Upstream Processing (USP)
Categories:
Definition
The earliest stage of drug development. The initial steps of the upstream process start with milliliter quantities of mammalian or microbial cells engineered to produce a specific protein molecule. Using several cultivation steps in a controlled environment within a bioreactor, these cell cultures are grown to a volume of several thousand liters to produce several kilograms of the desired Active Pharmaceutical Ingredient (API). Process development involves optimization of media/feed strategy and scale -up from lab scale. The aim is to develop a high quality protein at optimum yield.