March 2018
Volume 31, No. 3 |
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| COVER STORY |
Feliza Mirasol
Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.
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| PROCESS MODELING |
Lennart Eriksson, Chris McCready
Modeling at various stages of the data analytics continuum aids scale comparison of a bioreactor.
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| BioPharm International March Issue
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| DOWNSTREAM PROCESSING |
Feliza Mirasol
Spectroscopic tools present an alternative method for reliable at-line process monitoring and control.
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| PEER-REVIEWED |
Sara Kharazmi, Amin Baghizadeh, Masoud Torkzadeh-Mahani
The authors in this study developed an efficient bacterial expression system for large-scale production of soluble, homogenous extracellular binding domain of human TβRII (TβRII ECD) in three strains of Escherichia coli.
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| COLD-CHAIN DISTRIBUTION |
Agnes Shanley
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.
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| FROM THE EDITOR |
Rita C. Peters
FDA enforcement efforts and drug approvals trend upward.
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| REGULATORY BEAT |
Jill Wechsler
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
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| PERSPECTIVES ON OUTSOURCING |
Ronald A. Rader
Development and adoption of new technologies create challenges that may take years to resolve.
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| ANALYTICAL BEST PRACTICES |
Thomas A. Little, PhD
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.
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| ASK THE EXPERT |
Siegfried Schmitt
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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| EVENTS |
March 19–22, 2018
March 20–21, 2018
March 26–27, 2018
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