BioPharm International-05-01-2018

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.

FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical 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.

While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.

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.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

CDMOs can claim credit for the robust growth of emerging bio/pharma financings.

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