A downstream process is a series of separation steps leading to a purified protein product. The optimal process provides a product of specified quality, in terms of purity and consistency, at the lowest cost, within the constraint of acceptable market entry timing. The designer must also consider points such as sanitation, safety, and equipment flexibility. Within these restrictions the designer has considerable freedom to choose alternative unit operations for purification. The wide range of protein characteristics provides many options for purification steps. The assembly of a series of steps into an integrated process is guided by some type of model, be it an existing example, rules-of-thumb (heuristics), or a more complex algorithm. A review of heuristics for protein purification design in the light of heuristics for chemical purification design provides insight into the current state of large-scale protein purification.
Read full abstract