BioPharm International-05-01-2017

a capital investment project was required to replace the existing, obsolete high purity water (HPW) generation system and water-for-injection (WFI) generation system with new, reliable technology.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

New study will reveal bio/pharma practices and performance on quality issues.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

Continuous downstream bioprocessing is proving its worth, but connecting different operations and integrating upstream remains a challenge.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.

CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.

Improving the bioreactor growth environment increases the rigor of bioprocessing runs.

This article provides an overview on important aspects related to bracketing strategies in Japan.

Click the title above to open the BioPharm International May 2017 issue in an interactive PDF format.