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

1. Dresser DW. Specific inhibition of antibody production: II. Paralysis induced in adult mice by small quantities of protein antigen. Immunol. 1962;5(3):378–388.

2. Braun A, Kwee L, Labow MA, Alsenz J. Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha in normal and transgenic mice. Pharm Res. 1997;14(10):1472–1478.

3. Moore WV, Leppert P. Role of aggregated human growth hormone (hGH) in development of antibodies to hGH. J Clin Endocrinol Metab. 1980;51:691–697.

4. Prümmer O. Treatment-induced antibodies to interleukin-2. Biotherapy. 1997;10(1):15–24.

5. Dintzis RZ, Okajima M, Middleton MH, Greene G, Dintzis HM. The immunogenicity of soluble haptenated polymers is determined by molecular mass and hapten valence. J Immun. 1989;143(4):1239–1244.

6. Bachmann M, Zinkernagel R. Neutralizing antiviral B-cell responses. Annu Rev Immunol. 1997;15:235–270.

7. Rosenberg A. Effects of protein aggregates: an immunological perspective. AAPS J. 2006;8(3):E501–E507.

8. Lumry R, Eyring H. Conformation changes of proteins. J Phys Chem. 1954;58:110–120.

9. Kendrick BS, Carpenter JF, Cleland JL, Randolph TW. A transient expansion of the native state precedes aggregation of recombinant human interferon-g. Proc Natl Acad Sci USA. 1998;95:14142–14146.

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.

17. Carpenter JF, Nikolai T. Pumping-induced aggregation of monoclonal antibodies. AAPS Workshop on protein aggregation, Oral presentation. Breckenridge, CO. 2006 Sep.

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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