ABSTRACT
The manufacturing of biopharmaceuticals encompasses a string of activities that are designed with the goal of producing a certain mass or biological activity of a target product with specific quality attributes. The downstream processing is indisputably the most challenging stage in biopharmaceutical manufacturing. The selection of a train of recovery and purification operations requires an adequate knowledge of the properties of the target molecule and associated impurities. The majority of the enzymes used in these categories are hydrolases, which fall within the Enzyme Commission enzyme class. Enzymes can be used as process additives very early in a biopharmaceutical manufacturing process to tackle specific challenges linked to cell dissociation and cell lysis. The majority of mammalian cells that are cultured in vitro in petri dishes, flasks, and bioreactors adhere to the substrate surfaces by a sequence of steps that includes an initial attachment, flattening and spreading.
