Contribution of protein A step towards cost of goods for continuous production of monoclonal antibody therapeutics. Issue 9 (11th March 2021)

• Record Type: Journal Article
• Authors: Bansode, Vikrant; Gupta, Paridhi; Kateja, Nikhil; Rathore, Anurag S
• Is Part Of: Journal of chemical technology & biotechnology. Volume 97:Issue 9(2022)
• Page Start: 2420
• Page End: 2433
• Publication Date: 2021-03-11
• Subjects: continuous processing -- economic analysis -- cost evaluation -- biotherapeutics -- monoclonal antibodies -- non‐protein a purification; Biotechnology -- Periodicals; Chemistry, Technical -- Periodicals; Chemical engineering -- Periodicals; Industries -- Environmental aspects -- Periodicals; 660
• DOI: 10.1002/jctb.6686
• Languages: English
• ISSNs: 0268-2575

Abstract

Abstract: BACKGROUND: Monoclonal antibodies (mAbs) presently dominate the biotherapeutic market. However, biotherapeutics in general, and mAbs in particular, are expensive therapies and outside the realm of affordability for most of the world. In an attempt to lower their cost of manufacturing, a novel in‐house non‐protein A continuous platform has recently been reported for mAb purification. In this paper, we perform an in‐depth evaluation of the process economics to assess the impact of removing the protein A step on the cost of goods (COGs). RESULTS: The non‐protein A platform was found to result in significant savings in COGs at about 23% when comparing both platforms in batch mode. Conversion of the non‐protein A platform from batch to continuous mode led to a further increase in these savings with about 39% gains in COGs over the conventional protein A platform. CONCLUSIONS: The non‐protein A purification platform offers a viable alternative to the standard protein A platform and can be considered when setting up a new facility. The continuous non‐protein A platform can especially be considered given the flexibility of the setup and the utility at both small and large scales. © 2021 Society of Chemical Industry