Whitepapers - BioPharm International

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Whitepapers

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.

Are “Canned” Performance Qualification Protocols Ok?

February 25, 2014

What’s the quickest solution to a robust PQ of your environmental monitoring system: DIY or vendor supplied? This article discusses the keys to evaluating “canned” PQ documents from suppliers and options for creating your own protocols. Also, is skipping the PQ process an option? Learn more…

Ligand Binding Analysis Using Surface Plasmon Resonance

February 25, 2014

When ligand binding is part of the functional activity of a biopharmaceutical, FDA and EMA guidelines require this property be quantified. The Biacore T200 provides real-time and label-free biomolecular interaction analysis and binding assays.

Charge Variant Analysis using pH Gradients

January 28, 2014

This Application Note shows method development for charge variant profiling of monoclonal antibodies using pH gradient elution with Agilent Buffer Advisor Software and online pH and conductivity monitoring.

How to Conduct Better Stability Studies with FDA/ICH Guidance

January 28, 2014

Download the new Application Note: “Better Stability Studies: Match Your Environmental Monitoring & Mapping to FDA/ICH Guidance.” Learn how to minimize the risk of incomplete data from result power or network failures during environmental mapping or monitoring applications and ensure stability study data complies with FDA/ICH guidance.

Hydrophobic Interaction Chromatography: Effects of Mixed Electrolytes on Protein Separations

January 28, 2014

For HIC separations, parameters other than resin surface modifications can be employed to enhance performance. This application note addresses the electrolyte composition of the mobile phase as one parameter responsible for protein adsorption and desorption. The results presented illustrate the benefits regarding capacity and selectivity in HIC of often neglected salts and their mixtures.

LC/MS Analysis of the Monoclonal Antibody Rituximab

January 28, 2014

In this Application Note, an Orbitrap-based mass spectrometer is used for high-confidence analysis of the intact and reduced forms of rituximab (monoclonal antibody), in biopharmaceutical product development and characterization.

Tosoh - Hydrophobic Interaction Chromatography: Effects of Mixed Electrolytes on Protein Separations

January 27, 2014

Tosoh - Hydrophobic Interaction Chromatography: Effects of Mixed Electrolytes on Protein Separations

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.

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