The Coulter Principle for Analysis of Subvisible Particles in Protein Formulations
Journal Title: The AAPS Journal - Year 2011, Vol 13, Issue 1
Abstract
The Coulter principle can be used for analysis of subvisible particles in protein formulations. The approach has several advantages including: an orthogonal operating principle, high sensitivity, ability to detect very small particles, excellent reproducibility, and high-resolution size information. This minireview discusses some of the important considerations that must be taken into account when utilizing the Coulter principle for subvisible particle analysis in protein formulations.
Authors and Affiliations
Matthew N. Rhyner
Keywords
Related Articles
- EP ID EP681294
- DOI 10.1208/s12248-010-9245-6
- Views 85
- Downloads 0
Low molecular weight protamine (LMWP) as nontoxic heparin/low molecular weight heparin antidote (II): In vitro evaluation of efficacy and toxicity
Patients undergoing anticoagulation with heparin or low molecular weight heparin (LMWH) require a superior antidote that possesses more selective biological actions and a better safety profile than protamine. We had prev...
Gut Wall Metabolism. Application of Pre-Clinical Models for the Prediction of Human Drug Absorption and First-Pass Elimination
The online version of this article (doi:10.1208/s12248-016-9889-y) contains supplementary material, which is available to authorized users.
Biomarker qualification pilot process at the US Food and Drug Administration
New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consen...
Mucoadhesive Microspheres for Gastroretentive Delivery of Acyclovir: In Vitro and In Vivo Evaluation
The aim of the present investigation was to evaluate the potential use of mucoadhesive microspheres for gastroretentive delivery of acyclovir. Chitosan, thiolated chitosan, Carbopol 71G and Methocel K15M were used as muc...
Computational methods in drug design: Modeling G protein-coupled receptor monomers, dimers, and oligomers
G protein-coupled receptors (GPCRs) are membrane proteins that serve as very important links through which cellular signal transduction mechanisms are activated. Many vital physiological events such as sensory perception...