Pharmaceutical Technology, Sep 1, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Sep 1, 2008
Articles
Industrial Applications of Whole-Cell Biocatalysis
By Ulrich Becker , Kai Doderer , Steffen Osswald , Stefan Verseck , Wolfgang Wienand
Recombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.
High-Potency APIs: Containment and Handling Issues
By David Bormett
The author explains the planning, equipment, and facility design requried for manufacturing HPAPIs and specialized requirements for handling these compounds.
Highly Efficient Olefin-Metathesis Catalysts
By Xiaochong Bei , Daryl P. Allen , Richard L. Pederson, PhD
The authors describe the Piers' catalysts and detail latest progress in olefin-metathesis catalyst technology.
Manufacturing Considerations for Sourcing GMP Fermentation Services
By Sheryl Henderson , Steven McWethy , Keith Dixon
The authors describe the critical aspects of an ideal fermentation services provider.
Power Ultrasound and the Production of Mesoscopic Particles and Aqueous Dispersions
By Graham Ruecroft , Dipesh Parikh
The authors discuss advanced sonocrystallization particle-engineering techniques for manufacturing mesoscopic particles.
Epedigree in the Pharmaceutical Supply Chain
By Patricia Van Arnum
EPedigree, track-and-trace technologies, and other tools for optimizing supply-chain management are of increasing importance to the pharmaceutical industry. The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.
Expansion Activity of CMOs
By Patricia Van Arnum
The outlook is fairly optimistic as contract manufacturing organizations (CMOs) gather at CPhI Worldwide in Frankfurt. CMOs are expanding capacity for small-molecules, biologics, and finished-product manufacturing.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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Expedited reviews of drug submissions
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View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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