BIOSTAT RM and Flexsafe RM for Seed Production and Small Scale Protein Supply

Transcription

1 BIOSTAT RM and Flexsafe RM for Seed Production and Small Scale Protein Supply

2 BIOSTAT RM and Flexsafe RM Bags The BIOSTAT RM, a fully GMP compliant, single-use, wave-mixed bioreactor and Flexsafe bags are proven for a broad range of different cell lines incl. CHO, NS0, SF9, E.coli and mesenchymal stem cells. Benefit from our excellent global application support and technical service and get started right away. Process Step Cells Purpose Volumes Protein and cell supply for preclinical purposes Seed production for large bioreactors GMP production Mammalian, insect and plant cells Suspension cells and adherent cells on microcarriers Low to medium density microbial cultures Shear sensitive cells such as stem cells Scale-up from shake 100 ml to 100 L culture or T-flasks volume Rapid material supply Two rocker sizes: 20/50 for pre-clinical trials and 200 Expansion and differentiation of stem cells Production of recombinant proteins, mabs and vaccines Continuous cultures with reported cell densities of 150 million cells/ml

3 Excellent Cell Growth and Robustness Security of Supply & Consistent Quality Easy to Use Rocker with Advanced Control Capabilities

4 New One for All Bag Family Use our Flexsafe RM bags in your seed train and scale-up to our BIOSTAT STR single-use stirred tank bioreactors equiped with Flexsafe STR bags. Benefit from the same polyethylene film material across all your cell culture steps. 1L Flexsafe RM Advanced Control System Do you want to run fully automated and controlled batch, fed-batch or high cell density perfusion cultures? Combine your basic rocker with our BIOSTAT B control tower and use Flexsafe RM bags equiped with single-use ph and DO probes. 200 L Our Flexsafe RM bags fit on rocking motion bioreactors from several manufacturers. Benefit from excellent cell growth, robustness and unprecedented assurance of supply. Advanced control of gas mixture and flow rate, filling volume and substrate addition Extra small space requirement with TWIN configuration two culture systems controlled by one controller at the same time Cell Growth Cell Density Flexsafe ensures an excellent and reproducible growth behavior with the most sensitive production cell lines. The complete control of our raw materials, the extrusion process and the bag assembling guarantees consistent lot to lot cell growth performance. Your BIOSTAT B controller is designed to work with a conventional glass vessel, the single-use UniVessel SU and the RM rocker, making it a real multi talent. It allows you to use the same controller platform for research purposes, process development and preclinical supply. To ensure consistent cell growth performance, we optimized the resin and minimized the additive package in collaboration with our resin and film suppliers. Reference Flexsafe bags Standard bags Watch Video: Time Robustness The thickness, strength and flexibility of the new polyethylene film enhances the mechanical robustness of Flexsafe, making it ideal for all bioprocessing applications. The strength of Flexsafe significantly reduces the risk of accidental damage to the bag due to inappropriate handling. Its flexibility enables convenient installation and self-deployment of the bag in its container. Bag A Bag B Bag C Flexsafe Energy at Break Assurance of Supply Flexsafe provides you with an unprecedented assurance of supply and enables robust business continuity plans. Our strategic partnership with resin and film suppliers ensures full traceability of raw materials and control over the entire manufacturing process from the resins to the final assembled bags. 10-year contract with the film manufacturer Last time buy option for minimum of 2 years resin demand Up to 2 years safety stock of film Multiple manufacturing sites BIOSTAT RM Basic Designs The bags come in 7 different sizes supporting working volumes from 100 ml up to 100 L. Standard designs are available from stock. Basic Bag For cultivation under constant conditions without ph and DO control for seed train With single-use ph and DO sensors installed in bag for advanced applications With integrated perfusion membrane, fixed at the bottom of the bag, for continuous processing with low membrane fouling and long cultivation times With single-use biomass (ViaMass) sensors* Available with screw caps for bulk additions Customized bag designs Can be used on competitor systems * in development. Optical Bag Perfusion Bag The BIOSTAT RM basic is a perfectly sized, stand-alone bioreactor for benchtop use. It features an exchangeable bag holder to fit bags from 1 L to 50 L total volume. The BIOSTAT RM basic rocker with integrated local controller, Air CO2 mixing module and load cells is the optimal choice for straight forward applications such as seed generation. Space-saving, individual control of two bags on the same platform Advanced alarming and safety features for safe cultivation Reduced manual handling via automated sampling function

