Analytical Tools for Process and Product Characterization - Select the best approach to determine critical quality attributes. - BioPharm International


Analytical Tools for Process and Product Characterization
Select the best approach to determine critical quality attributes.

BioPharm International
Volume 22, Issue 8


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22. Gabrielson JP, et al. Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity. J Pharm Sci. 2007;96(2):268–79.

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

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31. Samavedam R, Morrison R, Kichefski T, Cote S, Rathore AS. Lifetime studies for membrane reuse: principles and case study. BioPharm Int. 2007;20(9):48–54.

32. Rathore AS, Sofer GS. Lifespan studies for chromatography and filtration media. In: Rathore AS, Sofer GS, editors. Process Validation. Marcel Dekker; 2005. p. 169–203.

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