Market Report (2010-2015) by International Market Analysis Research and Consulting Group.
2. Royle L., Campbell M.P., Radcliffe C.M., White D.M., Harvey D.J., Abrahams J.L., Kim Y.-G., Henry G.W., Shadick N.A., Weinblatt M.E., Lee D.M., Rudd P.M., Dwek R.A. Anal. Biochem. 2008, 376:1-12.
3. Cleanrooms and associated controlled environments-part 1: classification of air cleanliness cleanroom standards, ISO 14644-1, 1999.
4. Baseline pharmaceutical engineering guides for new and renovated facilities, in: Biopharmaceuticals, vol. 6, ISPE, 2009, pp. Glossary updated 06-23-2010.
5. Chalk S., Taber R., Probst S., Gil P., Palberg T., Kennedy M., Rogalwicz J., Johnson J., Green K. BioPharm Int. 2011, 8(8):44-60.
6. Shukla A.A., Hubbard B., Tressel T., Guhan S., Low D. J. Chromatogr. B 2007, 848:28-39.
7. Kelley B.D., Tobler S.A., Brown P., Coffman J.L., Godavarti R., Iskra T., Switzer M., Vunnum S. Biotechnol. Bioeng. 2008, 101:553-565.
8. Suda E.J., Thomas K.E., Pabst T.M., Mensah P., Ramasubramanyan N., Gustafson M.E., Hunter A.K. J. Chromatogr. A 2009, 1216:5256-5264.
9. Bolton G.R., Violand B.N., Wright R.S., Sun S., Sunasara K., Watson K., Coffman J., Gallo C., Godavarti R. BioPharm Int. 2011, Suppl. 21:s8-s15.
10. Shukla A.A., Thömmes J. Trends Biotechnol. 2010, 28:253-261.
11. Voitl A., Müller-Späth T., Morbidelli M. J. Chromatogr. A 2010, 1217:5753-5760.
12. Ghose S., Hubbard B., Cramer S.M. J. Chromatogr. A 2006, 1122:144-152.
13. Guides produced by the International Conference on Harmonization. See ICH Q8, Q9 and Q10 and watch for Q11 at www.ich.org.
14. Rathore A.S. Trends Biotechnol. 2009, 27:546-552.
15. Rathore A.S., Mhatre R. Quality by Design for Biopharmaceuticals: Principles and Case Studies 2009, Wiley, Hoboken, NJ.
16. Kozlowski S., Swann P. Quality by Design for Biopharmaceuticals: Principles and Case Studies 2009, 9-27. Wiley, Hoboken, NJ. A.S. Rathore, R. Mhatre (Eds.).
17. Rathore A.S., Yu M., Yeboah S., Sharma A. Biotechnol. Bioeng. 2008, 100:306-318.
18. Rathore A.S., Wood R.A.S., Dermawan S. Biotechnol. Bioeng. 2008, 101:1366-1374.
19. Singh R., Gernaey K.V., Gani R. Comp. Chem. Eng. 2009, 33:22-42.
20. A-mab. A case study in bioprocess development - considerations for biotechnology product quality by design, www.ispe.org/PQLI_A_Mab_Case_Study_Version_2_1.pdf, 2009.
21. Guiochon G., Felinger A., Katti A., Shirazi D. Fundamentals of Nonlinear and Preparative Chromatography 2006, Elsevier, Amsterdam, The Netherlands.
