ABSTRACT
This chapter focuses on recovery of therapeutic recombinant proteins from microbial cells. The unit operations requiring validation include cell harvest, cell disruption, and either debris removal from a soluble protein or inclusion body recovery. At the completion of cell processing the product is commonly in inclusion bodies that can be frozen before further processing or can immediately proceed to the solubilization and refolding steps. The product can also be a soluble protein in a clarified lysate, ready for refolding and/or purification operations. This chapter does not address postrecovery operations. Inclusion body recovery and debris removal from a soluble protein are discussed as two distinct operations.
