Analytics

Feb 02, 2007
BioPharm International
By BioPharm International Editors
This article discusses how on-line high-performance liquid chromatography (HPLC) can measure product purity in the column eluent stream in near–real time. These data can then enable the automation and control of a purification column operation, thus reducing product variability, shortening process cycle time, and increasing yield. An example application demonstrates how on-line HPLC is used as a process analytical technology to ensure the process can accommodate variability in the separation while ensuring the product meets its critical quality attributes.
Feb 02, 2007
BioPharm International
These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.
Dec 01, 2006
BioPharm International
Conducting an analysis of the 4 Ms—man, machine, methods, and materials—enables companies to identify the true root causes of deviations.
Nov 01, 2006
BioPharm International
By BioPharm International Editors
Increased resin stability can extend the number of cleaning cycles that can be performed in situ.
Oct 01, 2006
BioPharm International
The first part of this article, published in the September 2006 issue, discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.
Sep 27, 2006
BioPharm International
By BioPharm International Editors
PerkinElmer Inc. (Wellesley, MA, www.perkinelmer.com) has acquired Avalon Instruments Limited (Belfast, Northern Ireland).
Sep 02, 2006
BioPharm International
By BioPharm International Editors
Reserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.
Sep 02, 2006
BioPharm International
By BioPharm International Editors
SOPs are written job aids that detail the procedure of how to do a specific job task correctly.
Sep 01, 2006
BioPharm International
Good risk management tools dictate how much assay performance characteristics can deviate from ideal.
Aug 02, 2006
BioPharm International
By BioPharm International Editors
Nothing beats a good dictionary. It can clarify doubts, settle an argument, or prompt exploration into new areas of learning.
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