Chapter 7 Strategies for the development of process chromatography as a unit operation for the pharmaceutical industry

Handbook of Analytical Separations

Volumn 1, Issue , 2000, Pages 213-291

  Katti, Anita M ^a  

^a FeRx Incorporated   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 70350624975     PISSN: 15677192     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S1567-7192(00)80010-8     Document Type: Article

References (96)

1. Pisano G.P., and Wheelwright S.C. Harv. Bus. Rev. 73 (1995) 93
2. Basu P. Chem. Eng. Prog. 94 (1988) 75
3. ICH Q3a, Rockville, MD, January. FDA. Guideline for Industry Impurities in New Drug Substances (1996)
4. Anon. Chirality 4 (1992) 338
5. Iansih M., and West J. Harv. Bus. Rev. 75 (1977) 69
6. Kenant T. Chem. Eng. Prog. 95 (1988) 39
7. Parker H. Today's Chem. Work 4 (1995) 26
8. Cooper R., and Chew W.B. Harv. Bus. Rev.. 74 (1996) 89
9. Dwyer J.L. Bio/Technology 2 (1994) 957
10. Knox J.H., and Pyper M. J. Chromatogr. 363 (1986) 1
11. Golshan-Shirazi S., and Guiochon G. J. Chromatogr. 517 (1990) 229
12. Golshan-Shirazi S., and Guiochon G. Anal. Chem. 61 (1989) 1368
13. Katti A., and Guiochon G. Anal. Chem. 61 (1989) 982
14. Felinger A., and Guiochon G. J. Chromatogr. 591 (1992) 31
15. Jageland P., Magnusson J., and Bryntesson M. J. Chromatogr. 658 (1994) 497
16. Jandera P., Komers D., and Guiochon G. J. Chromatogr. 787 (1997) 13
17. Felinger A., and Guiochon G. J. Chromatogr. 752 (1996) 31
18. Felinger A., and Guiochon G. AICHE J. 40 (1994) 594
19. Colin H. Preparative and Production Scale Chromatography (1993), Marcel Dekker 11
20. Katti A., and Jageland P. Analusis 26 (1998) M38
21. Newburger J., and Guiochon G. J. Chromatogr. 484 (1989) 153
22. Newburger J., and Guiochon G. J. Chromatogr. 523 (1990) 63
23. Ma Z., Katti A., Lin B., and Guiochon G. J. Phys. Chem. 94 (1990) 6911
24. Golshan-Shirazi S., Huang J.-X., and Guiochon G. Anal. Chem. 63 (1991)
25. Katti A., Czok M., and Guiochon G. J. Chromatogr. 556 (1991) 205
26. Jacobson S., Golshan-Shirazi S., and Guiochon G. J. Am. Chem. Soc. 112 (1990) 6492
27. El Fallah M.Z., and Guiochon G. Biotechnol. Bioeng. 39 (1992) 877
28. Seidel-Morganstern A., and Guiochon G. Chem. Eng. Sci. 48 (1993) 2787
29. Frenz J., Van Der Schrieck E., and Horvath C. J. Chromatogr. 330 (1985) 1
30. Horvath C., Nahum A., and Frenz J. J. Chromatogr. 218 (1981) 365
31. Katti A., and Guiochon G. J. Chromatogr. 449 (1988) 25
32. Phillips M., Subramanian G., and Cramer S. J. Chromatogr. 454 (1988) 1
33. Subramanian G., Phillips M., and Cramer S. J. Chromatogr. 439 (1988) 341
34. Felinger A., and Guiochon G. J. Chromatogr. 609 (1992) 35
35. El Fallah M.Z., and Guiochon G. Biotechnol. Bioeng. 39 (1992) 877
36. Felinger A., and Guiochon G. Biotechnol. Bioeng. 41 (1993) 134
37. Katti A., Dose E., and Guiochon G. J. Chromatogr. 540 (1991) 1
38. Felinger A., and Guiochon G. Biotechnol. Prog. 12 (1996) 638
39. Felinger A., and Guiochon G. J. Chromatogr. 796 (1998) 59
40. Seidel-Morganstern A. Analusis Magazine 26 (1998) M46
41. Blehaut J., and Nicoud R.-M. Analusis Magazine 26 (1998) M60
42. Zhong G., and Guiochon G. Chem. Eng. Sci. 52 (1997) 4403
43. Zhong G., Yun T., Khattabi S., and Guiochon G. Chromatographia 45 (1997) 109
44. Yun T., Zhong G., and Guiochon G. AICHE J. 43 (1997) 935
45. Sinclair G. Chem. Eng. Prog. 95 (1999) 27
46. Ayers J.B. Chem. Eng. Prog. 95 (1999) 31
47. Mukesh D. Chem. Eng. Prog. 95 (1999) 24
48. Winter O. Ind. Eng. Chem. 61 (1969) 45
49. March 27. Krieger J.H. Chem. Eng. News (1995) 50
50. Swartz M.E., and Krull I.S. Analytical Regulatory and Validation Compliance Primer (1997), Marcel Dekker
51. Clark D.G. Chem. Eng. Prog. 93 12 (1997) 69
52. Drucker P.F. Harv. Bus. Rev. 72 (1994) 95
53. Majchrzak A., and Wang Q. Harv. Bus. Rev. 74 (1996) 93
