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

ADVERTISEMENT

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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines
Source: BioPharm International,
Click here