Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody Purification

September 1, 2009

A stable alternative to Protein A chromatography.

Use of Change-Point Analysis for Process Monitoring and Control

August 1, 2009

A better method for trend analysis than CUSUM and control charts.

Analytical Tools for Process and Product Characterization

August 1, 2009

Select the best approach to determine critical quality attributes.

QbD: Convincing the Skeptics

May 1, 2009

Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.

Monitoring of Biopharmaceutical Processes: Present and Future Approaches

May 1, 2009

This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.

Opalescence of an IgG1 MAb Formulation is Mediated by Ionic Strength and Excipients

April 1, 2009

Can increase in ionic strength result in higher viscosity?

Chromatography Optimization Strategy

March 1, 2009

Robust packing procedures can improve process performance and increase resin lifetime.

Considerations for Scaling-up Depth Filtration of Harvested Cell Culture Fluid

March 1, 2009

Data on the performance and variability of different formats.

QbD for Analytical Methods

February 1, 2009

QbD for QA? Try a two-step approach

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