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Biotech R&D Demanding New Analytical Techniques, Technologies An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group Teva Changing Their Approaches With Quality by Design Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications Tech Transfer in the Age of QbD
 
Biotech R&D Demanding New Analytical Techniques, Technologies

Biotech R&D Demanding New Analytical Techniques, Technologies

Q&A with Dr E. Neil Lewis, Chief Technology Officer, Malvern Instruments

An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group

An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group

This discussion group activity provides the opportunity to get up to speed with the current status and future trends of analytical method qualification. Guest speaker will be: Dr. Phil Nethercote, Glaxo SmithKline Inc.  Read more...

Teva Changing Their Approaches With Quality by Design

Teva Changing Their Approaches With Quality by Design

Teva committed to QbD methodology implementation in late 2010. Inna Ben-Anat, QbD Strategy Leader, leads the ‎implementation at Teva's global generic R&D from Sellersville, Pennsylvania.

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

AskAboutValidation.com posted a really great Quality by Design overview piece in late 2012.

Tech Transfer in the Age of QbD

Tech Transfer in the Age of QbD

Arvindh Balakrishnan, Former VP of Life Sciences, Oracle and Russ Somma, President, SommaTech LLC discuss the components of characteristics of modern and effective technology transfer.

Reverse Quality by Design

09 April 2010

If you can design quality into a new product and make it better, why can't you use data to re-engineer a legacy product and continuously improve its quality?

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Bio QbD at Pfizer, Genentech: From Concept to Implementation

Bio QbD at Pfizer, Genentech: From Concept to Implementation

30 March 2010

Applying QbD to biopharmaceuticals can be more challenging than it is for small molecules. At BIO, experts from Genentech and Pfizer shared lessons they've learned so far in applying "Right First Time" to biopharm and in working on the FDA pilot program for biopharm QbD.

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Next Generation Nanosuspension Processing for the Delivery of Non-soluble Drugs

Next Generation Nanosuspension Processing for the Delivery of Non-soluble Drugs

30 March 2010

Roughly half of all new drugs in development are poorly soluble and often associated with low bioavailability. Among the most promising solutions to this challenge are nanosuspensions.

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Video: Ali Afnan of FDA on QbD and the Need for New Science and a Change in Mindset

30 March 2010

At a life sciences panel discussion during the 2009 Emerson Users Exchange, Ali Afnan, Senior Staff Fellow with the Office of Pharmaceutical Science, FDA's Center for Drug Evaluation and Research, discussed the issues slowing commercialization of drugs via QbD. It will take five to six years, he said, for drugs developed using a true QbD approach to reach the market.

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Bioprocess Control: What the Next 15 Years Will Bring

30 March 2010

Mammalian cell culture bioreactor processes are difficult to characterize and they demonstrate variability between batches. Without sufficient online detection and control, variations can lead to a high number of failed batches.

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Video: FDA’s Helen Winkle on Quality by Design and the Need to Prioritize Information

30 March 2010

At a panel discussion at Emerson's Users Exchange in September, Helen Winkle, Director of FDA's Office of Pharmaceutical Science at the Center for Drug Evaluation and Research, discussed the need for industry, and reviewers, to focus on information that is critical to product quality and safety.

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