Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

Structural Characterization of Monoclonal Antibodies

August 2, 2011

The author describes techniques that can be used to provide the analytical data required by ICH Q6B for characterization of monoclonal antibodies.

Characterizing Biologics Using Dynamic Imaging Particle Analysis

August 2, 2011

Overcoming limitations of volumetric techniques and detecting transparent particles.

Efficient Multiproduct Process Development Case Study

August 1, 2011

Achieving multiproduct development within shortened timelines.

Systematic Approaches to Develop Chemically Defined Cell Culture Feed Media

November 1, 2010

Making chemically defined media work.

Technical and Economic Benefits of Membrane Chromatography During Polishing Steps

August 1, 2010

An analysis of flow rate, load density, viral clearance, and cost.

Mixed-Mode Chromatography in Downstream Process Development

March 2, 2010

Salt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins.

The Purification of Plasmid DNA for Clinical Trials Using Membrane Chromatography

February 1, 2010

Membrane chromatography ensures purity at high flow rates.

Statistical Equivalence Testing for Assessing Bench-Scale Cleanability

February 1, 2010

The two-one-sided t-test compares the equivalency of two data sets.

Salt Tolerant Interaction Chromatography for Large-Scale Polishing with Convective Media

October 2, 2009

STIC allows polishing to be carried out without an interstitial dilution step, which reduces process time and avoids additional buffer preparation and hold steps.

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