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Chesham, United Kingdom

Walther J.,Sanofi S.A. | Godawat R.,Sanofi S.A. | Hwang C.,Sanofi S.A. | Abe Y.,Biopharm Services | And 2 more authors.
Journal of Biotechnology

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. © 2015 Elsevier B.V. Source

Lim J.,Biopharm Services | Sinclair A.,Biopharm Services | Shevitz J.,Refine Technology | Carter J.B.,Refine Technology
BioPharm International

Fed-batch and perfusion culture are the two dominant modes of operation for mammalian-cell-culture based processes, especially for the production of glycosylated proteins required in large amounts. This article provides an economic comparison for the production of a typical glycosylated protein using the fed-batch, concentrated fed-batch (CFB), and concentrated perfusion (CP) technologies. The CFB and CP processes are based on the ATF System, a platform technology developed by Refine Technology for biologics production. Source

Sinclair A.,Biopharm Services | Monge M.,Biopharm Services
BioPharm International

As part of the Sanofi Pasteur Knowledge & Innovat ion for Technology Excel lence (KITE) initiative, we have been able to demonstrate the feasibi l ity of large-scale Vero cell culture in disposable bioreactors up to the 500-L scale. This included successful integration of the disposable process from seed to large-scale cell expansion and infection, including cell thawing and expansion directly in the disposable Nucleo 20 (a closed system for sampling, decontamination, and waste elimination) up to a 500-L working volume. Good virus yield and productivity were obtained in 20-, 200-, and 500-L scale disposable bioreactors. By using a validated BioSolve process modeling platform, we were able to identify where significant time and money savings could be achieved by implementing disposables. Sanofi intends to continue the scale-up program and will move to disposable industrial integration wherever is posables demonstrate benefits in line with the criteria defined in the KITE program. In the future, based on KITE program criteria, Sanofi Pasteur will in some cases consider hybrid processes involving a mixture of stainless steel and disposable technologies to solve ergonomic and large equipment decontamination issues. Source

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