22. Gritti F., Guiochon G. J. Chromatogr. A 2008, 1212:35-40.
23. Gritti F., Guiochon G. J. Chromatogr. A 2008, 1215:64-73.
24. Golshan-Shirazi S., Guiochon G. Anal. Chem. 1989, 61:1368.
25. Golshan-Shirazi S., Guiochon G. J. Chromatogr. 1990, 517:229-255.
26. Nfor B.K., Verhaert P.D.E.M., van der Wielen L.A.M., Hubbuch J., Ottens M. Trends Biotechnol. 2009, 27:673-679.
27. Guiochon G. J. Chromatogr. A 2002, 965:129-161.
28. Nfor B.K., Ahamed T., van Dedem G.W.K. J. Chem. Technol. Biotechnol. 2008, 83:124-132.
29. Karlsson D., Jakobsson N., Axelsson A., Nilsson B. J. Chromatogr. A 2004, 1055:29-39.
30. Melander W.R., Rassi Z.E., Horváth C. J. Chromatogr. 1989, 469:3.
31. Golshan-Shirazi S., Guiochon G. J. Phys. Chem. 1990, 94:495.
32. Golshan-Shirazi S., Guiochon G. J. Phys. Chem. 1989, 93:4143.
33. Kopaciewicz W., Rounds M.A., Regnier F. J. Chromatogr. 1983, 266:3.
34. Gallant S., Kundu A., Cramer S.M. Biotechnol. Bioeng. 1995, 47:355.
35. Lewus R.K., Carta G. AIChE J. 1999, 45:512.
36. Rhee H.-K., Amundson N.R. Chem. Eng. Sci. 1972, 27:199.
37. Quiñones I., Ford J.C., Guiochon G. Chem. Eng. Sci. 2000, 55:909.
38. Diack M., Guiochon G. Langmuir 1992, 8:1587.
39. El Fallah M.Z., Guiochon G. Biotechnol. Bioeng. 1992, 39:877.
40. Miyabe K., Guiochon G. Biotechnol. Progr. 1999, 15:740-752.
41. Miyabe K., Guiochon G. J. Chromatogr. A 1999, 866:147-171.
42. Sajonz H.G., Sajonz P., Zhong G., Guiochon G. Biotechnol. Progr. 1996, 12:380-396.
43. Sajonz P., Sajonz H.G., Zhong G., Guiochon G. Biotechnol. Progr. 1997, 13:170.
44. Rosen J.B. J. Chem. Phys. 1952, 20:387.
45. Kučera E. J. Chromatogr. 1965, 19:237.
46. Kaczmarski K., Gubernaz M., Zhou D., Guiochon G. Chem. Eng. Sci. 2003, 58:2325-2338.
47. Kaczmarski K., Antos D., Sajonz H., Sajonz P., Guiochon G. J. Chromatogr. A 2001, 925:1-17.
48. Gritti F., Guiochon G. Anal. Chem. 2006, 78:5329-5347.
49. Gritti F., Guiochon G. AICHE J. 2011, 57:333-345.
50. Gritti F., Guiochon G. AICHE J. 2010, 56:1495-1509.
51. Gritti F., Guiochon G. J. Chromatogr. A 2010, 1217:63506365.
52. Gritti F., Guiochon G. Chem. Eng. Sci. 2010, 65:6327-6340.
53. Gritti F., Guiochon G. AICHE J. 2011, 56:346-358.
54. Gritti F., Guiochon G. J. Chromatogr. A 2011, 1218:907-921.
55. Gritti F., Guiochon G. Chem. Eng. Sci. 2006, 61:7636-7650.
56. Gritti F., Guiochon G. J. Chromatogr. A 2011, 1218:3476-3488.
57. Miyabe K., Guiochon G. Adv. Chromatogr. 2000, 40:1-114.
58. Miyabe K., Guiochon G. J. Phys. Chem. B 2001, 105:9202-9209.
59. Miyabe K., Guiochon G. J. Phys. Chem. B 2004, 108:2987-2997.
60. Gritti F., Guiochon G. Anal. Chem. 2009, 81:2723-2736.
61. Hjertén S., Liao J.-L., Zhang R. J. Chromatogr. 1989, 473:273.
62. Liao J.-L., Zhang R., Hjertén S. J. Chromatogr. 1991, 586:21.
63. Hjertén S., Mohammad J., Nakazato K. J. Chromatogr. 1993, 646:121.
