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TUTORIAL Bioprocessing Automated Bioreactor for Adherent Culturing A Closed System Can Reduce the Number of Open Events and Improve Sterility James Beltzer, Ph.D. Current potential bioprocess solutions for the scaleup of adherent cells include cell stacks, robotic fask handling, packed-bed culture, hollow-fber bioreactors, and microcarriers or aggregate culture in stirred tanks. Cell stacks and robotic fask handling can increase the total surface area in culture but do not remove the open events (e.g., taking the top off a T-fask and exposing it to potential contamination) from the process or eliminate the wasteful feeding strategies inherent to fask-based systems. Packed-bed systems have traditionally been used for protein and antibody production and are not designed for the effcient recovery of cells. The growth of cells on microcarriers can result in mechanical damage to the cells and diffculty removing the microcarriers from the cell product. Maintaining the proper aggregate size and cell viability in stirred tank bioreactors can require the use of enzymatic or mechanical methods that can damage the cells. Automation has been defned as a handoff of tedious and routine tasks to more effcient and reliable machines. Progress in bioprocess automation has been slow because many of the current instruments are not up to the task. Automation of a fask-based manual cellculture process can solve many of the prob- Performance Flexibility Scalability Have it all with MaxCyte flow transfection. Don't settle for other transfection technologies. MaxCyte flow electroporation is a rapid, universal transient transfection platform that has unmatched performance, flexibility, and scalability. Transfect primary cells, stem cells, and cell lines with DNA, mRNA, siRNA, proteins, or other molecules of interest at any scale with superior cell viabilities and transfection efficiencies. MaxCyte flow electroporation is highly scalable for transfection of 5E5 cells in seconds up to 2E11 cells in less than 30 minutes and has been validated in cell-based assays, protein production, and cell therapy applications. Transfect ANY CELL with ANY MOLECULE at ANY SCALE! MaxCyte STX® Scalable Transfection System - fully scalable from 5E5 to 1E10 cells MaxCyte VLX® Very Large Transfection System - for up to 2E11 cells MaxCyte GT® Transfection System- clinical-grade for cell therapy applications, scalable from 5E5 to 1E10 cells lems of scaleup. A closed system reduces the number of open events and improves sterility. Automation can reduce labor costs and improve throughput. Improved product quality and reduced variability can lead to better regulatory compliance and contain cost. Automation of process steps eliminates human inconsistencies and errors while maintaining optimized culture conditions across multiple manufacturing sites. Finally, automation can aid in regulatory compliance and improve product comparability by locking in process changes. Automated Hollow-Fiber Bioreactor Terumo BCT's Quantum® cell expansion system is an automated hollow-fber bioreactor designed for the culture of adherent cells. The closed system can automate many of the tasks associated with fask-based culture, including cell seeding, reagent addition, feeding, and harvest. Extensive work in our laboratory and the laboratories of others have shown that cells grown in the system meet or exceed the International Society for Cell Therapy standards. Mesenchymal stem cells grown displayed identical or improved morphology, phenotype, differentiation capacity, and karyotype (when compared to cells cultured on tissue culture treated polystyrene. The largest change one can achieve with the system is the elimination of the handling (and open events) of numerous fasks required for the production of millions to billions of cells. For example, a fask-based system for the production of two billion fbroblast cells would require the handling of over one hundred fasks, two weeks of culture time, and multiple operators. The same number of cells produced in a Quantum system would take just six days and could be managed by an individual working part time (Table 1). The instrument uses a number of predefned tasks to replicate the cell culture process from cell seeding to harvest. Each task can be customized to match the needs of a particular cell type. The system is controlled by a graphical user interface. Once optimized, a process can be locked to improve reproducibility and decrease run-to-run variability. Manufacturing Comparison Flask Time (weeks) Contact MaxCyte to accelerate your product development with the transfection method used by leading pharmaceutical and biotherapeutic companies. People Tel: (301) 944-1700 • email: info@maxcyte.com • www.maxcyte.com 2 1 5–14 1 42 | September 1, 2013 | GENengnews.com | Genetic Engineering & Biotechnology News 135 1 1,200 4 Incubators 3–5 1 Hoods MaxCyte, MaxCyte STX, and MaxCyte VLX are registered trademarks of MaxCyte, Inc. ©MaxCyte, Inc. 2013. All rights reserved. Disposable (fask/set) Quantum System 3–5 1 Open Events Table 1. Manufacturing comparison of a faskbased system and the Quantum system for the production of two billion cells.