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J Pharm Sci. 2012 Mar;101(3):914-35. doi: 10.1002/jps.23001. Epub 2011 Dec 8.

Particles in therapeutic protein formulations, Part 1: overview of analytical methods.

Author information

1
Coriolis Pharma, Am Klopferspitz 19, 82152 Martinsried-Munich, Germany.

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.

PMID:
22161573
DOI:
10.1002/jps.23001
[Indexed for MEDLINE]

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