ambr 250 Fully Automated Single-Use Bioreactor System

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Marjorie Owens
7 years ago
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1 ambr 250 Fully Automated Single-Use Bioreactor System

2 A New Bioreactor System for Parallel Fermentation or Cell Culture ambr 250 is a new bioreactor system for parallel fermentation or cell culture using ml single-use bioreactors controlled by an automated liquid handling platform. The new system, developed with two major industrial partners, builds on TAP s successful micro bioreactor technology pioneered in the original ambr microscale system. ambr 250 takes ambr technology to the next level with a new platform that adds increased working fermentation volumes as well as individual control on all process parameters. This enhanced environment supports the culture requirements for high demanding microbial fermentation and mammalian cultures and applications where larger sample volumes are required. ambr 250 provides an efficient and rapid high throughput scale-down system at ml volumes to explore a wide range of conditions and strains with scalability to bench top stirred tank bioreactors. ambr 250 provides an efficient, high throughput scale-down model for process development and offers a step change improvement in lab productivity - A better tool for process development ambr 250 dramatically improves productivity and enables full DoE experiments to be performed at a fraction of the cost and with higher throughput than can be done in traditional bench top reactors. - Rapid evaluation of a wide range of conditions and cell line/strain performance ambr 250 provides a highly parallel system to rapidly develop processes for clones or strainsclones in a real bioreactor environment with full control of the culture conditions. - Excellent scalability to large scale bench top bioreactors ambr 250 is designed and tested to show that results from this scale-down system are predictive of full size bioreactors and fermenters up to 30 L. - Reduced infrastructure The low volume, compact, single use, fully disposable reactors remove the need for extensive cleaning and sterilization facilities and minimize the lab footprint. In addition the rapid turnaround means more experiments with less resources

The new system, developed with two major industrial partners, builds on TAP s successful micro bioreactor technology pioneered in the original ambr microscale system.

3 ambr 250 System Combines 12 or 24 Easy Connect Single-Use Bioreactors, Fully Automated Platform, Bioreactor Controller and Flexible System Control Software ambr 250 platform Fully automated - including media fill, inoculation, sampling and feeding with minimal operator interaction during the day 12 or 24 single-use bioreactors in parallel integrated control of multiple bioreactors offers efficient set-up and control and makes it simple to automate DoE experimental designs Integrated biological safety cabinet enclosure - for contamination free processing Automated liquid handler (10 ml and 300 ul pipettes) - for system set-up (media combination and addition), inoculation, bolus feeding and sampling into plates or tubes ambr 250 Bioreactor Vessels Disposable single-use bioreactors - no need to clean bioreactors and sensors between runs ml working volume reduces reagent costs while supporting enhanced off-line analysis using standard techniques Integrated ph and DO sensors vessel design incorporates disposable sensors to simplify the process of system preparation 3 step Easy Connect installation for all gas, liquid and sensor connections - Step 1 place vessel in holder and secure with clamp - Step 2 connect ph probe - Step 3 Clamp the vessel liquid manifold to the pump feed port Mammalian vessels ml working volume with baffles - Dual pitch blade impeller - Spot based DO sensor - Disposable ph electrode - Integrated gas and liquid inlet filters - Sparge and headspace gassing options - Robotic compatible cap for sampling - Integrated exhaust gas condenser Microbial vessels ml working volume with baffles - Dual 20 mm Rushton impeller - Spot based DO sensor - Disposable ph electrode - Integrated gas and liquid inlet filters - Robotic compatible cap for sampling - Sparge and overlay gassing options - Integrated condenser for output to exhaust gas analysis (OUR/CER) 4 4 5

efficient set-up and control and makes it simple to automate DoE experimental designs Integrated biological safety cabinet enclosure - for contamination free processing Automated liquid handler (10

4 Functions Applications ambr 250 automatically controls, feeds and samples 12 or 24 bioreactor/fermenter vessels in parallel ambr 250 is configurable for microbial fermentation or mammalian cell culture and able to model a wide range of requirements in a variety of applications across biopharm as well as individual biotech. Bioreactor controller - Three gasses per bioreactor with mass flow sensor: - Mammalian - O 2 - CO 2 - N 2 /air - Microbial - O 2 - Air - N 2 - Four positive displacement liquid pumps per bioreactor for high precision at low flow rates - Individual bioreactor temperature control with heating or cooling - Individual impeller speed control per bioreactor - Optional exhaust gas analysis for OUR/CER - Integrated CIP/SIP for pumps and liquid lines Control software - Fully flexible set up and control interface with simple, dialogue based interaction for quick and easy process creation. - Fine tuning options including programmable PID control loops and other advanced features - ambr 250 software is fully integrated with Umetrics MODDE Design of Experiment (DoE) application, enabling streamlined operation in execution of large DoE studies. - R&D and process development for biopharma - R&D and process development for industrial biotech - Process robustness experimentation in support of QbD studies - Automation of DoE approaches to process automation - Biofuels feedstock preparation R&D 6 6 7

