ABSTRACT

The manufacturing of recombinant DNA products is divided into two distinct steps:

Upstream processing consists of: a pure culture of the chosen organism, in sufficient quantity and in the correct physiological state; sterilized, properly formulated media, a seed bioreactor to develop inoculum to initiate the process in the main bioreactor; the production scale bioreactor.

Downstream processing consists of: equipment for drawing the culture medium in steady state, cell separation, collection of cell free supernatant, product purification, and effluent treatment.