Single-use technology has been around for approximately two decades if disposable capsule filters…
Host-cell proteins (HCPs) constitute a major part of process-related impurities during biologics…
In the past two decades, Protein A affinity chromatography has remained the de facto capture step…
This handbook describes the use of SEC for the purification and separation of biomolecules, with a focus on practical information for…
The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability…
A critical quality attribute (CQA) has been defined as “a physical, chemical, biological…
Once risk levels have been assigned to the CQAs, the next activity is to begin to relate which parts…
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