Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

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.

Product Characterization: A Primer

November 1, 2012

NIBRT's Jayne Telford provides an overview of biopharmaceutical analytics and their accompanying qualification and validation steps.

The Transformation to Process-Centered Organization

November 1, 2012

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

Moisture Matters in Lyophilized Drug Product

October 1, 2012

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

Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations

October 1, 2012

MIT survey results address product and site characteristics that statistically correlate with quality performance.

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.

Training the Biopharma Industry

September 1, 2012

Using a competency-based approach to effectively train biopharmaceutical industry staff.

A Method for Removal of Endotoxin from Pharmaceutical Formulation

September 1, 2012

The authors describe a simple method to remove endotoxins from highly viscous formulations.

Best Quality Practices for Biomedical R&D

August 1, 2012

Members from an ASQ working group provide analytical methods to enable PAT.

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