Aggregation of Monoclonal Antibody Products: Formation and Removal - Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and

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Aggregation of Monoclonal Antibody Products: Formation and Removal
Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.


BioPharm International
Volume 26, Issue 3, pp. 40-45

REFERENCES

1. A.A. Shukla and J. Thommes, Trends in Biotechnology 28 (5), 253-261 (2010).

2. P.A.J. Rosa et al., J. Chromatogr. A 1217, 2296-2305 (2010).

3. A.A. Shukla et al., J. Chromatogr. B 848, 28-39 (2007).

4. The Development of Therapeutic Monoclonal Antibody Products, H. L. Levine and G. Jagschies, Eds. (BioProcess Technology Consultants Inc. and GE Healthcare, 2010).

5. S. Chen et al., Protein Sci. 19 (6), 1191-1204 (2010).

6. M.E. Cromwell, E. Hilario, and F. Jacobson, AAPS Journal 8 (3), E572-E579 (2006).

7. Y. B. Zhang et al., Protein Expr. Purif. 36 (2), 207-216 (2004).

8. D. Josic and Y.P. Lim Food Technol. Biotechnol. 39 (3), 215-226 (2001).

9. F. H. Liu, et al., mAbs 2 (5), 480-499 (2010).

10. FDA, Guidance for Industry: Q5A, Viral Safety Evaluation Of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. (Rockville, MD, 1998).

11. Q. Luo et al., J. Biol. Chem. 286 (28), 25134-25144 (2011).

12. R.H. Davis, Membrane Separations in Biotechnology. (Marcel Dekker Inc, New York, 2001) pp. 161–188.

13. A. Bodalo et al., Enzyme Microb. Technol. 35 (2-3), 261–266 (2004).

14. M. Meireles, P. Aimar, and V. Sanchez, Biotechnol. Bioeng. 38 (5), 528-34 (1991).

15. J.S. Bee et al., Biotechnol. Bioeng. 103 (5), 936–943 (2009).

16. M. K. Joubert et al., J. Biol. Chem. 286 (28), 25118-25133 (2011).

17. R.K. Brummitt et al., J. Pharm. Sci. 100 (6), 2087-2103 (2011).

18. S.B. Hari et al., J. Colloid. Interface. Sci. 196 (2), 170-176 (1997).

19. P. Arosio et al., Biophys. Chem. 168-169 19-27 (2012).

20. W. Norde and J. Lyklema, J. Colloid. Interface Sci. 66, 285 (1978).

21. A.W. Vermeer, M.G. Bremer, and W. Norde, Biochim. Biophys. Acta. 1425.(1),1-12 (1998).

22. K. A. Pikal-Cleland et al., Arch. Biochem. Biophys. 384 (2), 398-406 (2000).

23. G. Gómez, M. J. Pikal, and N. Rodriguez-Hornedo, Pharmaceutical Research 18 (1), 90-97 (2001).

24. L. A. Kueltzo et al., J. Pharm. Sci. 97 (5), 1801-1812 (2007).

25. A. Hawea et al., Eur. J. Pharm. Sci. 38, 79–87 (2009).

26. J.O. Wilkes, Fluid Mechanics for Chemical Engineers (Pearson Education Inc, Upper Saddle River, NJ, 2006).

27. J. X. Zhou et al., J. Chromatogr. A 1175 (1), 69-80 (2007).

28. J. Chen, J. Tetrault, and A. Ley, J. Chromatogr. A 1177 (2), 272-281 (2008).

29. P. Gagnon, "Purification of Monoclonal Antibodies by Mixed-Mode Chromatography," in Process Scale Purification of Antibodies, U. Gottschalk, Ed. (John Wiley and Sons, Hoboken, NJ, 2008), pp. 125-143.

30. P. Gagnon, Curr. Pharm. Biotechnol. 10, 434-439 (2009).

31. J.A. Asenjo and B.A. Andrews, J. Chromatogr. A 1218, 8826-8835 (2011).

32. I.F. Ferreira et al., J. Chromatogr. A 1195 (1-2), 94-100 (2008).

33. L. N. Mao et al., Biotechnol. Prog. 26 (6), 1662-1670 (2010).

34. P. A. J. Rosa et al, J. Chromatogr. A 1217 (16), 2296-2305 (2010).

35. N. Fraud et al., BioProcess Intl. 7 (s6), 30-35 (2009).


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