Regulatory - Bioprocess Development Forum

Articles Regulatory

August 13, 2015

Cleaning of pharmaceutical equipment is essential to reduce the risk of product contamination and...

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Articles Downstream Regulatory Upstream

June 4, 2015

Host-cell proteins (HCPs) constitute a major part of process-related impurities during biologics...

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Articles BioPharma Downstream Regulatory Upstream

April 8, 2015

Although continuous manufacturing is well established for bulk chemicals, complex automation and...

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Articles Regulatory

October 17, 2014

The quality-by-design principles that enable a manufacturer to limit and control the sources of process…

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Articles BioPharma Regulatory

October 1, 2014

Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers...

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Articles BioPharma Regulatory

July 18, 2014

A critical quality attribute (CQA) has been defined as “a physical, chemical, biological...

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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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Articles BioPharma Downstream Regulatory Upstream

July 5, 2013

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

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