Analytical Methods

Sep 01, 2015
BioPharm International
Three case studies illustrate some analytical methods important for stability testing.
Aug 21, 2015
The rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.
Aug 01, 2015
BioPharm International
The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
Jul 24, 2015
By BioPharm International Editors
The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.
Jul 15, 2015
By BioPharm International Editors
The collaboration will address the need for novel analytical approaches for the characterization of glycans.
Jul 01, 2015
BioPharm International
Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.
Jul 01, 2015
BioPharm International
Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.
Jul 01, 2015
BioPharm International
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jun 01, 2015
BioPharm International
This article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.
May 01, 2015
BioPharm International
The rapid testing of biologic raw materials can lead to greater efficiency.
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