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

Robustness of ionKey/MS System in the Analysis of Pharmaceutical Compounds in Biological Fluids

March 25, 2014

The robustness and reliability of pharmacokinetic (PK) data is an essential part of bioanalysis. LC-MS is the technique of choice in quantitative bioanalysis due to the high selectivity and sensitivity the technique offers.

TOYOPEARL AF-rProtein A HC-650F Host Cell Protein Removal

March 25, 2014

The following paper compares the host cell protein (HCP) removal capabilities of TOYOPEARL AF-rProtein A HC-650F, TOYOPEARL AF-rProtein A-650F, and another commercially available high-capacity protein A resin.

Industry Report on Viral Destruction: Smooth thermal processes consistently and effectively destroy these germs

March 25, 2014

This Q&A report includes information on viral inactivation and sterilization, integration, scale up, and advantages of high temperature short-time (HTST) and ultra-high temperature (UHT) processes.

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.

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.

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.

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.

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