Standard industry processes for recombinant antibody production employ protein A affinity chromatography in combination with other chromatography steps and ultra‐/diafiltration. This study compares a generic antibody production process with a recently developed purification process based on a series of selective precipitation steps. The new process makes two of the usual three chromatographic steps obsolete and can be performed in a continuous fashion. Cost of Goods (CoGs) analyses were done for: (i) a generic chromatography‐based antibody standard purification; (ii) the continuous precipitation‐based purification process coupled to a continuous perfusion production system; and (iii) a hybrid process, coupling the continuous purification process to an upstream batch process. The results of this economic analysis show that the precipitation‐based process offers cost reductions at all stages of the life cycle of a therapeutic antibody, (i.e. clinical phase I, II and III, as well as full commercial production). The savings in clinical phase production are largely attributed to the fact that expensive chromatographic resins are omitted. These economic analyses will help to determine the strategies that are best suited for small‐scale production in parallel fashion, which is of importance for antibody production in non‐privileged countries and for personalized medicine.
See accompanying commentary by Ajoy Velayudhan DOI: 10.1002/biot.201300098