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.
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.
Nov 01, 2015
BioPharm International
The authors present a review of the techniques commonly used for glycosylation analysis.
Nov 01, 2015
BioPharm International
Whether taking an upstream, downstream or holistic approach, there are many factors to consider when choosing viral clearance methods.
Oct 01, 2015
BioPharm International
An approach to small-model generation and calibrating small-scale models to reliably predict performance at scale is presented.
Oct 01, 2015
BioPharm International
The author explores the basic rationale and requirements for standardized glycan analysis.
Sep 01, 2015
BioPharm International
Light-scattering techniques are useful for interaction studies when traditional methods of analysis do not suffice.
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