Bioreactor controller - Three gasses per bioreactor with mass flow sensor: - Mammalian - O 2 - CO 2 - N 2 /air - Microbial - O 2 - Air - N 2 - Four positive displacement liquid pumps per bioreactor

5 Sales and Service Contacts For further contacts, visit Europe America Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse Goettingen Phone Fax Sartorius Stedim Systems GmbH Robert-Bosch-Strasse Guxhagen Phone Fax France Sartorius Stedim FMT S.A.S. ZI des Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Sartorius Stedim France SAS ZI des Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Austria Sartorius Stedim Austria GmbH Franzosengraben Vienna Phone Fax Belgium Sartorius Stedim Belgium N.V. Leuvensesteenweg, 248/B 1800 Vilvoorde Phone Fax Hungary Sartorius Stedim Hungária Kft. Kagyló u Budakeszi Phone Fax Italy Sartorius Stedim Italy S.p.A. Via dell Antella, 76/A Antella-Bagno a Ripoli (FI) Phone Fax Netherlands Sartorius Stedim Netherlands B.V. Phone Fax filtratie.nederland@sartorius-stedim.com Poland Sartorius Stedim Poland Sp. z o.o. ul. Wrzesinska Kostrzyn Phone Fax Russian Federation LLC Sartorius ICR and LLC Biohit Uralskaya str. 4, Lit. B , Saint-Petersburg Phone Fax Spain Sartorius Stedim Spain, S.A.U. Avda. de la Industria, 32 Edificio PAYMA Alcobendas (Madrid) Phone Fax Switzerland Sartorius Stedim Switzerland AG Ringstrasse 24 a 8317 Tagelswangen Phone Fax U.K. Sartorius Stedim UK Ltd. Longmead Business Centre Blenheim Road, Epsom Surrey KT19 9 QQ Phone Fax Sartorius Stedim Biotech UK formerly TAP Biosystems York Way, Royston, Herts, SG8 5WY Phone Fax Ukraine LLC Biohit Post Box 440 B Kiev, Ukraine Phone Fax USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY Toll-Free Fax Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone Fax Brazil Sartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP SP- Brasil Phone Fax Mexico Sartorius de México S.A. de C.V. Circuito Circunvalación Poniente No. 149 Ciudad Satélite 53100, Estado de México México Phone Fax Asia Pacific Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone Fax China No. 33 Yu an Road Airport Industrial Park Zone B Shunyi District, Beijing Phone Fax Shanghai Branch Office 3rd Floor, North Wing, Tower 1 No Jin Ke Road Pudong District, Shanghai Phone Fax Guangzhou Representative Office Unit K, Building 23 Huihua Commerce & Trade Building No. 80 Xianlie Middle Road Guangzhou Phone Fax India Sartorius Stedim India Pvt. Ltd. #69/2-69/3, NH 48, Jakkasandra Nelamangala Tq Bangalore, India Phone Fax Japan Sartorius Stedim Japan K.K. 4th Fl., Daiwa Shinagawa North Bldg. 8-11, Kita-Shinagawa 1-chome Shinagawa-ku, Tokyo, Japan Phone Fax Malaysia Sartorius Stedim Malaysia Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil Kuala Lumpur, Malaysia Phone Fax Singapore Sartorius Stedim Singapore Pte. Ltd. 1 Science Park Road, The Capricorn, #05-08A, Singapore Science Park II Singapore Phone Fax South Korea Sartorius Korea Biotech Co. Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, Phone Fax TAP Biosystems is now part of the Sartorius Stedim Biotech Group Specifications subject to change without notice. Publication No. : SBI1523-e Order No. : Ver

442.845600 Fax +33.442.845619 Sartorius Stedim France SAS ZI des Paluds Avenue de Jouques CS 71058 13781 Aubagne Cedex Phone +33.442.845600 Fax +33.442.846545 Austria Sartorius Stedim Austria GmbH Franzosengraben 12 1030 Vienna Phone +43.

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