The production of biopharmaceutical drugs typically involves a biological expression within a bacterial, yeast, or mammalian cell expansion system. Getting to the final product requires multiple purification steps, from primary clarification to the final formulation and sterile filtration. The aim of the initial purification steps is not to purify the stream perfectly but rather, to prepare the stream for finer and more specific purification steps further downstream. Apart from efficiently removing contaminants, the clarification stages also need to maintain high product recovery whilst being consistent and robust.
Tag: <span>hydrophobic interaction chromatography</span>
The outstanding success and safety record of first generation monoclonal products has created an immense increase in the number of product candidates that need to be evaluated clinically. The concept of platform purification has emerged in response to this need. A platform is a semigeneric, multistep purification procedure that can be applied to a wide range of monoclonal antibodies without extensive method-scouting and optimization. This approach can substantially accelerate process development and hasten inception of clinical trials…