Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory Perspective - FDA perspectives on specifications and effective control strategies - BioPharm International

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Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory Perspective
FDA perspectives on specifications and effective control strategies


BioPharm International
Volume 21, Issue 11

Ruth V. Cordoba-Rodriguez, PhD, is a biologist in the division of monoclonal antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, 301.827.0454,
.

REFERENCES

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10. Chaderjian WB, Chin ET, Harris RJ, Etcheverry TM. Effect of copper sulfate on performance of a serum-free CHO cell culture process and the level of free thiol in the recombinant antibody expressed. Biotech. Prog. 2005;21:550–553.

11. Remmele JR. RL, Callahan WJ, Krishnan S, Zhou L, Bondarenko PV, Nichols AC, et al. Active dimer of epratuzumab provides insight into the complex nature of antibody aggregate. J Pharm Sci. 2006;95(1):126–145.

12. Kendrick BS, Chang BS, Arakawa T, Peterson B, Randolph TW, Manning MC, Carpenter JF. Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: Role in restricted conformational mobility and compaction of native state. Proc Natl Acad Sci USA. 1997;94:11917–11922.

13. Andya JD, Hsu CC, Shire SJ. Mechanisms of aggregate formation and carbohydrate excipient stabilization of lyophilized humanized monoclonal antibody formulations. AAPS J. 2003;5(2):1–11

14. Webb SD, Sesin DF, Kincaid AC, Webb JN, Hughs TG. Freezing bulk-scale biopharmaceuticals using common techniques and the magnitude of freeze concentration. BioPharm Int. 2002;5:22–34.

15. Pikal-Cleland KA, Carpenter JF. Lyophilization-induced protein denaturation in phosphate buffer systems: monomeric and tetrameric b‚ galactoside. J Pharm Sci. 2001;90(9):1255–1268.

16. Cromwell MEM, Hilario E, Jacobson F. Protein aggregation and bioprocessing. AAPS J. 2006;8(3):E572–E579.

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18. Narhi L. Effects of manufacturing processes on a therapeutic protein. AAPS Workshop on protein aggregation, Oral presentation. Breckenridge, CO. 2006 Sep.


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