5 New One for All Bag Family Use our Flexsafe RM bags in your seed train and scale-up to our BIOSTAT STR single-use stirred tank bioreactors equiped with Flexsafe STR bags. Benefit from the same polyethylene film material across all your cell culture steps. 1L Flexsafe RM Advanced Control System Do you want to run fully automated and controlled batch, fed-batch or high cell density perfusion cultures? Combine your basic rocker with our BIOSTAT B control tower and use Flexsafe RM bags equiped with single-use ph and DO probes. 200 L Our Flexsafe RM bags fit on rocking motion bioreactors from several manufacturers. Benefit from excellent cell growth, robustness and unprecedented assurance of supply. Advanced control of gas mixture and flow rate, filling volume and substrate addition Extra small space requirement with TWIN configuration two culture systems controlled by one controller at the same time Cell Growth Cell Density Flexsafe ensures an excellent and reproducible growth behavior with the most sensitive production cell lines. The complete control of our raw materials, the extrusion process and the bag assembling guarantees consistent lot to lot cell growth performance. Your BIOSTAT B controller is designed to work with a conventional glass vessel, the single-use UniVessel SU and the RM rocker, making it a real multi talent. It allows you to use the same controller platform for research purposes, process development and preclinical supply. To ensure consistent cell growth performance, we optimized the resin and minimized the additive package in collaboration with our resin and film suppliers. Reference Flexsafe bags Standard bags Watch Video: Time Robustness The thickness, strength and flexibility of the new polyethylene film enhances the mechanical robustness of Flexsafe, making it ideal for all bioprocessing applications. The strength of Flexsafe significantly reduces the risk of accidental damage to the bag due to inappropriate handling. Its flexibility enables convenient installation and self-deployment of the bag in its container. Bag A Bag B Bag C Flexsafe Energy at Break Assurance of Supply Flexsafe provides you with an unprecedented assurance of supply and enables robust business continuity plans. Our strategic partnership with resin and film suppliers ensures full traceability of raw materials and control over the entire manufacturing process from the resins to the final assembled bags. 10-year contract with the film manufacturer Last time buy option for minimum of 2 years resin demand Up to 2 years safety stock of film Multiple manufacturing sites BIOSTAT RM Basic Designs The bags come in 7 different sizes supporting working volumes from 100 ml up to 100 L. Standard designs are available from stock. Basic Bag For cultivation under constant conditions without ph and DO control for seed train With single-use ph and DO sensors installed in bag for advanced applications With integrated perfusion membrane, fixed at the bottom of the bag, for continuous processing with low membrane fouling and long cultivation times With single-use biomass (ViaMass) sensors Available with screw caps for bulk additions Customized bag designs Can be used on competitor systems * in development. Optical Bag Perfusion Bag ()* The BIOSTAT RM basic is a perfectly sized, stand-alone bioreactor for benchtop use. It features an exchangeable bag holder to fit bags from 1 L to 50 L total volume. The BIOSTAT RM basic rocker with integrated local controller, Air CO2 mixing module and load cells is the optimal choice for straight forward applications such as seed generation. Space-saving, individual control of two bags on the same platform Advanced alarming and safety features for safe cultivation Reduced manual handling via automated sampling function

6 BIOSTAT RM 200 The BIOSTAT RM 200 is your choice for larger scale seed expansion and production of material for preclinical and clinical studies. It supports working volumes from 10 L up to 100 L. Low consumable costs compared to stirred single-use bioreactors Reliable single-use probes for measurement of ph and DO Designed for automated batch and fed-batch processes Security of Supply & Consistent Quality Flexsafe RM bags provide you with unprecedented assurance of supply. Our strategic partnership with resin and film suppliers ensures full traceability of raw materials and control over the entire manufacturing process from the resins to the final assembled bags.

