Aqueous two-phase extraction as a platform in the biomanufacturing industry: Economical and environmental sustainability

• Published in: Biotechnology advances 2011-11, Vol.29 (6), p.559-567
• Main Authors: Rosa, P.A.J., Azevedo, A.M., Sommerfeld, S., Bäcker, W., Aires-Barros, M.R.
• Format: Article
• Language: English
• Subjects: affinity chromatography; Aqueous two-phase systems; Biological and medical sciences; Biotechnology; Biotechnology - economics; Biotechnology - methods; business enterprises; cell culture; Chromatography, Affinity; Drug Industry - economics; Drug Industry - methods; Economical analysis; Environment; environmental impact; Environmental sustainability; Fundamental and applied biological sciences. Psychology; Green Chemistry Technology; Humans; industry; Liquid-Liquid Extraction - economics; Liquid-Liquid Extraction - methods; monoclonal antibodies; operating costs; Protein A affinity chromatography; proteolysis; purification methods; Purification of antibodies; resins
• ISSN: 0734-9750; 1873-1899
• DOI: 10.1016/j.biotechadv.2011.03.006

The biotech industry is, nowadays, facing unparalleled challenges due to the enhanced demand for biotechnology-based human therapeutic products, such as monoclonal antibodies (mAbs). This has led companies to improve substantially their upstream processes, with the yield of monoclonals increasing to titers never seen before. The downstream processes have, however, been overlooked, leading to a production bottleneck. Although chromatography remains the workhorse of most purification processes, several limitations, such as low capacity, scale-related packing problems, low chemical and proteolytic stability and resins' high cost, have arisen. Aqueous two-phase extraction (ATPE) has been successfully revisited as a valuable alternative for the capture of antibodies. One of the important remaining questions for this technology to be adopted by the biotech industries is, now, how it compares to the currently established platforms in terms of costs and environmental impact. In this report, the economical and environmental sustainability of the aqueous two-phase extraction process is evaluated and compared to the currently established protein A affinity chromatography. Accordingly, the ATPE process was shown to be considerably advantageous in terms of process economics, especially when processing high titer cell culture supernatants. This alternative process is able to purify continuously the same amount of mAbs reducing the annual operating costs from 14.4 to 8.5 million (US$/kg) when cell culture supernatants with mAb titers higher than 2.5g/L are processed.