Genetic Engineering & Biotechnology News

SEP15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Page 56 of 77 | SEPTEMBER 15, 2017 | 19 continuous processing could positively impact product quality, improve process consistency, potentially lower costs, and debottleneck operations. Two widely ref- erenced cases that make sense for CB are when the product is unstable or the cell line is a low producer and productivity needs improvement. At GE Healthcare, we have combined technologies and manufacturing expertise to offer biomanufacturers new approaches for CB. For example, rocking single-use (SU) bioreactors have been demonstrated as flexible tools for producing high cell densities in both fed-batch and perfusion modes. These bioreactors can also double as systems for generating high-density (HD) cell banks. These HD banks can be used in a one-step process to generate sufficient seed culture for inoculating a 2000-L bioreactor. 8 SU XDR bioreactors have been employed for continuous perfu- sion operations. 9 Downstream, continuous chromatography systems with real-time process monitoring and dynamic control have been connected to straight-through processing, utilizing in-line conditioning technology in an automated fashion to provide additional process intensification benefits. 10 O P T I M I Z I N G B I O P R O C E S S O P E R AT I O N S References 1. EvaluatePharma. World Preview 2017, Out- look to 2022. 10th Edition, June 2017. 2. Deloitte, "Advanced Biopharmaceutical Manufacturing: An Evolution Underway," (2015). 3. BioPlan Associates, 14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, (2017). 4. A. Sinclair, "Scale Up vs. Scale Out, What Drives the Decision," BioPharm Services, presentation at Bioprocess International West (March 2017). 5. K.B. Konstantinov and C.L. Clooney, "White Paper on Continuous Bioprocessing," (May 20–21, 2014). Continuous Manufacturing Symposium, J. Pharm. Sci. 104, 813–820 (2015). 6. J. Pollock, S.V. Ho, and S.S. Farid, "Fed-Batch and Perfusion Culture Processes: Economic, Environmental, and Operational Feasibility under Uncertainty," Biotechnol. Bioeng. 110, 206–219 (2013). 7. B. Kelley, "Perspectives of Continuous Bioprocessing," presentation at the CaSSS meeting (April 21, 2016). 8. GE Healthcare, Application Note, "One- Step Seed Culture Expansion from One Vial of High-Density Cell Bank to 2000 L Produc- tion Bioreactor," 29160932, Edition AB (2016). 9. J. Stout, "Shire's Manufacturing Strategy and New Flexible Facility: Completely Dis- posable Upstream and Traditional Stainless Downstream," presentation from the IBC Life Sciences 7th International Biopharmaceuti- cal Manufacturing and Development Sum- mit (September 12–14, 2011). 10. GE Healthcare, Application Note, "Contin- uous Chromatography in Downstream Pro- cessing of a Monoclonal Antibody," 29170800 Edition AA (2015). Table 3. Category Topic/issue Batch Continuous Connected batch Economic Capital cost Economic Utilization Economic Chromatography consumables–clinical production Economic Chromatography consumables– manufacturing Economic Buffer consumption Operational/ Economic Process and validation complexity Operational Manufacturing scale, scale-up risk Operational Complexity, training, skills Operational Process development, quality by design Technical Product quality/ consistency Downstream Bioprocessing: Breakdown of Risks and Benefits for Batch, Continuous, and Connected Approaches in Chromatography-Based Processes Risks and benefits are shown in a heat map, compiled based on the authors' continuous bioprocessing experience (bright red: high risk; bright green: greatest benefit). We encourage readers to perform their own assessments and to use the risk-benefit tables in this paper as a general guide. It is important to consider that the benefits could vary between different application areas (for instance, monoclonal antibodies, vaccines, recombinant proteins, and plasma).

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