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

19. Wang L, Hale G, Ghosh R. Non-size-based membrane chromatographic separation and analysis of monoclonal antibody aggregates. Anal Chem. 2006;78:6863–6867.

20. International Conference on Harmonization. Q1A(R2), Stability testing of new drug substances and products. Geneva, Switzerland;2003.

21. Philo JS. Is any measurement method optimal for all aggregate sizes and types? AAPS J. 2006;8(3):E564–E571.

22. Kiese S, Pappenberger A, Friess W, Mahler H-C. Shaken, not stirred: mechanical stress testing of an IgG1 antibody. J Pharm Sci. 2008;Oct;97(10):4347–66.

23. Mahler H-C. Break-out session on analytical methods. AAPS workshop on protein aggregation. 2006 Sep 26–27; Breckenridge, Colorado.

24. Lu Y, Harding SE, Rowe AJ, Davis KG, Fish B, Varley P, Gee C, Mulot S. The effect of a point mutation on the stability of IgG4 as monitored by analytical ultracentrifugation. J Pharm Sci. 2008;97(2):960–969.

25. Arakawa T, Kita Y. Protection of bovine serum albumin from aggregation by Tween 80. J Pharm Sci. 2000;89:646–651.

26. European Commission (Enterprise Directorate General). EMEA. Remicade Scientific Discussion. 2004.

27. Ives CM, Soderquist R, Stoner MR, Kendrick BS. Light obscuration particulate analysis for protein solutions: challenges and limitations. Colorado Protein Stability Conference. Poster presentation by Amgen. 2007.


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