Can I read Effect of Phenyl Sepharose Ligand Density on Protein Monomer/aggregate Purification and Separation Using Hydrophobic Interaction Chromatography on EtoBox?

Effect of Phenyl Sepharose Ligand Density on Protein Monomer/aggregate Purification and Separation Using Hydrophobic Interaction Chromatography by Justin T. McCue; Philip Engel; Jörg Thömmes is a Chemistry article available to read on EtoBox.

What is Effect of Phenyl Sepharose Ligand Density on Protein Monomer/aggregate Purification and Separation Using Hydrophobic Interaction Chromatography about?

In the large-scale manufacturing and purification of protein therapeutics, multiple chromatography adsorbent lots are often required due to limited absorbent batch sizes or during replacement at the end of the useful column lifetime. Variability in the adsorbent performance from lot to lot should be minimal in order to ensure that consistent product purity and product quality attributes are achieved when a different lot or lot mixture is implemented in the process. Vendors of chromatographic adsorbents will often provide release specifications, which may possess a narrow range of acceptable values. Despite relatively narrow release specifications, the performance of the adsorbent in a given purification process could still vary from lot to lot. In this case, an alternative use test (one that properly captures the lot to lot variability) may be required to determine an acceptable range of variability for a specific process. In this work, we describe the separation of therapeutic protein monomer and aggregate species using hydrophobic interaction chromatography, which is potentially sensitive to adsorbent lot variability. An alternative use test is formulated, which can be used to ra

Who reads Effect of Phenyl Sepharose Ligand Density on Protein Monomer/aggregate Purification and Separation Using Hydrophobic Interaction Chromatography?

Author

Justin T. McCue; Philip Engel; Jörg Thömmes

Publisher

Elsevier Science; Elsevier ; Elsevier BV (ISSN 1873-3778)

Published

2009

Language

EN

Field

Chemistry (Physical Sciences)