Biopharmaceutical Analysis

Oct 01, 2013
BioPharm International
A well-designed comparability study can demonstrate the performance and advantages that can be gained when adopting a new protocol.
Sep 01, 2013
BioPharm International
Knowledge of product or process acceptance criterion is crucial in design space.
Sep 01, 2013
BioPharm International
Review the importance of characterization studies during biosimilars development and related analytical methods.
Sep 01, 2013
BioPharm International
A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
Aug 06, 2013
By BioPharm International Editors
A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
Aug 01, 2013
BioPharm International
Viruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.
Jul 01, 2013
BioPharm International
The author discusses the need for stability analysis.
Jun 01, 2013
BioPharm International
The authors provide common misconceptions and key concepts behind reliability engineering.
May 30, 2013
BioPharm International
By BioPharm International Editors
Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss new analytical testing procedures and instruments that are facilitating the testing processes or improving results.
May 30, 2013
BioPharm International
By BioPharm International Editors
Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss the key elements of an effective testing program to identify extractables from materials and leachables in drug products.
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