Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2485982 | Journal of Pharmaceutical Sciences | 2012 | 22 Pages |
Abstract
The presence of particles is a major issue during therapeutic protein formulation development. Both proteinaceous and nonproteinaceous particles need to be analyzed not only due to the requirements of the Pharmacopeias but also to monitor the stability of the protein formulation. Increasing concerns about the immunogenic potential together with new developments in particle analysis make a comparative description of established and novel analytical methods useful. Our review aims to provide a comprehensive overview on analytical methods for the detection and characterization of visible and subvisible particles in therapeutic protein formulations. We describe the underlying theory, benefits, shortcomings, and illustrative examples for quantification techniques, as well as characterization techniques for particle shape, morphology, structure, and identity.
Keywords
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
Sarah Zölls, Ruedeeporn Tantipolphan, Michael Wiggenhorn, Gerhard Winter, Wim Jiskoot, Wolfgang Friess, Andrea Hawe,