Analytical Best Practices

Aug 01, 2018
BioPharm International
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
Apr 17, 2018
By BioPharm International Editors
Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.
Mar 01, 2018
BioPharm International
Statistical methods to identify critical process parameters and critical material attributes—and approaches to control them—are needed to protect drug product and drug substances.
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.
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