Antibody Purification: Drivers of Change

Process Scale Purification of Antibodies

Volumn , Issue , 2008, Pages 407-426

  Pujar, Narahari ^a   Low, Duncan ^b   O'leary, Rhona ^c  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Genentech ^*

^c GENENTECH INC   (United States)

Author keywords

Antibody purification drivers of change; Changing regulatory environment; Economic drivers and QbD and design space

Indexed keywords

EID: 84890681844     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470444894.ch20     Document Type: Chapter

References (63)

1. Luan, Y.-T., Wang, W., Nolan, R., Drapeau, D. (2006). Defined medium development for high yielding mammalian cell culture processes. Presentation at the IBC and Bioprocess International Conference, San Francisco, CA, 2006
2. Fahrner, R.L., Knudsen, H.L., Basey, C.D., Galan, W., Feuerhelm, D., Vanderlaan, M., Blank, G. (2001). Industrial purification of pharmaceutical antibodies: develop ment, operation, and validation of chromatography processes. Biotechnology and Genetic Engineering Reviews 18, 301-327
3. Shukla, A., Hubbard, B., Tressel, T., Guhan, S., Low, D. (2007). Downstream process ing of monoclonal antibodies -Application of platform approaches. Journal of Chro matography B 848, 28-39
4. Kelley, B. (2007). Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnology Progress 23, 995-1008
5. Farid, S. (2007). Process economics of industrial monoclonal antibody manufacture. Journal of Chromatography B 848, 8-18
6. Low, D., O'Leary, R., Pujar, H. (2007). The future of antibody purification. Journal of Chromatography B 848, 48-63
7. Thömmes, J., Etzel, M. (2007). Alternatives to chromatographic separations. Bio technology Progress 23, 42-45
8. Macher, J., Nickerson, J. (2006). Pharmaceutical Industry Wastes $50 Billion a Year due to Inefficient Manufacturing. McDonough School of Business, Georgetown University, Washington, DC, and Olin School of Business, Washington University, St. Louis, MO
9. Seely, R., Seely, J.E. (2003). A rational, step-wise approach to process characteriza tion. BioProcess International 1, 24-34
10. Van Hoek, P., Harms, I, Wang, X., Rathore, A. (2008). Case study on definition of design space for a microbial fermentation step. In Rathore, A.S., Mhatre, R. (eds.) Quality by Design For Biopharmaceuticals: Perspectives and Case Studies, Wiley Interscience (in press)
11. Kaltenbrunner, O., Giaverini, O., Woehle, D., Asenjo, J. (2008). Application of chro matographic theory for process characterization towards validation for an ion - exchange operation. Biotechnology and Bioengineering 98, 201-210
12. Mollerup, I, Hansen,T., Kidal, S., Staby, A. (2007). Quality by design-Thermody- namic modeling of chromatographic separation of proteins. Journal of Chromatog raphy A 1177, 200-206
13. Watts, C., Clark J. (2006). PAT: Driving the future of pharmaceutical quality. Journal of Process Analytical Technology 3, 6-9
14. Kenney, A., Chase, H. (1987). Automated production scale affinity purification of monoclonal antibodies. Journal of Chemical Technology and Biotechnology 39, 179-182
15. Aldington, S, Bonnerjea, J. (2007). Scale-up of monoclonal antibody purification processes. Journal of Chromatography B 848, 64-78
16. Hutton, D., Barnwell, P., Taylor L., Low, D., Mann, F. (2003). Characterization of animal free protein a to demonstrate equivalence in support of regulatory approval . Presentation at Recovery of Biological Products XI, Banff, Canada, 2003
17. Lebreton, B., Lazzarechi, K., McDonald, P., O'Leary R. (2003). Performance evalu ation of Prosep vA, an animal-free Protein A resin. Presentation at Recovery of Biological Products XI, Banff, Canada, 2003
18. O'Leary, R. (2003). Post-approval changes: A necessary evil in the product lifecycle. Presentation at Recovery of Biological Products XI, Banff, Canada, 2003
