September 2016
Volume 28, No. 9 |
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SUPPLIER QUALITY
Agnes Shanley
Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home.
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API SYNTHESIS & MANUFACTURING
Cynthia A. Challener
Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.
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PARENTERAL MANUFACTURING
Agnes Shanley
The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
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PharmTech Europe September Issue
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FORMULATION
Melina Figueiredo, Diana M. Leite, Aikaterini Lalatsa
Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier. / read more /
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VISUAL INSPECTION TECHNIQUES
Gretchen L. Shearer, PhD
Visual inspection of parenteral vials is the first step in a root cause investigation.
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MANUFACTURING AUTOMATION
Jennifer Markarian
In the pharmaceutical factory of the future, data collected by internet-connected manufacturing equipment improves operational efficiency.
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FACILITY RENOVATION
Eric Bohn
Renovating a facility requires careful design and a plan to minimize production interruption.
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MODULAR MANUFACTURING
Caroline Hroncich
Industry experts discuss recent trends in modular manufacturing.
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PEER-REVIEWED RESEARCH
Richard J. Forsyth
Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.
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ASEPTIC MANUFACTURING
Fintan Weston
While isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.
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OUTSOURCING REVIEW
Jim Miller
The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
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TROUBLESHOOTING
Paul McClune
A process-specific preventative maintenance program improves productivity and reliability.
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ASK THE EXPERT
Siegfried Schmitt
Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.
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REGULATORY WATCH
Sean Milmo
The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.
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FROM THE EDITOR
Adeline Siew, PhD
Pricing of a lifesaving allergy treatment raises concerns.
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PRODUCT SPOTLIGHT
Tumble Blenders from Ross, Charles & Son now come standard with motors equipped with a electro-magnetic brake.
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The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems.
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The OM-CP-CRYO-TEMP ultra-low temperature data logger from Omega Engineering records temperatures as low as -86 °C.
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The FlowCam ALH automated liquid handling system from Fluid Imaging Technologies is a particle imaging and analysis system that automatically detects, images, and characterizes individual particles and microorganisms.
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Events
28-29 September, 2016 | London, England
4-6 October, 2016 | Barcelona, Spain
25-26 October, 2016 | Berlin, Germany
more events
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