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      Effect of solution properties on the counting and sizing of subvisible particle standards as measured by light obscuration and digital imaging methods.

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          Abstract

          Protein formulations may contain subvisible particle (SbVP) impurities that can vary (e.g., in number, size, shape, density, refractive index and transparency) depending on the formulation composition, environmental stresses and the type of protein. Additionally formulation solutions may differ in their physical properties including turbidity, color, viscosity, density and refractive index. This study examined the impact of these formulation matrix parameters on the ability to size and count subvisible particles using a variety of analytical methods including two light obscuration (HIAC, Syringe) and two digital imaging instruments (MFI®, FlowCAM®). Several subvisible particle standards were tested, including polystyrene and glass beads as well as a new pseudo-protein particle standard, in order to also study of the effect of subvisible particles with different properties.

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          Author and article information

          Journal
          Eur J Pharm Sci
          European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
          Elsevier BV
          1879-0720
          0928-0987
          Mar 12 2014
          : 53
          Affiliations
          [1 ] Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland. Electronic address: tobias.werk@roche.com.
          [2 ] Department of Pharmaceutical Chemistry, Macromolecule and Vaccine Stabilization Center, University of Kansas, Lawrence, Kansas 66047, USA.
          [3 ] Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
          Article
          S0928-0987(13)00484-3
          10.1016/j.ejps.2013.12.014
          24370624
          46cb45f8-b942-4dd7-a3f6-caaf85b2a920
          History

          Turbidity,Coloration,Flow imaging,Light obscuration,Viscosity

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