19. ASTM standard E2500 -07 (2007). Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. ASTM International, West Conshohocken, PA
20. Chew, R., Petko, D. (2007). Commissioning and qualification: A new ASTM stan dard - GMP regulations. Pharmaceutical Engineering 27, 38-50
21. Wenger, M.D., DePhillips, P., Price, C.E., Bracewell, D.E. (2006). Bioprocess on a deck: An automated microscale chromatographic purification to rapidly evaluate Saccharomyces cerevisiae fermentation performance in the optimization of HPV virus-like particle expression. Presentation at the 232nd ACS National Meeting, San Francisco, CA, 2006
22. Girard, P., Joradon, M., Tsao, M., Wurm, F. (2001). Small-scale bioreactor system for process development and optimization. Biochemical Engineering Journal 7, 117-119
23. Lye, G., Ayazi-Shamlou, P., Baganz, F., Dalby, P., Woodley, I (2003). Accelerated design of bioconversion process using automated microscale processing technique. Trends in Biotechnology 21, 29-37
24. Stokelman, A., Slaff, G., Zarur, A, Rodgers, S., Low, D. Seewoester, T. (2005). High throughput cell culture experimentation with Bioprocessors Simcell platform. Pre sentation at Biochemical Engineering XV, Harrison Hot Springs, BC, 2005
25. Browne, S.M., Al-Rubeai, M. (2007) Selection methods for high -producing mam malian cell lines. Trends in Biotechnology 25, 425-32
26. Bensch, M., Schulze Wierling, P., von Lieres, E., Hubbuch J. (2005). High throughput screening of chromatographic phases for rapid process development. Chemical Engineering Technology 28,1274-1284
27. Thiemann, J., Jankowski, J., Rykl, J., Kurzawski, S., Pohl, T., Wittmann-Liebold, B., Schlüter, H. (2004). Principle and applications of the protein -purification-parame ter screening system. Journal of Chromatography A 1043,73-80
28. Rege, K., Pepsin, M., Falcon, B., Steele, L., Heng, M. (2006). High-throughput process development for recombinant protein purification. Biotechnology and Bio- engineering 93, 618-630
29. Booth, I, Coffman, J., Kelley, B. (2007). High throughput screening of protein A resin for purification process development. Presentation at the 234th ACS National Meeting, Boston, MA, 2007
30. Wenger, M.D., DePhillips, P., Price, C.E., Bracewell D.E. (2007). An automated microscale chromatographic purification of virus -like particles as a strategy for process development. Biotechnology and Applied Biochemistry 47,131-139
31. Micheletti,M., Lye, G. (2006). Microscale bioprocess optimization. Current Opinion in Biotechnology 17, 611-618
32. FDA (2004). PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. FDA, Rockville, MD
33. Rathore, A., Johnson, R., Yu, O., Kirdar, A., Annamalai, A., Ahuja, S., Ram, K. (2007). Applications of multivariate data analysis in biotech processing. BioPharm International 20,130-134
34. Kirdar, A., Conner, J., Baclaski, J., Rathore, A. (2007). Application of multi -variate analysis toward biotech processes: case study of a cell -culture unit operation. Bio technology Progress 23, 61-67
35. Velayudhan, A., Menon, M. (2007). Modeling of purification operations in biotech nology: Enabling process development, optimization and scale -up. Biotechnology Progress 23, 68-73
36. Low, D. (1986). The use of the FPLC system in method development and process monitoring for industrial protein chromatography. Journal of Chemical Technology and Biotechnology. 36, 345-350
37. Fahrner, R., Blank, G. (1999). Real-time monitoring of recombinant antibody breakthrough during Protein A affinity chromatography. Biotechnology and Applied Biochemistry 29,109-112
38. Cooley, R. (2003). U Michigan Pharmaceutical Education Seminar. http://www.fda. gov/cder/OPS/cooley/sld001.htm, accessed March 2003
39. Varghese, J. (2006). Comparison of analyzer technologies and viability for PAT applications. Presentation at the IBC 3rd International Conference Implementing Process Analytical Technologies (PAT) for Bioprocessing, Reston, VA, 2006
