Analytics

Aug 01, 2017
BioPharm International
The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.
Aug 01, 2017
BioPharm International
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Aug 01, 2017
BioPharm International
Amid debate about “fake news,” peer-review papers offer vital, objective insight.
Jul 05, 2017
By BioPharm International Editors
A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.
Jul 05, 2017
By BioPharm International Editors
A new probe developed by researchers at the University of Melbourne, Australia, would allow NMR to be used without the use of microwaves, and with smaller machines.
Jul 05, 2017
By BioPharm International Editors
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
Jul 01, 2017
BioPharm International
Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.
Jul 01, 2017
BioPharm International
Optimize practices and meet requirements using electronic data integrity systems.  
Jul 01, 2017
BioPharm International
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
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.
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