title: Particles in therapeutic protein formulations, Part 1: overview of analytical methods.
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.
authors.affiliation: Coriolis Pharma, Am Klopferspitz 19, 82152 Martinsried-Munich, Germany.
authors.forename: Sarah
authors.initials: S
authors.lastname: Zölls
authors.forename: Ruedeeporn
authors.initials: R
authors.lastname: Tantipolphan
authors.forename: Michael
authors.initials: M
authors.lastname: Wiggenhorn
authors.forename: Gerhard
authors.initials: G
authors.lastname: Winter
authors.forename: Wim
authors.initials: W
authors.lastname: Jiskoot
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Friess
authors.forename: Andrea
authors.initials: A
authors.lastname: Hawe
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000737:chemistry; D055550:Protein Stability; D011506:Proteins / Q000737:chemistry*
chemical_list: D004364:Pharmaceutical Preparations; D011506:Proteins