Whitepapers - BioPharm International

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Whitepapers

eBook: Troubleshooting Tips & Best Practices for Validation/Mapping

March 25, 2014

• Sensor placement: where, how many, and for how long? • Validation Master Plan checklist • Links to 1-hour webinars: Protocols, GAMP Guidance, and Regulations on Validation

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.

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.

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.

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.

TOYOPEARL GigaCap® DEAE-650M Preserving Resolution at Increased Protein Loads

April 30, 2013

TOYOPEARL GigaCap DEAE-650M, a very high capacity anion exchange resin for process scale chromatography, offers chromatographers a combination of binding capacities greater than 150 g/L while maintaining peak resolution.

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