Articles - Bioprocess Development Forum

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January 11, 2014

Once risk levels have been assigned to the CQAs, the next activity is to begin…

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Articles BioPharma Regulatory

December 29, 2013

Quality by Design (QbD) is a concept applied to the design and development...

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Articles Downstream

November 22, 2013

BioPharm InternationalBy: Anurag S. Rathore, Ranga Godavarti, Vijesh Kumar, Nihal Tugcu for BioPharm International The…

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October 4, 2013

Design-space generation always begins with CQAs, risk assessments, definition of materials...

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August 23, 2013

Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1),…

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Articles BioPharma Downstream Upstream

August 5, 2013

To gain perspective on the implementation of quality by design (QbD) and process analytical...

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Articles BioPharma Downstream Regulatory Upstream

July 5, 2013

In recent years, most pharmaceutical companies have focused on the development of...

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Articles

June 22, 2013

From a CMO perspective, the traditional strategy behind process development has largely been to...

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