Analytical Best Practices

Jul 01, 2016
BioPharm International
The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
Jun 01, 2016
BioPharm International
Specification limits should be set early in drug development and refined in later phases as data becomes available.
May 01, 2016
BioPharm International
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
Apr 01, 2016
BioPharm International
The author describes common components of a relative potency bioassay and provides a framework for assay development, calculation, and control.
Apr 01, 2016
BioPharm International
The authors investigate discrepancies in the reported efficacy of high-temperature short-time treatment for inactivating mouse minute virus.
Mar 21, 2016
A new study concluded although some mAb products have heterogeneous variants, these charge variants are associated with similar potency and pharmacodynamic profiles as originator molecules.
Mar 01, 2016
BioPharm International
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
Feb 09, 2016
Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.
Jan 01, 2016
BioPharm International
This article defines the concept, justification, and method of removal of out-of-trend points in stability modelling and shelf-life prediction.
Dec 09, 2015
Protea will use Agilent’s mass spectrometry imaging technology to develop new methods to identify cell metabolites produced as a result of disease or drug exposure.
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