Upstream Process Development
Upstream process is the first step of bioprocess from early cell isolation and cultivation,
to cell banking and culture development of the cells until final harvest where the desired quantity is reached.
Downstream Process Development
Purification begins with separating the cells from the media. In most mammalian cultures, the protein is secreted into the media, thus the supernatant must be collected for further purification. In microbial production, the protein can also accumulate within the cells, therefore the cells need to be disrupted and the cell debris separated from the protein of interest. Insoluble products including unfolded, pure proteins sticking together, known as inclusion bodies must be refolded to achieve their native and active conformation. Precipitation steps based on temperature, pH, or chemical interaction can be used for removal of process related impurities.