Biopharmaceutical Analysis

Aug 01, 2016
BioPharm International
Multiple methods are required for detecting and removing protein impurities.
Aug 01, 2016
BioPharm International
Experts discuss recent advances in cell viability testing methods in bioreactors.
Jul 28, 2016
By BioPharm International Editors
NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.
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.
Jul 01, 2016
BioPharm International
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
Jun 20, 2016
The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.
Jun 01, 2016
BioPharm International
Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.
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
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.
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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