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26 BioPharm International eBook June 2019 Single-Use Systems Commercial Bioreactors "Optimal features include a cable management tree for easier handling of tubing and precision load cells. Sensors are single-use and autoclav- able. Open architecture approach can be integrated with any control system; however, the S.U.B. is most commonly integrated with the Thermo Scientific HyPerforma G3Pro Controller, a Delta V-based control platform running the TruBio software," according to Mullen. XCELLEREX GE Healthcare offers the Xcellerex platform, which offers a line of single-use stirred tank bioreactors, including 50-L, 200-L, 500-L, 1000- L, and 2000-L size bioreactors as well as the XDR-10 benchtop-scale biore- actor. In addition to stirred tank bio- reactors, the company also uses the wave 25 rocking bioreactor, which can be used as a seed bioreactor in an upstream train or development for media screening and process optimization, according to Yasser Kehail, bioprocess product manager, Xcellerex Hardware, GE Healthcare Life Sciences. The commercial-scale XDR-2000 bioreactor is designed mainly for mammalian cell lines producing monoclonal antibodies in a commer- cial manufacturing and GMP suite. However, during the past few years, GE Healthcare has seen different products produced using the XDR, such as enzymes (for enzyme replace- ment therapies), viral vectors (AAV for gene therapies), recombinant pro- teins (for human growth factors), and recombinant blood clotting factors, especially Factor 8. Key distinguishing features of these bioreactors include: • Turnkey solution with multiple automation platforms to choose from. The bioreactor could be a standalone unit with a control- ler running off of a Wonderware software, fully integrated solution with a Flexfactory, or connected in a distributed control system such as a Delta V with GE Healthcare library • Magnetically-driven bottom impel- ler, which reduces the minimum working volume • Robust bag design to minimize defect rates • Multiple options or a combination of micro- and macro-sparger, which provides high oxygen transfer, low carbon dioxide (CO 2 ) accumula- tion, and low shear profile. Standard components include: • Mass flow controllers to control gases (air, oxygen, CO 2 , and nitrogen) • Transmitters for process control and measurement (pH, dissolved oxy- gen [DO], temperature) • Pumps for liquid management (addition of cell-culture media, inoculation, and base control) • Stainless-steel jacketed vessel • Temperature control unit • Bag consumable that consists of the impeller, chamber, sparger plate, tubing, aseptic connectors (GE Readymates), and gas filters (over- lay, sparge, and exhaust). Sensors include Hamilton or Mettler Toledo pH or dissolved oxy- gen (DO) reusable sensor, Hamilton I nc y te v iable cel l- densit y sen- sor, Burns temperature sensor, and Pendotech pressure sensor. Optional components include viable cell den- sity probes and condensers. Multiple control systems are offered. The stan- dard standalone and Flexfactory units are designed with Wonderware soft- ware and Rockwell Hardware. There is also a new Delta V offering with GE Healthcare library, and if a client has a Delta V infrastructure, an XDR bio- reactor can be plugged in via profibus. ALLEGRO The Allegro STR bioreactor family combines Pall Biotech's bioprocess engineering expertise and cell culture know-how into a series of single-use bioreactors that deliver consistent and scalable cell-culture performance. The bioreactors have an intuitive turnkey bioreactor design concept to maxi- mize usability and process assurance while maintaining optimal perfor- mance needed in a cell-culture envi- ronment through several easy and intuitive operation features, accord- ing to Joseph Capone, senior global product manager at Pall Life Sciences. "All product contact surfaces are single-use components; therefore, the demands on maintenance, cleaning, and cleaning validation are minimal. This makes the system suitable for process development, contract man- ufacturing plants, or multiproduct manufacturing facilities where maxi- mum flexibility is required," Capone says. The system is designed for the fol- lowing production types: • Mammalian suspension cell culture, using (e.g., Chinese hamster ovary or HEK293 cells) • Insect cell-culture using (e.g., Sf9 cells) • Suspension cells in batch, fed- batch, and perfusion mode • Adherent cell growth on microcar- riers (e.g., VERO). T he si ngle bot tom-mou nted impeller design allows the biocon- tainer to be packed into a compact unit that can be placed directly into the hardware with minimal operator manipulation. Installation and infla- tion of the biocontainer is achieved in under 30 minutes through a guided sequence via the human machine interface (HMI). The low aspect ratio of the systems mini- mizes the operations that have to be performed at height. Automatic bio- container deflation speeds up turn- around time, minimizes operator activity, and reduces the overall vol- ume of waste for disposal. BIOSTAT The Biostat STR 2000 L from SSB is the largest size single-use bioreactor in the company's Biostat STR product

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