Retrofit Decisions within the Biopharmaceutical Industry: An EBA Case Study

A key issue within the biopharmaceutical industry is the potential feasibility of retrofits as a means of reducing operating costs and improving process efficiency. This paper presents a framework, designed to capture both process and business aspects of such a decision. This allows analysis of the key economic and technical elements and the overall feasibility of a retrofit.An expanded bed adsorption (EBA) retrofit is used as a case study to demonstrate the functionality of the tool. The tool provides an overall insight into the feasibility of the introduction of EBA to replace elements of a conventional packed-bed based process. The analysis illustrates how the feasibility of retrofits alters as a function of the year of retrofit introduction, the cost associated with the downtime due to the retrofit change, and the revalidation costs. The use of feasible space plots to highlight the consummation of conditions that will yield an acceptable retrofit solution is presented.