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.

[1]  S Karri,et al.  A Tool for Modeling Strategic Decisions in Cell Culture Manufacturing , 2000, Biotechnology progress.

[2]  T Shanklin,et al.  Selection of bioprocess simulation software for industrial applications. , 2001, Biotechnology and bioengineering.

[3]  Wolf-Dieter Deckwer,et al.  Cost Comparison of Protein Capture from Cultivation Broths by Expanded and Packed Bed Adsorption , 2003 .

[4]  Suzanne S Farid,et al.  Decision‐Support Tool for Assessing Biomanufacturing Strategies under Uncertainty: Stainless Steel versus Disposable Equipment for Clinical Trial Material Preparation , 2008, Biotechnology progress.

[5]  Yuhong Zhou,et al.  A decisional-support tool to model the impact of regulatory compliance activities in the biomanufacturing industry , 2004, Comput. Chem. Eng..

[6]  Anthony Clemento.  New and Integrated Approaches to Successful Accelerated Drug Development , 1999 .

[7]  J. Shiloach,et al.  Large scale recovery and purification of periplasmic recombinant protein from E. coli using expanded bed adsorption chromatography followed by new ion exchange media. , 1996, Journal of biotechnology.

[8]  Yuhong Zhou,et al.  Application of a Decision‐Support Tool to Assess Pooling Strategies in Perfusion Culture Processes under Uncertainty , 2008, Biotechnology progress.

[9]  R G Werner.  Identification and development of new biopharmaceuticals. , 1998, Arzneimittel-Forschung.

[10]  Yuhong Zhou,et al.  A Software Tool to Assist Business‐Process Decision‐Making in the Biopharmaceutical Industry , 2005, Biotechnology progress.