7 Technical Specifications Flexsafe RM Bags Total Volume (L) Working volume (L)* Bag Types Basic Basic and optical with screw cap Optical Perfusion with integrated membrane Perfusion with connection to ATF module Main Components Basic Optical Perfusion Connectors Female Male Luer Female Male MPC Female Male Luer Female Male MPC Female Male Luer Female Male MPC Filters Air Inlet Air Outlet Air Inlet Air Outlet Air Inlet Air Outlet Ports Sampling Fill harvest with dip tube Acid Base Sampling Fill harvest with dip tube Acid Base Sensors Optical chemical ph Optical chemical DO (ViaMass) Sampling Fill harvest with dip tube Acid Base Perfusion feed harvest Optical chemical ph Optical chemical DO (ViaMass) Perfusion Perfusion membrane PES 1.2 µm Opta aseptic connector to ATF system Tubing material C.Flex 374, Silicone, PharMed Natvar ABL-1222 TPE Material of the bag Contact layer: LLDPE gas barrier: EVOH outer layer: LLDPE Production conditions Cleanroom environment of at least ISO 8 Biological reactivity USP for plastics Class VI Sterility ISO sterility assurance level (SAL) of 10-6 TSE/BSE status Compliant to EMA410/01/rev.3 guideline Endotoxin USP<85> for sterile water for injection; < 0.25 EU/ml Irradiated kgy * Bags with sensors might require higher minimum working volumes depending on rocking rate and angle. Ordering Information Flexsafe RM Basic Basic with screw cap 1 L DFB001L Optical Perfusion pro 1.2 µm Perfusion ATF 2 L DFB002L DFB SC DFO002L DFP002L--SM DFP002L--AT 10 L DFB010L DFB SC DFO010L DFP010L--SM DFP010L--AT 20 L DFB020L DFB SC DFO020L DFP020L--SM DFP020L--AT 50 L DFB050L DFO050L DFP050L--SM DFP050L--AT 50 L alternative dimension* DFB050L----01US 100 L DFB100L DFO100L DFP100L--AT 200 L DFB200L DFO200L DFP200L--AT * mm suitable for competitor rocker

8 Technical Specifications Laboratory Supply Requirements BIOSTAT RM BIOSTAT RM & Control Tower BIOSTAT RM 200 Power Supply (Country Specific) Power Frequency Consumption Protection Class Rocker platform V Hz 600 W IP V Hz 600 W IP23 Control Tower 230 V 50 Hz 10 A IP21 or 120 V 60 Hz 12 A IP V 3 phase TN-S 30 A IP43 or 400 V 3 phase TN-S 32 A IP43 Load cells V 15 W V 15 W Gas Supply Inlet pressure (barg) Quick coupling for gas tubes, Festo Type d 4 mm (d 6 mm) (d 6 mm) Connection hose coupling, external d 6 mm d 6 mm Gas Specification According to ISO : Dry, Oil and Dust Free Particle size: < 0.1 mm Max. amount 0.1 mg/m 3 (class 1) Condensate: dew point < 3 C (class 4) Oil < 0.01 mg/m 3 (class 1) Germs (class 0) Water Water supply pressure (barg) Connection hose coupling, external d 10 mm d 10 mm Cooling water () () (for heating cooling system only) Temperature min. 4 min. 4 Degree of hardness max. 12 dh max. 12 dh Operative Environment Ambient temperature 0-40 C Relative humidity range 50 (40 C) 80 % (31 C)

9 Characteristics of the System Dimensions W + H + D (mm) BIOSTAT RM 20 complete Weight (kg) Material Bag holder Stainless steel, ABS Lid ABS BIOSTAT RM 50 complete Bag holder Stainless steel, ABS Lid ABS Load cells for BIOSTAT RM Stainless steel, ABS Control Tower Single Twin Stainless steel AISI 304 BIOSTAT RM Stainless steel

10 Process Control BIOSTAT RM BIOSTAT RM with Control Tower BIOSTAT RM 200 Temperature Module Heating Only - Electrical Heating Plates Temperature control RT-40 C RT-40 C RT-40 C Heating capacity W (48 V) W (48 V) W Heating Cooling (Option) - Open Thermostat System with Circulation Pump and Automatic Cooling Water Valve Temperature control 8 C above cooling water up to 40 C (8 C above cooling water up to 40 C) Heating capacity W W Over temperature protection Gassing Module Rocker - Optional Max. total flow (ml/min) One bag: lpm Controlled by MFC Twin bag: lpm Fixed CO 2 gassing (%) measured ± 5 % by IR sensor Internal air pump () Gassing Module Control Tower 4-Gas mix (O 2, N 2, CO 2, air) with headspace outlet Rotameters max. 4 max. 4 flow rates lpm 8.3 lpm lpm 36 lpm precision of rotameters ± 5 % FS ± 5 % FS MFC (optional) max. 4 max. 4 flow rates lpm 5 lpm 0.06 lpm 20 lpm precision of MFC ± 1 % FS ± 1 % FS 4-stage DO cascade Advanced DO controller () Sensors & Measurement Temperature probe Pt 100 temperature range C C C display resolution 0.1 C 0.1 C 0.1 C amplifiers 2 1(single)/2(twin) 2 ph single use measurement range display resolution 0.1 ph 0.1 ph amplifiers 1 (single) 2 (twin) 2 recalibration function DO single-use measurement range % % display resolution 0.1 % 0.1 % amplifiers 1 (single) 2 (twin) 2 recalibration function ViaMass online biomass Load cells () () () weight range accuracy max. 30 kg 10 g max. 30 kg/10 g Balance substrate (up to 2) per side (up to 2) per side External signal input max V or 4 20 ma 2

