Analytics

Apr 25, 2016
By BioPharm International Editors
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
Apr 18, 2016
By BioPharm International Editors
The agency published guidance on data integrity as it is relates to CGMP compliance.
Apr 02, 2016
BioPharm International
Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.
Apr 01, 2016
BioPharm International
The authors provide application data to support the use of SEC beyond small-scale operations.
Apr 01, 2016
BioPharm International
The author describes common components of a relative potency bioassay and provides a framework for assay development, calculation, and control.
Mar 22, 2016
The ready-to-use assays are specifically designed for companies looking to characterize their biosimilar products in the pipeline.
Mar 21, 2016
A new study concluded although some mAb products have heterogeneous variants, these charge variants are associated with similar potency and pharmacodynamic profiles as originator molecules.
Mar 01, 2016
BioPharm International
Collaborative efforts are underway between suppliers and drug manufacturers to address raw material variability.
Mar 01, 2016
BioPharm International
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
Feb 09, 2016
Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.
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