regulatory - Bioprocess Development Forum

Articles BioPharma

April 19, 2017

Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an...

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Articles Downstream Regulatory Upstream

May 25, 2016

Use of continuous cell lines in the manufacture of biological therapeutic products, such as...

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Articles Regulatory

April 8, 2015

As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable...

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Articles Downstream Regulatory Upstream

November 1, 2014

Removal and inactivation of adventitious and endogenous viruses have traditionally been achieved...

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Articles Downstream Regulatory Upstream

January 13, 2014

Cleaning validation plays an important role in reducing the possibility of product contamination...

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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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