Case Study: Retrofitting Two New High Purity Water Systems
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.
Enhancing Bioprocessing Efficiencies through Run Reproducibility
Can bioprocessing runs be consistently replicated in an inherently variable production environment?
Robots Package Parenteral Products
Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.
Keeping an Eye on Quality
New study will reveal bio/pharma practices and performance on quality issues.
Combination Products Raise New Manufacturing Challenges
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
Continuous Bioseparations: Fitting the Pieces Together
Continuous downstream bioprocessing is proving its worth, but connecting different operations and integrating upstream remains a challenge.
Engaging with Interest Groups or Industry Associations
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
CMOs and CROs Have Different Trajectories
CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
New Directions in Bioreactor Design
Improving the bioreactor growth environment increases the rigor of bioprocessing runs.
Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process
This article provides an overview on important aspects related to bracketing strategies in Japan.
BioPharm International, May 2017 Issue (PDF)
Click the title above to open the BioPharm International May 2017 issue in an interactive PDF format.