64. Rezeli M., Kilár F., Hjertén S. J. Chromatogr. 2006, 1109:100.
65. Svec F., Fréchet J.M. Anal. Chem. 1992, 64:820.
66. Svec F., Huber C.G. Anal. Chem. 2006, 78:2101.
67. Hilder E.F., Svec F., Fréchet J.M.J. J. Chromatogr. A 2004, 1044:3.
68. Jungbauer A., Hahn R. J. Chromatogr. A 2008, 1184:62-79.
69. Neff S., Jungbauer A. J. Chromatogr. A 2011, 1218:2374-2380.
70. Zandian M., Jungbauer A. J. Chromatogr. A 2009, 1216:5548-5556.
71. Yamamoto S., Nakanishi K., Matsuno R. Ion Exchange Chromatography of Proteins 1988, M. Dekker, New York, NY.
72. Yamamoto S. Biotechnol. Bioeng. 1995, 48:444.
73. Gritti F., Guiochon G. J. Chromatogr. A 2008, 1178:79-91.
74. Gritti F., Guiochon G. J. Chromatogr. A 2009, 1216:6124-6133.
75. Perez-Almodovar E.X., Carta G. J. Chromatogr. A 2009, 1216:8339-8347.
76. Tao Y., Carta G., Ferreira G., Robbins D. J. Chromatogr. A 2011, 1218:1519-1529.
77. Tao Y., Carta G., Ferreira G., Robbins D. J. Chromatogr. A 2011, 1218:1530-1537.
78. Fallah Z.E., Guiochon G. Biotechnol. Bioeng. 1992, 39:877-888.
79. Katiyar A., Ji L., Smirniotis P.G., Pinto N.G. Micropor. Mesopor. Mater. 2005, 80:311-320.
80. Katiyar A., Thiel S.W., Guliants V.V., Pinto N.G. J. Chromatogr. A 2010, 1217:1583-1588.
81. Felinger A., Zhou D., Guiochon G. J. Chromatogr. A 2003, 1005:35-49.
82. Gritti F., Guiochon G. J. Chromatogr. A 2005, 1099:1-42.
83. McCalley D.V. J. Chromatogr. A 2004, 1038:77-84.
84. Carta G., Jungbauer A. Protein Chromatography - Process Development and Scale-up 2010, Wiley-VCH, New York, NY.
85. Ahmad T., Gritti F., Lin B., Guiochon G. Anal. Chem. 2004, 76:977.
86. Fallah Z.E., Guiochon G. Anal. Chem. 1991, 63:2244-2252.
87. Young M.E., Carroad P.A., Bell R.L. Biotechnol. Bioeng. 1980, 22:947.
88. Quiñones I., Ford J.C., Guiochon G. Anal. Chem. 2000, 72:1495-1502.
89. Gritti F., Guiochon G. J. Chromatogr. A 2005, 1053:59-69.
90. Gritti F., Guiochon G. J. Chromatogr. A 2010, 1217:7677-7689.
91. Gritti F., Guiochon G. J. Chromatogr. A 2011, 1218:4632-4638.
92. Sternberg J.C. Adv. Chromatogr. 1966, 2:205-270.
93. Felinger A., Guiochon G. AIChE J. 1994, 40:594-605.
94. Felinger A., Horvath K. Presented at the 24th International Symposium on Preparative Chromatography 2011.
95. Lamb T.W., Whitman V.R. Soil Mechanics. SI Version 1979, Wiley, New York, NY.
96. Guiochon G., Farkas T., Guan-Sajonz H., Koh J., Sarker M., Stanley B., Yun T. J. Chromatogr. A 1997, 762:83.
97. Sofer G.K., Nyström L.E. Process Chromatography. A Practical Guide 1989, Academic Press, London, UK.
98. Sarker M., Katti A.M., Guiochon G. J. Chromatogr. A 1996, 719:275-289.
99. Yuan Q.S., Rosenfeld A., Root T.W., Kingenberg D.J., Lightfoot E.N. J. Chromatogr. A 1999, 831:149-165.
100. Yew B.G.Y., Ureta J., Shalliker R.A., Drumm E.C., Guiochon G. AICHE J. 2003, 49:642-664.
101. Fang Z. Encycl. Ind. Biotech. Biopr. Biosep. Cell Technol. 2010, 3123-3140.
