Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe

Anacelia Ríos Quiroz; Jens Lamerz; Thierry Da Cunha; Adeline Boillon; Michael Adler; Christof Finkler; Joerg Huwyler; Roland Schmidt; Hanns-Christian Mahler; Atanas Koulov

doi:https://doi.org/10.1007/s11095-015-1801-4

doi.org/10.1007/s11095-015-1801-4

Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe

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..., Atanas Koulov

14

Pharmaceutical Research3.70

Volume: 33, Issue: 2, Pages: 450 - 461

Published: Oct 16, 2015

Abstract

Purpose The current study was performed to assess the precision of the principal subvisible particle measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical...

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Paper Details

Title

Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe

DOI

doi.org/10.1007/s11095-015-1801-4

Published Date

Oct 16, 2015

Journal

Pharmaceutical Research

Volume

33

Issue

2

Pages

450 - 461

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