Pharmaceutical Technology, Feb 1, 2014 - Pharmaceutical Technology

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Pharmaceutical Technology, Feb 1, 2014
Featured Content
Outsourcing Trends in Biopharmaceutical Manufacturing
By Eric Langer
A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.
A New Dawn for Western CMOs
By Andreas Weiler
Increased competition from CMOs in Asia means that Western CMOs need to understand fundamental changes in the market.
Partnership Models Structure R&D Change
By Benjamin K. Gill , Jim Prutow
Pharmaceutical companies are adopting multiple choice partnership strategies to meet the challenges of today's R&D instead of being focused primarily on internal development.
Managing Clinical Development Risk: Pharma and CRO Report
By Denise Calaprice-Whitty , Janis Hall
The relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
By Clinton Weber , Ashok Kumar , Lisa Joslin , Roland Ashton , James Schmid , Michael Larson
Traditional project decision-making is compared with a QbD approach.
Global Markets Demand Local Knowledge
Contract manufacturing organizations that are established in key markets can provide a competitive edge.
Clinical-Trial Material Supply by Way of Shanghai
Geographic location, customs and drug-development regulations knowledge, and transportation infrastructure were factors in Catalent Pharma Solutions' selection of Shanghai for its clinical-trials supply facility.
Ensuring Sound Bioanalytical Methods Transfer
For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.

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Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
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Regulatory compliance
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Obtaining/maintaining adequate financing
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View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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