Analytics

Aug 14, 2017
By BioPharm International Editors
The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.
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 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.
Jul 01, 2017
BioPharm International
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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