54. Kent H.K., Clark K.B., Holloway C.A., and Wheelright S.C. Harv. Bus. Rev. 72 (1994) 110
55. Senge P.M. Sloan Manage. Rev. 32 (1990) 1
56. Khurana A., and Rosenthal S. Sloan Manage. Rev. 38 (1997) 103
57. April 13. Frohman M.A. Ind. Week (1995) 21
58. Ghoshal S., and Bartlett C.A. Harv. Bus. Rev. 73 (1995) 86
59. Leonard-Barton D., Bowen H.K., Clark K.B., Halloway C.A., and Wheelwright S.C. Harv. Bus. Rev. 72 (1994) 121
60. Schneider W.E. The Re-engineering Alternative (1994), McGraw Hill
61. Sathe V. Culture and Related Corporate Realities (1985), Richard D. Irwin 86.
62. Dr. Sally (Sara) Sporer, Sasari and Company PLLC. Boulder CO 80302.
63. Guiochon G., and Ghodbane S. J. Phys. Chem. 92 (1988) 3682
64. Golshan-Shirazi S., and Guiochon G. J. Phys. Chem. 93 (1989) 4143
65. Guiochon G., Ghodbane S., Golshan-Shirazi S., Huang J.-X., Katti A., Lin B.-C., and Ma Z. Talanta 36 (1989) 19
66. Guiochon G., Golshan-Shirazi S., and Katti A. Fundamentals of Preparative and Nonlinear Chromatography (1994), Academic Press
67. Meyer V. Practical High Performance Liquid Chromatography (1988)
68. Knox J.H. J. Chromatogr. Sci. 15 (1977) 352
69. Van Deemter J.J., Zuiderweg F.J., and Klinkenberg A. Chem. Eng. Sci. 5 (1956) 271
70. J.E.Golay M. Gas Chromatography 1958 (1959), Butterworths 36
71. Horvath C., and Lin H.J. J. Chromatogr. 149 (1978) 43
72. O. Dapremont, G.B. Cox, V. Briand, PREP'98, 1998 International Symposium, Exhibit and Workshops on Preparative Chromatography, Ion Exchange, Adsorption/Des May 31-June 3, Washington D.C., 129.
73. Katti A., and Jageland P. Analusis Magazine 26 (1998) M38
74. Jageland P., Magnusson J., and Bryntesson M. J. Chromatogr. 658 (1994) 497
75. Peters M.S., and Timmerhaus K.D. Plant Design and Economics for Chemical Engineers. 3rd ed. (1980), McGraw-Hill Book 167
76. Burdick Jackson Laboratories Inc. High Purity Solvent Guide (1984) 80
77. Lewis Sr. R.J. Hazardous Chemicals Desk Reference. 4th ed. (1997), Wiley
78. In: Weast R.C. (Ed). CRC Handbook of Chemistry and Physics. 56th ed. (1975), CRC Press D-4
79. QC Bulk Pharmaceutical Work Group, Quality Steering Committee and PhRMA Science and Regulatory Section. Pharm. Technol. 19 (1995) 22
80. QC Bulk Pharmaceutical Work Group, Quality Steering Committee and PhRMA Science and Regulatory Section. Pharm Technol. 20 (1996) 50
81. Quality Control Reports. Gold Sheet 29 4 (1995)
82. Immel B. BioPharm 9 (1996) 55
83. Kirkendahl R. Good Manufacturing Practice Compliance through Product/Process Development and Scale Up Phase, PREP'99. Sunday, May 23, San Francisco, CA (1999)
84. ISPE San Francisco/Bay area Chapter. Pharm. Eng. 18 1 (1998) 2
85. U.S. Food and Drug Administration, Guidance for Industry, Manufacture, Processing or Holding of Active Pharmaceutical Ingredients, Discussion Draft - Not for Implementation, August 1996.
86. Noren A.R., Naik N., Wieczorek G.M., and Basu P.K. Chem. Eng. Prog. 95 (1999) 39
87. Guide to the Inspection of Bulk Pharmaceuticals, 21CFR 211. U.S. Food and Drug Administration, Washington, DC, Sept., 1991.
88. Process Safety Management of Highly Hazardous Chemicals; Explosives and Blasting Agents; Final Rule, 29 CFR Part 1910, U.S. Occ. Safety Health Admin., Washington, DC, Feb. 24, 1992.
89. Sofer G. BioPharm 10 (1997) 36
90. Murphy R., and Seely R.J. Validation of Bulk Pharmaceuticals (1997), Interpharm Press 271
91. G. Mann, Reflections on Packing Medias, PREP'95, Washington DC, June 11-14, 305.
92. Stanley B.J., Foster C.R., and Guiochon G. J. Chromatogr. 761 (1997) 41
93. Katti A., and Guiochon G. Anal. Chem. 61 (1989) 982
94. Jandera P., and Guiochon G. J. Chromatogr. 588 (1991) 1
95. Czok M., Katti A.M., and Guiochon G. J. Chromatogr. 550 (1991) 705
96. Broyles B.S., Shalliker R.A., Cherrak D., and Guiochon G. J. Chromatogr. 822 (1988) 173