BioPharm International
March 01, 2018
Regulatory Beat
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Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
March 01, 2018
Perspectives on Outsourcing
31
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Development and adoption of new technologies create challenges that may take years to resolve.
March 01, 2018
Features
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Modeling at various stages of the data analytics continuum aids scale comparison of a bioreactor.
March 01, 2018
Ask the Expert
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In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
March 01, 2018
From the Editor
31
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FDA enforcement efforts and drug approvals trend upward.
March 01, 2018
Features
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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.
March 01, 2018
Features
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Alan Kennedy, executive director of TEAM UP, shared perspectives on Poseidon and ocean transport.
March 01, 2018
Analytical Best Practices
31
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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.
March 01, 2018
Features
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Spectroscopic tools present an alternative method for reliable at-line process monitoring and control.
March 01, 2018
Cover Story
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Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.
March 01, 2018
Issue PDF
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Click the title above to open the BioPharm International March 2018 issue in an interactive PDF format.