Single-Use Bioreactor - 6 Pages

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Single-Use Bioreactor

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sartoriusstedim biotech Large-Scale Perfusion and Concentrated Fed-Batch Operation of BIOSTAT® STR Single-Use Bioreactor turning science

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By Christel Fenge, Jorg Weyand, Gerhard Greller, Thorsten Adams Sartorius Stedim Biotech Introduction Perfusion is a well known production approach since many years for a number of biological drugs such as coagulation factors (Factor VIII: Kogenate, Bayer and Refacto, Pfizer; Factor VII: Novoseven, Novo Nordisk), Protein C (Xigris, Eli Lilly) and other enzymes but also monoclonal antibodies (ReoPro and Remicade, both Janssen Biotech; Simulect, Novartis, etc.). Recently, perfusion has been used also to generate high cell density seed cultures to reduce the number of seed steps necessary to...

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Exhaust cooler Bleed pump Feed pump Balance BioPAT® Trace Glucose Lactate PO2 T Filtrate pump BioPAT® ViaMass Cell density & viability Fig. 1: et-up of a concentrated fed-batch using the single-use Bioreactor S BIOSTAT® STR. Fig. 2: lexAct® MP – Disposable solution for media preparation. F Key considerations Typical perfusion rates are in the range of 1 – 2 bioreactor volumes per day. Applying a small cell bleed stream enables the establishment of a defined cell growth rate and by that a high viability can be maintained which in turn mitigates clogging of the cell retention device [5]....

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Scaling up continuous processing Concentrated fed-batch and perfusion processes can be developed and successfully implemented at production scale using Sartorius stirred tank single-use bioreactors in combination with different sizes of the Refine ATF module. At the 2L bench scale, e.g. our UniVessel® in combination with our BIOSTAT® B or B-DCU controller provides a fully scalable development system. Subsequent scale-up from 50L and 200L can be achieved to the 1000L scale in the BIOSTAT® STR. At large-scale, the ATF modules might be connected via side ports of the single-use bioreactor bag...

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Conclusion Modern single-use bioreactor designs such as of the BIOSTAT® STR allow advanced, intensified cultivation strategies whilst providing tools to mitigate operational risks associated to a complex bioprocessing strategy and thus enabling robust single-use production for clinical trials and commercial drug manufacturing. References 1. . Heidemann et al., Cytotechnol. 38 R (1–3), 99–108 (2002) 2. . Adams et al., BioPharm Int. T Supplement May 2011, S4-S11 3. . Lim, et al., BioPharm Int. 24 (2), J 54–60 (2011) 4. . Pollock et al., Biotechnol. and J Bioeng. 110 (1), 206-219 (2013) 5. ....

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For further contacts, visit www.sartorius-stedim.com Europe America Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen Phone +49.551.308.0 Fax +49.551.308.3289 Italy Sartorius Stedim Italy S.p.A. Via dell'Antella, 76/A 50012 Antella-Bagno a Ripoli (FI) Phone +39.055.63.40.41 Fax +39.055.63.40.526 USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY 11716 Toll-Free +1.800.368.7178 Fax +1.631.254.4253 India Sartorius Stedim India Pvt. Ltd. #69/2-69/3, NH 48, Jakkasandra Nelamangala Tq 562 123 Bangalore, India Phone +91.80.4350.5250 Fax...

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