BioPharm International October 2017

October 2017 | Volume 30, Issue 10
BioPharm International October 2017 Issue
Cover Story
There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.
Features
Manufacturers introduce innovations in glass and plastic packaging for injectables.
Detecting viral contaminants in biologic-based medicines—and identifying their source—requires a holistic testing approach.
A UHPLC SEC approach for protein aggregate analysis of mAbs is presented.
Peer-Reviewed Research
This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.
Regulatory Beat
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Perspectives on Outsourcing
Mergers and acquisitions are positive for the CDMO industry, but there is a downside.
Downstream Processing
This study outlines methods for an alternative protein-polishing process for challenging proteins.
Manufacturing
Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.
Ask the Expert
Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
From the Editor
Reeling from financial and tropical storms, Puerto Rico needs stable industry to aid its recovery.
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