Search results for " CQA"

Article Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes. By Cynthia A. Challener Biopharmaceutical manufacturing involves a series o…

Article Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…

Article A Bright Future for the Plasma Fractionation Industry
There is still a very bright future for the plasma fractionation industry. That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful isla…

Article Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials. It would seem that raw materials used in bioprocessing operations are a relatively straig…

Article Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles. The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…

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