Articles by ProteinSimple - BioPharm International

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Articles by ProteinSimple

ProteinSimple


Articles
Simple and Sensitive Sub-visible Particle Classification for Biopharmaceuticals with Micro-Flow Imaging
June 24, 2014

Micro-Flow Imaging (MFI) provides accurate and sensitive detection of sub-visible particles and protein aggregates in biopharmaceuticals. Even better, MFI can classify particle populations. This application note takes you through how easy it is to develop custom particle filters to get more accurate and sensitive discrimination between the particles in your protein formulations.

Achieving 21 CFR Part 11 Compliance with the iCE3
March 25, 2014

Rapid analysis, platform methods, and easy method development make the iCE3 ideal for analyzing biologics. In fact, these benefits have made iCE? cIEF assays one of the key assays for biologics characterization and quality control. In this application note we review the iCE3 features that simplify system start up, operation, and compliance with 21 CFR Part 11.

Confirming Accurate Particle Counting and Sizing on MFI Systems
February 25, 2014

Micro-Flow Imaging (MFI) provides accurate and sensitive detection of sub-visible particles and protein aggregates in biopharmaceuticals. Confirmation of instrument performance is demonstrated using NIST-traceable polystyrene beads. This application note provides a guide to best practices for handling standards and samples to ensure sensitive, accurate, and repeatable results.

10 Minute Charge Heterogeneity Analysis
January 2, 2014

Platform methods, high resolution and ease of use have made the iCE system the gold standard for protein charge heterogeneity characterization for biopharmaceuticals. At 15-18 minutes per sample, iCE methods are already fast and simple but now they are even better. In this application note we describe a high throughput 10 minute charge heterogeneity analysis method and performance improvements that provide automated analysis of 100 samples at a time.

10-Minute Charge Heterogeneity Analysis
December 27, 2013

Platform methods, high resolution, and ease of use have made the iCE system the gold standard for protein charge heterogeneity characterization for biopharmaceuticals. At 15-18 minutes per sample, iCE methods are already fast and simple but now they are even better. In this application note we describe a high throughput 10-minute charge heterogeneity analysis method and performance improvements that provide automated analysis of 100 samples at a time.

MFI for Particle Characterization of Biopharmaceuticals Today
November 26, 2013

Micro-flow imaging (MFI) is a sensitive, simple and automated method for the routine analysis of sub-visible particles and translucent protein aggregates. This technology provides particle size, count and morphology. Morphology provides the ability to discriminate a wide variety of particle types allowing you to monitor the change in both protein aggregates and other particles over time. This article reviews the application of MFI for monitoring protein aggregates and sub-visible particles in biopharmaceuticals.

ProteinSimple - Comparability study of manual and automated particle characterization using MFI
September 24, 2013

Sub-visible particle analysis for biopharmaceuticals can now be automated with Micro-Flow Imaging ( MFI). MFI provides sensitive detection of translucent protein aggregates and other sub-visible particles. This case study from Takeda describes the transfer of a manual method to an automated format.

Development of Robust Charge Heterogeneity Assays using DOE
August 27, 2013

Develop robust charge heterogeneity assays using Design of Experiment (DOE). Utilizing imaged cIEF and DOE provides efficient and rapid method development and reduces assay failure. This application note provides a step-by-step process for the successful application of DOE tools with the iCE3.

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