title: The business impact of an integrated continuous biomanufacturing platform for recombinant protein production.
abstract: The biotechnology industry primarily uses batch technologies to manufacture recombinant proteins. The natural evolution of other industries has shown that transitioning from batch to continuous processing can yield significant benefits. A quantitative understanding of these benefits is critical to guide the implementation of continuous processing. In this manuscript, we use process economic modeling and Monte Carlo simulations to evaluate an integrated continuous biomanufacturing (ICB) platform and conduct risk-based valuation to generate a probabilistic range of net-present values (NPVs). For a specific ten-year product portfolio, the ICB platform reduces average cost by 55% compared to conventional batch processing, considering both capital and operating expenses. The model predicts that these savings can further increase by an additional 25% in situations with higher-than-expected product demand showing the upward potential of the ICB platform. The ICB platform achieves these savings and corresponding flexibility mainly due to process intensification in both upstream and downstream unit operations. This study demonstrates the promise of continuous bioprocessing while also establishing a novel framework to quantify financial benefits of other platform process technologies.
authors.affiliation: Late Stage Process Development, BioRealization, R&D, Sanofi, Framingham, MA 01701, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Walther
authors.affiliation: Late Stage Process Development, BioRealization, R&D, Sanofi, Framingham, MA 01701, USA. Electronic address: rahul.godawat@sanofi.com.
authors.forename: Rahul
authors.initials: R
authors.lastname: Godawat
authors.affiliation: Late Stage Process Development, BioRealization, R&D, Sanofi, Framingham, MA 01701, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Hwang
authors.affiliation: Biopharm Services, Chesham, HP51SD, UK.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Abe
authors.affiliation: Biopharm Services, Chesham, HP51SD, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Sinclair
authors.affiliation: Late Stage Process Development, BioRealization, R&D, Sanofi, Framingham, MA 01701, USA.
authors.forename: Konstantin
authors.initials: K
authors.lastname: Konstantinov
mesh_terms: D019149:Bioreactors / Q000191:economics; D001709:Biotechnology / Q000191:economics; D003132:Commerce; D004345:Drug Industry / Q000191:economics*; D008962:Models, Theoretical; D009010:Monte Carlo Method; D011994:Recombinant Proteins / Q000191:economics*; D012306:Risk
chemical_list: D011994:Recombinant Proteins
keywords: Biosolve; Continuous bioprocessing; Continuous capture; Cost of goods; Net present value; Perfusion cell culture