Drug Substance Analysis

Jul 19, 2018
By BioPharm International Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jun 01, 2018
BioPharm International
Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
Jan 01, 2018
BioPharm International
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
Sep 15, 2017
BioPharm International
A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.
Jun 01, 2017
BioPharm International
An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.
Jun 01, 2017
BioPharm International
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
Jun 01, 2017
BioPharm International
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
Apr 01, 2017
BioPharm International
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
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.
Jan 01, 2017
BioPharm International
This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
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