102. Bansal N.P., Doremus N.R.H. Handbook of Glass Properties 1986, Academic Press, New York, NY.
103. Sticker J.J., Fotopoulos A. Biotechnol. Progr. 2001, 17:744-751.
104. Perez-Almodovar E.X., Carta G. J. Chromatogr. A 2009, 1216:8348-8354.
105. Hofmann M. J. Chromatogr. A 2003, 989:79-94.
106. Bemberis I., Noyes A., Natarajan V. BioPharm Int. Guide (July) 2003, 2:3-30.
107. Godbille E., Devaux P. J. Chromatogr. 1976, 122:317-329.
108. Sarker M., Yun T., Guiochon G. J. Chromatogr. A 1996, 728:3-13.
109. Hofmann M. J. Chromatogr. A 1998, 796:75-80.
110. Cherrak D.E., Al-Bokari M., Drumm E.C., Guiochon G. J. Chromatogr. A 2001, 943:15-31.
111. Guiochon G., Drumm E., Cherrak D. J. Chromatogr. A 1999, 835:41-58.
112. Guiochon G., Sarker M. J. Chromatogr. A 1995, 704:247-268.
113. Stanley B.J., Sarker M., Guiochon G. J. Chromatogr. A 1996, 741:175-184.
114. Cherrak D., Guiochon G. J. Chromatogr. A 2001, 911:147-166.
115. Guiochon G., Sarker M. J. Chromatogr. A 1996, 741:165-173.
116. Sarker M., Yun T., Guiochon G. J. Chromatogr. A 1996, 728:3-13.
117. Davies P.A., Bellhouse B.J. Chem. Eng. Sci. 1989, 44:452-455.
118. Ostergren K.C.E., Tragardh A.C., Enstad G.G., Mosby J. AIChE J. 1998, 44:2-12.
119. Mohammad A.W., Stevenson D.G., Wankat P.C. Ind. Eng. Chem. Res. 1992, 31:549-561.
120. Sofer G., Hagel L. Handbook of Process Chromatography: A Guide to Optimization, Scale-up and Validation 2007, Academic Press, San Diego, CA.
121. Hagel L., Jagschies G., Sofer G. Handbook of Process Chromatography 2007, Academic Press, New York, NY. 2nd ed.
122. Yew B.G.Y., Drumm E.C., Guiochon G. AICHE J. 2003, 49:626-641.
123. Pathak N., Norman C., Kundu S., Nulu S., Durst M., Fang Z. BioProcess Int. 2008, 6(10):72-81.
124. Guiochon G. J. Chromatogr. A 2007, 1168:101-168.
125. Kele M., Guiochon G. J. Chromatogr. A 2002, 960:19-49.
126. Jungbauer A., Hahn R. J. Chromatogr. A 2008, 1184:62-79.
127. Felinger A., Guiochon G. Biotchnol. Progr. 1993, 9:450-455.
128. Collins R.E. Flow of Fluids Through Porous Materials 1961, Rheinhold, New York, NY.
129. Mayfield K.J., Shalliker R.A., Sweeney A.P., Wong V., Guiochon G. J. Chromatogr. A 2005, 1080:124-131.
130. Shalliker R.A., Wong V., Guiochon G. J. Chromatogr. A 2007, 1161:121-131.
131. Shalliker R.A., Wong V., Guiochon G. J. Chromatogr. A 2009, 1216:787-793.
132. Arne Emneus N.I. J. Chromatogr. 1968, 32:243.
133. Moore J.C. Sep. Sci. Technol. 1970, 5:723.
134. Flodin P. J. Chromatogr. 1961, 5:103.
135. James P.M., Ouano A.C. J. Appl. Polym. Sci. 1973, 17:1455.
136. Moore J.C. Chromatogr. Sci. Ser. 1981, 19:13.
137. Yamamoto S., Nomura M., Sano Y. J. Chem. Eng. Jpn. 1986, 19:227.
138. Czok M., Katti A., Guiochon G. J. Chromatogr. 1991, 550:705.
139. Yau W.W., Kirkland J.J., Bly D.D. Modern Size Exclusion Liquid Chromatography 1979, Wiley, New York, NY.