ISPE & AAPS 2009 Coverage

 

News and multimedia coverage from this year's ISPE Meeting in San Diego, Calif. and AAPS Annual Meeting in Los Angeles, Calif.

Articles

Notes from ISPE: At Abbott, Leveraging PAT for the Entire API Life Cycle

Abbott has developed an entire lifecycle of API process understanding, but not without tremendous effort and coordination of formulation, development, and manufacturing teams.

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Amgen’s Low: PAT Addresses Bioprocess Complexity, Upstream and Down

At ISPE 2009, Amgen’s scientific executive director Duncan Low shared his company’s PAT successes, and aspirations.

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For QbD, the EU Shares the Burden

With no central regulatory authority such as the FDA, the EU has had to cobble together its own approach to regulating PAT/QbD-based drug applications. Regulatory authorities in the EU have developed a workable means of overseeing QbD work and, just as importantly, encouraging manufacturers to comfortably adopt QbD methods and principles, says J. Michael Morris, PhD, senior scientific advisor of the Irish Medicines Board.

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ISPE 2009: Successful Experiments (and Regulatory Reviews) in QbD

Citing examples, FDA’s Morefield emphasizes that drug development success (and regulatory favor) results from creative implementation of QbD principles.

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Notes from AAPS: Modeling’s Next Drug Development Challenge

It’s time for pharmacometricians and statisticians to leverage their expertise and break down drug development barriers.

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Videos

2011: Progress on the Pedigree Front?

Maxiom Group’s Scott Dicks answers our questions about whether drug manufacturers are moving ahead with electronic pedigree programs.

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PharmaView: Pharma Job Cuts: Decisive, Long-term Strategic Actions?

There’s no good way to deliver bad news, but that doesn’t mean it should be hidden or glossed over.

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From the Editor: Defining the Design Space

How can you talk your CEO into paying for Quality by Design if you can’t even agree on what its core concepts mean?

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Controlled Ice Nucleation Moves into Manufacturing

Two viable techniques exist for better lyo control in commercial processes, says UConn’s freeze-drying guru.

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Funny Pharm: You Write the Caption & Win: March 2011

Introducing "Funny Pharm," sponsored by Paratherm Corp., featuring drawings by award-winning cartoonist Jerry King. Submit your caption and win.

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Building a Modeling Culture in Manufacturing at Pfizer

At Pfizer, the value of models is not in mimicking reality, but in illustrating the interactions between people, equipment, materials, and time.

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Nestle: Curing People With Food

Nestle SA "pioneers a new industry between food and pharma."

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Light Induced Fluorescence as a “New” Tool for Pharmaceutical PAT

Light induced fluorescence can be considered a complementary tool in the pharmaceutical PAT toolbox.

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Podcasts

Podcast: QbD Software: Optimize Processes . . . and Thrill Executives

Design of Experiments software is being perfected for chromatography, dissolution, and tablet manufacturing, and as QbD goes “mainstream,” even pharmaceutical executives are shopping around for good software like this, says Graham Shelver of S-Matrix Corp. Shelver cautions that many software vendors will jump on the QbD bandwagon with products that have not proven themselves in pharmaceutical environments.

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