40. Bonam, D. (2005). Implementing PAT in biopharmaceutical processes: Issues and concerns. Presentation at the IFPAC Annual Meeting, Washington, DC, 2005
41. Rathore, A., Yu, M., Yeboah, S., Sharma, A. (2008). Case study and application of process analytical technology (PAT) towards BioProcessing: use of on-line high performance liquid chromatography for making real time pooling decisions for process chromatography. Biotechnology and Bioengineering 100, 306-316
42. Kozlowski, S. (2007). Role of QbD and PAT in biotechnology. Presentation at the IFPAC Annual Meeting, Washington, DC, 2007
43. Adamson, S.R. (2007). Role of technology and science in manufacturing economics . Presentation at the IBC Antibody Development and Production meeting, Carlsbad, CA, 2007
44. Farid, S.S., Washbrook, J., Titchener-Hooker, N.J. (2005). Decision-support tool for assessing bio -manufacturing strategies under uncertainty: Stainless steel versus disposable equipment for clinical trial material preparation. Biotechnology Prog ress 21,486-97
45. Sinclair, A., Monge, M. (2002). Quantitative economic evaluation of single use dis posables in bioprocessing. Pharmaceutical Engineering 22, 20-34
46. Langer, E.S., Ranck, J. (2005). The ROI case. Economic justification for disposables in biopharmaceutical manufacturing. BioProcess International 3 (October), 46-50
47. Farid, S.S., Washbrook, J.,Titchener-Hooker, N.J. (2005). Combining multiple quan titative and qualitative goals when assessing biomanufacturing strategies under uncertainty. Biotechnology Progress 21,1183-1191
48. Sinclair, A., Monge, M. (2005). Concept facility based on single -use systems. Bio- Process International 3 (suppl.), 51-55
49. Van Arnum, P. (2007) The changing fortunes of APIs. Pharmaceutical Technology, 1-6
50. Tempest, B. (2006). India: A global strategic asset for developed world market busi nesses. Journal of Generic Medicine 4, 37-2
51. Zhou, E.Y. (2007). China today: Biopharmaceutical industry trends in China- A five-year prospective. BioPharm International 20, 34-37
52. Jia, H. (2007). Chinese biotech hamstrung by production issues. Nature Biotechnol ogy 25,147-148
53. Basu, P. (2007). Indian biotech 's bumpy road. Nature 450, 580-581
54. Mazumdar-Shaw, K. (2006). Biocon's research initiatives and their global impact. The IVA Royal Technology Forum, October 26, 2006. Stockholm, Sweden
55. Kamarck, M.E. (2006). Building biomanufacturing capacity- The chapter and verse. Nature Biotechnology 24, 503-505
56. Kamarck, M.E., Hann, L.E., Adamson, S.R. (2007). Biotech manufacturing grows up. BioPharm International 20, 23-5
57. Frost & Sullivan (2005). Strategic Analysis of the World Biogenerics Market, 2005. Frost & Sullivan, London
58. Van Reis, R. (2006). Future trends in bioseparations. Presentation at the Recovery of Biological Products meeting, Litchfield Park, AZ, 2006
59. Vasserot, A., Dickinson, C., Tang, Y., Huse, W., Manchester, K., Watkins, J. (2003). Optimization of protein therapeutics by directed evolution. Drug Discovery Today 8,118-126
60. Myers, J. (2003). Improving antibody potency as a means to impact antibody pro duction. Presentation at the IBC Antibody Production and Downstream Process ing, La Jolla, CA, 2003
61. Hamilton, S., Bobrowicz, B., Davidson, R., Li, H., Mitchell, T., Nett, J., Rausch, S., Stadheim, T., Wischnewski, H., Wildt, S., Gerngross, T. (2003). Production of complex human glycoproteins in yeast. Science 301,1244-1246
62. Chadd, H., Chamow, S. (2001).Therapeutic antibody expression technology. Current Opinion in Biotechnology 12,188-194
63. Silverman, I, Lu, Q., Bakker, A., To, W., Duguay, A., Alba, B., Smith, R., Rivas, A., Li, P., Le, H., Whitehorn, E., Moore, K., Swimmer, C., Perlroth, V., Vogt, M., Kolkman, I, Stemmer, W.P. (2005). Multivalent avimer proteins evolved by exon shuffl ing of a family of human receptor domains. Nature Biotechnology 23,1556-1561