Analytical Best Practices

Oct 24, 2017
This article examines how process characterization is crucial to process understanding and then applying that understanding to controlling a process.
Apr 01, 2017
BioPharm International
FTIR can successfully measure key characteristics of therapeutic proteins in a single step.
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
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
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
Oct 01, 2016
BioPharm International
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
Aug 01, 2016
BioPharm International
Experts discuss recent advances in cell viability testing methods in bioreactors.
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 01, 2016
BioPharm International
Specification limits should be set early in drug development and refined in later phases as data becomes available.
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.
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