Biopharmaceutical Analysis

Apr 12, 2017
By BioPharm International Editors
Endress+Hauser’s Memosens CPS171D pH electrode for hygienic and sterile biopharmaceutical processing provides stable measurements even after multiple cleaning and sterilization cycles.
Apr 01, 2017
BioPharm International
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
Apr 01, 2017
BioPharm International
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Apr 01, 2017
BioPharm International
FTIR can successfully measure key characteristics of therapeutic proteins in a single step.
Mar 09, 2017
By BioPharm International Editors
The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.
Mar 01, 2017
BioPharm International
Process characterization and model building are essential skills and are required for modern drug development.
Mar 01, 2017
BioPharm International
Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.
Mar 01, 2017
BioPharm International
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
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.
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