11 Pump Module BIOSTAT RM with Control Tower max. 4 internal and 2 external pumps, thereof 3 speed controlled per side Built-in Pumps Fixed Speed Watson Marlow 114, easy load pump head Speed 5 rpm Flow rate (tubing wall thickness 1.6 mm) Speed 44 rpm Flow rate (tubing wall thickness 1.6 mm) Speed Controlled Speed rpm Flow rate (tubing wall thickness 1.6 mm) Speed rpm Flow rate (tubing wall thickness 1.6 mm) External Pumps Speed Controlled BIOSTAT RM 200 Built-in Pumps Fixed Speed WM Speed Controlled WM 102 (2) External Pumps (via Analogue OUT) Speed Controlled (up to 2) ID: 0.5 mm: ml/min ID: 0.8 mm: ml/min ID: 1.6 mm: ml/min ID: 2.4 mm: ml/min ID: 3.2 mm: ml/min ID: 4.8 mm: ml/mi ID: 0.5 mm: ml/min ID: 0.8 mm: ml/min ID: 1.6 mm: ml/min ID: 2.4 mm: ml/min ID: 3.2 mm: ml/min ID: 4.8 mm: ml/min Watson Marlow 114, easy load pump head ID: 0.5 mm: ml/min ID: 0.8 mm: ml/min ID: 1.6 mm: ml/min ID: 2.4 mm: ml/min ID: 3.2 mm: ml/min ID: 4.8 mm: ml/min ID: 0.5 mm: ml/min ID: 0.8 mm: ml/min ID: 1.6 mm: ml/min ID: 2.4 mm: ml/min ID: 3.2 mm: ml/min ID: 4.8 mm: ml/min Watson Marlow 120, easy load pump head, up to 200 rpm Watson Marlow 323

12 Communication BIOSTAT RM BIOSTAT RM with Control Tower RS Industrial Ethernet (1) 1 1 Profibus DB (1) Analogue IN 2 2 Analogue OUT 2 2 BIOSTAT RM 200 The BIOSTAT RM rocker is designed to communicate with industrial controllers through the optional ethernet or Profibus DB interfaces. The device is supplied with an I/O protocol, while programming of the interfaces on the industrial controllers is performed by the customer.

13 Technical Data BIOSTAT RM BIOSTAT RM with Control Tower Max. total volume (L) Working volume (L) BIOSTAT RM 200 Rocking rate (r/min) 8 42 ± ± ± 1 Rocking angle ( ) 4 10 ± ± ± 0.3 Clamping rails for bag fixation Sensor clamps for secure fixation of 2 (single) 4 (twin) 4 glass fiber cables Filter heater 2 1 (single) 2 (twin) 2 Integrated controller BIOSTAT B controller Color touch screen Potential-free alarm contact (max. 0.5 A) () Safety measurement and shut-off 30 mbar (in combination 30 mbar 50 mbar with gassing module) Additional safety valve gasses (mbar) 100 mbar 100 mbar Water inlet pressure reduction value 1.5 bar, integrated pressure control Different user level log in () () Logbook function () ()

14 Sales and Service Contacts For further contacts, visit Europe 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 Les Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Sartorius Stedim France SAS ZI Les 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 Uralskaya str. 4, Lit. B , Saint-Petersburg Phone Fax Spain Sartorius Stedim Spain SA C/Isabel Colbrand 10, Oficina 70 Polígono Industrial de Fuencarral 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 America 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 Sartorius Stedim Biotech (Beijing) Co. Ltd. No. 33 Yu an Road Airport Industrial Park Zone B Shunyi District, Beijing Phone Fax Sartorius Stedim Biotech (Beijing) Co. Ltd. Shanghai Branch Office 3rd Floor, North Wing, Tower 1 No Jin Ke Road Pudong District, Shanghai 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 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 Specifications subject to change without notice. Printed in the EU on paper bleached without chlorine. W Publication No.: SBT1501-e Order No.: Ver