Biopharmaceutical Analysis

Aug 17, 2016
By BioPharm International Editors
The Chinese facility was cited for data integrity violations.
Aug 01, 2016
BioPharm International
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
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.
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