Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

Performing Hydrogen/Deuterium Exchange with Mass Spectrometry

August 1, 2012

In HDX studies, data are produced across multiple time points, multiple species, and with replicates.

Nuclear Magnetic Resonance as a Bioprocessing QbD Application

August 1, 2012

Current expectations in bioprocessing and a framework for using NMR to enhance a QbD approach.

Tools for Enabling Process Analytical Technology Applications in Biotechnology

August 1, 2012

The authors review the various analytical methods that can enable use of PAT.

Reduce Analytical Testing and Costs Without Compromising Compliance

July 1, 2012

Unnecessary analytical testing can lead to unnecessary costs.

A New Era in Cell Culture Media Development

July 1, 2012

Cell-line specific complex media supplements combine chemically defined media additives into a single supplement.

Developing Alternatives to ELISA-Based Biomarker Assays

June 1, 2012

The authors discuss a new, rapid immunoassay for the detection of biomarkers.

A New Way to Think About Outsourcing Partnerships

May 1, 2012

Future sponsor-contract provider relationships will require more integration.

The Growing Orphan-Drug Paradigm

April 1, 2012

Rather than seeking a single indication for one large group, the orphan-drug approach segments the market for a drug more minutely.

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.

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