Analytical Best Practices - BioPharm International

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Analytical Best Practices

Design of Experiments for Analytical Method Development and Validation

March 1, 2014

Design of experiment is a powerful development tool for method characterization and method validation.

Understanding and Modeling Product and Process Variation

December 1, 2013

Variation understanding and modeling is a core component of modern drug development.

Performing a Protein Purity Analysis Comparability Study

October 1, 2013

A well-designed comparability study can demonstrate the performance and advantages that can be gained when adopting a new protocol.

Essentials in Establishing and Using Design Space

September 1, 2013

Knowledge of product or process acceptance criterion is crucial in design space.

Essentials in Stability Analysis and Expiry Determination

July 1, 2013

The author discusses the need for stability analysis.

Essentials in Quality Risk Management

May 1, 2013

Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.

Bioanalytical Methods for Sample Cleanup

December 1, 2012

Preparation of biological samples for chromatographic analyses.

Assay Development and Method Validation Essentials

November 1, 2012

A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.

Meeting Challenges for Analysis of Antibody-Drug Conjugates

October 1, 2012

The complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.

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