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>depth filtration</span>
One of the biggest challenges in the production of recombinant therapeutic proteins, monoclonal antibodies, and vaccines is the clarification and separation of the product (typically a protein) from the cell culture or fermentation broth. The desired product is present in low concentrations and must be efficiently separated from the other components present in the bioreactor fluid. An overall objective in developing a clarification process is to achieve the highest level of product recovery (yield) and contaminant removal with the fewest number of unit processes. Understanding how each operational step affects the performance of the next step downstream is the challenge at hand. Centrifugation, in combination with depth filtration, is gaining acceptance as the preferred method for the removal of cells, cell debris, colloids, insoluble precipitants, aggregates, and other materials found in mammalian cell culture and bacterial fermentation fluids…