BioPharm International March 2018

March 2018 | Volume 31, Issue 3
BioPharm International March 2018 Issue
Issue PDF
By BioPharm International Editors
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Cover Story
Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.
Features
Modeling at various stages of the data analytics continuum aids scale comparison of a bioreactor.
Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.
Alan Kennedy, executive director of TEAM UP, shared perspectives on Poseidon and ocean transport.
Spectroscopic tools present an alternative method for reliable at-line process monitoring and control.
Regulatory Beat
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
Perspectives on Outsourcing
Development and adoption of new technologies create challenges that may take years to resolve.
Analytical Best Practices
Statistical methods to identify critical process parameters and critical material attributes—and approaches to control them—are needed to protect drug product and drug substances.
From the Editor
FDA enforcement efforts and drug approvals trend upward.
Ask the Expert
In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
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