Analytical Methods

Oct 19, 2016
By BioPharm International Editors
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
Oct 15, 2016
BioPharm International
The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.
Sep 01, 2016
BioPharm International
Innovations in electrophoresis and chromatography upstream of protein characterization can accelerate research.
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 20, 2016
The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.
May 04, 2016
By BioPharm International Editors
Investment at SGS’s Mississauga, Canada facility provides for analysis of molecular interactions in real time.
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.
Mar 29, 2016
A $1.1-million NSF grant awarded to Advanced Polymer Monitoring Technologies will be used for the development of a characterization technology for monitoring aggregation in biopharmaceuticals.
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.
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