BioPharm International May 2018

May 2018 | Volume 31, Issue 5
BioPharm International May 2018 Issue
Cover Story
More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.
Features
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and systems.
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and downstream applications.
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
Peer-Reviewed Research
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.
Regulatory Beat
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
Perspectives on Outsourcing
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
From the Editor
While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.
Ask the Expert
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
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