ambr 250 high throughput High Performance Single-Use Fully Automated Bioreactor System

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1 ambr 250 high throughput High Performance Single-Use Fully Automated Bioreactor System

2 A Fully Automated Bioreactor System for Parallel Fermentation or Cell Culture ambr 250 high throughput is a enhanced parallel microbial or cell culture system using ml single-use bioreactors with a fully automated liquid handling platform. The system provides a high precision environment that supports the demands of microbial fermentation and mammalian cultures. ambr 250 high throughput provides an efficient and rapid scaledown system to explore a wide range of conditions and strains with scalability to both bench top and larger stirred tank bioreactors. Productivity 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. Wide Range of Cell Strain Conditions and Performance ambr 250 provides a highly parallel system to rapidly develop processes for clones or strains in bioreactors that have full individual control of culture conditions. Scalability Because the bioreactor vessels are geometrically similar to larger bioreactors, all processes on the system correlate empirically to those of larger bioreactors making for optimum scalability. Convenience With a fully automated liquid handler together with single-use bioreactors that are fully integrated to sensors, users no longer need to spend long hours in the lab, manipulating, cleaning or setting up. 2 2

3 ambr 250 high throughput 3

4 ambr 250 high throughput System Combines 12 or 24 Easy Connect Single-Use Bioreactors, Fully Automated Platform, Bioreactor Controller and Flexible System Control Software ambr 250 platform Integrates bioreactor stations, sensor readers, pumps and a liquid handler resulting in an efficient, high throughput scale-down model for process development and optimization. Automated liquid handler Fully automated liquid handler, for all liquid samples and additions, significantly reducing manual operator interactions. 4 4

5 Integrated biological safety cabinet A class II biological safety cabinet designed to maintain an aseptic environment even during robot manipulation of bioreactors, significantly reducing any risk of vessel contamination Bioreactor station array 12 or 24 bioreactor stations in parallel with full individual process control, offers convenient set-up and simplifies running of full DOE experiments. 5

6 ambr 250 high throughput Single-Use Bioreactor Vessels Each bioreactor is equipped with impellers for stirring, a ph and DO sensor and ports to connect to the system s liquid and gas lines. The single-use technology means there is no need to clean bioreactors and sensors between runs. Mammalian or microbial vessels ml working volume with baffles Dual 20 mm pitched-blade or 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) 6

7 Septum cap Allows for rapid liquid additions with a syringe. Gas tube Gases can either be delivered into the headspace or sparged into the media. These delivery systems are independent and can function in parallel. Integrated ph and DO sensors vessel design incorporates disposable sensors to simplify the process of system preparation. Double impeller Rushton or pitch blade For microbial or mammalian vessels respectively. 7

8 Functions ambr 250 high throughput automatically controls, feeds and samples 12 or 24 bioreactor/fermenter vessels in parallel 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. 8 8

9 Applications 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 industrial biotech. - Process optimization - Process characterization - Process robustness experimentation in support of QbD studies. - Process scale-down model. 9

10 Scalability Single-Use from Cell Line and Process Development to Production Scale - Geometrical similarity of vessel design - Consistent mixing and gassing strategies - Reliable single-use platform ambr 250 high throughput BIOSTAT B Univessel SU 2L BIOSTAT STR 50 Similar Geometry and Sensors - Process development 10

11 ambr 250 high throughput BIOSTAT B UniVessel Glass L WV Also scalable to multi-use technologies Biostatl Cplus 5-30 L WV BIOSTAT STR 200 BIOSTAT STR 500 BIOSTAT STR 1000 scaling up from 0.25 L to 1000 L Production 11

12 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 Modecenterstrasse Vienna Phone Fax Belgium Sartorius Stedim Belgium N.V. Rue Colonel Bourg Bruxelles 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 Stedim RUS Uralskaya str. 4, Lit. B St. 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 Royston-Info@sartorius.com Royston-Orders@sartorius.com Ukraine LLS Sartorius RUS 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. Libramiento Norte de Tepotzotlan s/n, Colonia Barrio Tlacateco, Municipio de Tepotzotlan, Estado de México, C.P Phone Fax leadsmex@sartorius.com Peru Sartorius Peru S.A.C. Av. Emilio Cavenecia 264 San Isidro Lima, Perú Phone Fax Asia Pacific Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone Fax China Sartorius Stedim Biotech (Beijing) Co. Ltd. No. 33 Yu an Road Airport Industrial Park Zone B Shunyi District, Beijing 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 Sartorius Stedim (Shanghai) Trading Co., Ltd. 3rd Floor, North Wing, Tower 1 No Jinke Road Zhangjiang Hi-Tech Park Pudong District Shanghai , P.R. China Phone Fax Sartorius Stedim Biotech (Beijing) Co. Ltd. Guangzhou Representative Office Unit K, Building 23 Huihua Commerce & Trade Building No. 80 Xianlie Middle Road Guangzhou Phone Fax Specifications subject to change without notice. Publication No. : SBI1523-e Order No. : Ver