BioPharm International May 2017

May 2017 | Volume 30, Issue 5
BioPharm International May 2017 issue
Cover Story
Can bioprocessing runs be consistently replicated in an inherently variable production environment?
Downstream Processing
Continuous downstream bioprocessing is proving its worth, but connecting different operations and integrating upstream remains a challenge.
Features
The existing, obsolete high purity water generation system and water-for-injection generation system were replaced with new, reliable technologies.
Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
Improving the bioreactor growth environment increases the rigor of bioprocessing runs.
Peer-Reviewed Research
This article provides an overview on important aspects related to bracketing strategies in Japan.
Regulatory Beat
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Perspectives on Outsourcing
CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
Ask the Expert
By BioPharm International Editors
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
From the Editor
New study will reveal bio/pharma practices and performance on quality issues.
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