Analytics

Feb 01, 2017
BioPharm International
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.
Feb 01, 2017
BioPharm International
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
Feb 01, 2017
BioPharm International
Despite limitations, mass spec is having an impact on biologic drug development and manufacturing.
Feb 01, 2017
BioPharm International
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
Jan 26, 2017
By BioPharm International Editors
PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.
Jan 01, 2017
BioPharm International
This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
Jan 01, 2017
BioPharm International
Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.
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.
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