Analytical Methods

Aug 01, 2017
BioPharm International
Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.
Jul 01, 2017
BioPharm International
While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.
Jun 01, 2017
BioPharm International
How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
May 01, 2017
BioPharm International
This article provides an overview on important aspects related to bracketing strategies in Japan.
Apr 01, 2017
BioPharm International
FTIR can successfully measure key characteristics of therapeutic proteins in a single step.
Apr 01, 2017
BioPharm International
Chromatography modeling can enhance bioprocessing efficiencies.
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
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.
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