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Applying Quality By Design Methods To Chromatography
By Dr. Jonas Anders, Merck Millipore
Quality by Design (QbD) methods have been used to improve processes across a variety of fields. The biopharmaceutical sector has recently embraced these methods, with the FDA advocating their use to ensure consistent product quality and lower product development and manufacturing costs. Read more.
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Vydac® Process Scale Up Of Protein And Polypeptides
By David Carr, Grace Vydac
Adsorption of proteins and polypeptides on reversed-phase columns is an all-or-nothing phenomenon. Their separation virtually always requires a gradient. Each polypeptide has a specific "desorption concentration" — the solvent concentration at which the polypeptide releases from the stationary phase and moves rapidly off the column. Read more.
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A Disposable Valve For Process Chromatography
By Michael Gagne, Aquasyn LLC
This case study discusses the need for a fully automated, disposable chromatography system which was PL-controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal as well as concentration and purification of biologically derived proteins used in the production of research and clinical materials. Read more.
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