Analytical Method Development

Jun 15, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.
May 18, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
Recent recalls, including that of American Regent?s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.
May 01, 2011
Pharmaceutical Technology
The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.
Feb 02, 2011
Pharmaceutical Technology
A roundtable moderated by Angie Drakulich.
Nov 02, 2010
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author examines the process of method development, with reference to ISO 13320:2009 and relevant monographs from the United States and European pharmacopoeias.
Aug 02, 2010
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.
May 02, 2010
Pharmaceutical Technology
A method for determining sample size is finally getting some respect.
Apr 02, 2010
Pharmaceutical Technology
The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.
Apr 01, 2010
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain — traditionally produced vaccines take approximately 6 months.
Mar 30, 2010
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
A novel approach for assessing method robustness is described that uses risk-based assessment tools to identify, score, prioritise and then group method parameters.
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