Analytical Best Practices - BioPharm International


Analytical Best Practices

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.

Moisture Matters in Lyophilized Drug Product

October 1, 2012

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

Compressing Drug Development Timelines with Accelerated Immunoassay

August 1, 2012

Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times.

Developing Alternatives to ELISA-Based Biomarker Assays

June 1, 2012

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



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