Analytical Methods

Dec 01, 2016
BioPharm International
Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.
Dec 01, 2016
BioPharm International
This report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.
Nov 01, 2016
BioPharm International
Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.
Nov 01, 2016
BioPharm International
The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.
Nov 01, 2016
BioPharm International
To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.
Oct 28, 2016
BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies about automating processes in upstream processing.
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.
native1_300x100
lorem ipsum