References
1. Cordoba-Rodriguez RV. Aggregates in MAbs and recombinant therapeutic proteins: a regulatory perspective. BioPharm Int
2008;21(11):44–53.
2. Fahrner RL, Knudsen HL, Basey CD, Galan W, Feuerhelm D, Vanderlaan M, et al. Industrial purification of pharmaceutical
antibodies: development, operation, and validation of chromatography processes. Biotechnol Genet Eng Rev. 2001;18:301–27.
3. Kelley B. Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol Progr.
2007;23(5):995–1008.
4. Walsh G. Biopharmaceutical benchmarks 2006. Nat Biotechnol. 2006;24(7):769–76.
5. Low D, O'Leary R. Pujar NS. Future of antibody purification. J Chrom B, 2007;848(1):48–63.
6. Farid, S. Process economic drivers in industrial monoclonal antibody manufacture. In: Gottschalk U, editor. Process scale
purification of antibodies. Hoboken, NJ: John Wiley & Sons; 2009. p. 239–62.
7. Zhou JX, Tressel T. Basic concepts in Q membrane chromatography for large-scale antibody production. Biotechnol Prog.
2006;22(2):341–9.
8. Boi C. Membrane adsorbers as purification tools for monoclonal antibody purification. J Chrom B. 2007;848(1):19–27.
9. Gottschlich N, Kasche V. Purification of monoclonal antibodies by simulated moving-bed chromatography. J Chrom A. 1997;765(2):201–6.
10. Strohlein G, Aumann L, Muller-Spath T. Morbidelli M. The multicolumn countercurrent solvent fradient purification process.
BioPharm Int. 2007 Feb supplement, Advances in Process Chromatography;42–8.
11. Muller-Spath T, Aumann L, Strohlein G. Chromatographic separation of three monoclonal antibody variants using multicolumn
countercurrent solvent gradient purification (MCSGP). Biotechnol Bioeng. 2008;100(6):1166–77.
12. Przybycien TM, Pujar NS, Steele LM. Alternative bioseparation operations: life beyond packed-bed chromatography. Curr
Opin Biotech. 2004;15(5):469–78.
13. McDonald P, Victa C, Carter-Franklin JN, Fahrner R. Selective antibody precipitation using polyelectrolytes: A novel
approach to the purification of monoclonal antibodies Biotech Bioeng. 2009;102(4):1141–51.
14. Giese, G. Polyethylene glycol precipitation of monoclonal antibodies and the impact on column chromatography. Presented
at BioProcess International Conference 2009.
15. Glynn, J. Process-scale precipitation of impurities in mammalian cell culture broth. In: Gottschalk U, editor. Process
scale purification of antibodies. Hoboken, NJ: John Wiley & Sons; 2009. p. 309–24.
16. Wang J, Diehl T, Aguiar D, Dai XP, Arunakumari A. BioPharm Int. 2009 Jan Supplement, Vaccine Development and Manufacturing:
Pandemics and Beyond;22(10):4–10.
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