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

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 t...

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Veröffentlicht in:European journal of pharmaceutical sciences 2014-03, Vol.53, p.95-108
Hauptverfasser: Werk, Tobias, Volkin, David B., Mahler, Hanns-Christian
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Sprache:eng
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