We Know Bioprocessing
Transcription
We Know Bioprocessing
We Know Bioprocessing Fermentors and bioreactors for research through production »Bioprocessing is at the heart of many industries and Eppendorf has the right solutions for all of them.« 3 Perfect Mix Joint expertise for excellent solutions Already well established as a global leader for liquid-, cell- and sample- handling products, Eppendorf entered the bioprocess market in 2007 through the acquisition of New Brunswick™ Scientific. This strategic move not only added 70 years of New Brunswick experience with autoclavable and sterilizable-in-place fermentors and bioreactors, it also allowed Eppendorf to add an array of lab products such as shakers, freezers, and incubators to its already comprehensive portfolio of products. In 2012, Eppendorf further expanded its bioprocess expertise and product offerings by acquiring DASGIP®, a Scalable systems > Eppendorf bioprocess systems cover a wide range of working volumes for applications from research through production pioneer in the development and production of benchtop and small scale parallel bioreactors, and information technology (IT) systems. Ideally-suited for high throughput and process development work, the DASGIP portfolio further expanded the Eppendorf bioprocess portfolio. With a comprehensive offering of single-use and traditional products for the growth of mammalian, microbial, insect, plant and algae cells, and working volumes of 60 mL – 2,400 L, the Eppendorf bioprocess portfolio can satisfy the demands of process development through production. Single-use options > Innovative single-use vessels feature traditional stirred tank design Software solutions > Comprehensive software packages offer innovative solutions for advanced process control and information management 4 A New Scale of Bioprocessing »Solutions that grow with you.« From the parallel mini bioreactor system for early stage bioprocess development, the benchtop and parallel bioreactor systems for the laboratory scale to the sterilize-in-place solutions for production: Eppendorf offers users from industry and research extensive bioprocess solutions from a single source and meets the highest quality demands. Parallel benchtop systems Mini bioreactor systems 60 - 250 mL Small scale 0.2 L - 2 L 0.7 - 3.8 L Bench scale 5 Benchtop bioreactors and fermentors 0.4 - 10 L 1.3 - 40 L Pilot scale SIP bioreactors and fermentors 5.5 - 2,400 L Production scale 6 DASbox® Mini Bioreactor System Small Scale Parallel Bioreactor Systems Bench Scale Parallel Bioreactor Systems CelliGen BLU BioFlo® / CelliGen 115 60 - 250 mL 0.2 - 2 L 0.7 - 3.8 L 1.3 - 40 L 0.4 - 10.5 L Single-use vessels available • • • • • Glass vessels, autoclavable • • • Interchangeable vessels • • • Bacteria/yeasts/fungi • • • • Plant cells/algae • • • • Mammalian/animal cells • • • • • Stem cells • • • • • Insect cells • • • • • Up to 24 Up to 16 Up to 16 DWC DWC DWC Working volume range1 ® • Stainless-steel vessels, SIP Number of parallel units Controller2 • • Up to 3 RPC RPC Touchscreen controller • • BioCommand • • ® DASware® • • • • • 4 gas (air, N2, O2, CO2) 4 gas (air, N2, O2, CO2) 4 gas (air, N2, O2, CO2) 4 gas (air, N2, O2, CO2) 4 gas (air, N2, O2, CO2) TMFC R or TMFC R or TMFC R4 or TMFC R or TMFC Exhaust analysis • • • • • Optical density measurement • • • Gas mixing options Gas flow control3 Validation Realized using multiple vessels Controllers: DWC=DASware control, RPC=Reactor Process Controller, BCS=BioFlo Control Software, PLC=Programmable Logic Controller Gas Flow Controllers: R=Rotameter, TMFC=Thermal Mass Flow Controller 4 Rotameter is for overlay only 1 2 3 • • 7 BioFlo 320 BioFlo 415 BioFlo 510 CelliGen 510 BioFlo 610 BioFlo Pro CelliGen Pro 0.25 - 40 L 2.0 -15.5 L 5.5 - 32 L 5.5 - 32 L 13 - 100 L 32 - 2400 L 18.8 - 520 L • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Up to 8 BCS RPC RPC/PLC RPC/PLC RPC PLC PLC • • • • • • • • • • • • • • • • 4 gas (air, N2, O2, CO2) 4 gas (air, N2, O2, CO2) 4 gas (air, N2, O2, CO2) 4 gas (air, N2, O2, CO2) 2 gas (air, O2) 2 gas (air, O2) 4 gas (air, N2, O2, CO2) TMFC R or TMFC R or TMFC R or TMFC R or TMFC R or TMFC R or TMFC • • • • • • • • • • • • • • • 8 Parallel Bioprocessing for Unparalleled Results DASGIP® Bioreactor Systems DASbox Parallel mini bioreactor system 60 - 250 mL working volume > 4-fold parallel system extendable to up to 24 parallel operated glass or single-use bioreactors > Suitable for cell culture and microbial fermentation > Compact mini bioreactor system: requires only 7 cm (3 inches) bench space per bioreactor > Optimal tool for DoE and scale down approaches > Agitation control supporting overhead-driven Rushton, marine-type or pitched blade impellers > Innovative liquid-free temperature control system needs no coolant agent supply and supports independent temperature control for each bioreactor > Accurate monitoring and control of pH, DO and level > Variable speed pumps for accurate liquid addition and operation in batch, fed-batch, continuous and cyclic perfusion mode > 4 mass flow controllers per bioreactor allow for individual mixing of air, N2, O2 and CO2 to headspace and/or submerged > Novel liquid-free Peltier exhaust condenser with easy to handle slide in - slide out activation and deactivation > DASware control Software for advanced process control > Compatible with DASware® Software Suite for interconnectivity and bioprocess information management DASGIP Parallel Bioreactor Systems for small-scale applications 0.2 - 2 L working volume > Parallel operation of up to 16 glass or single-use bioreactors > DASGIP Bioblock for advanced and user-friendly temperature control > Suitable for cell culture, microbial fermentation and phototrophic cultivation > Modular design of control units allows for flexible system configurations that meet the demands of specific applications > Control of agitation, pH, level and DO (including customizable cascade modes) in each bioreactor > Variable speed pumps for accurate liquid addition and operation in batch, fed-batch, continuous and cyclic perfusion mode > Optical absorbance measurement for online calculation of e.g. OD600 or cell dry weight > TMFC individual gas mixing of air, N2, O2 and CO2 > Online calculation of OTR, CTR and RQ > DASware control Software for advanced process control > Compatible with DASware Software Suite for interconnectivity and bioprocess information management 9 Choice of impellers DASGIP PBR4 for phototropic cultivation DASGIP Parallel Bioreactor Systems for bench-scale applications 0.7 - 3.8 L working volume > Parallel operation of up to 16 glass or single-use bioreactors > Suitable for cell culture, microbial fermentation and phototrophic cultivation > Modular design of control units for flexible system configurations that meet the demands of specific applications > Temperature control via heating blankets and cooling fingers > Control of agitation, pH, level and DO (including customizable cascade modes) in each bioreactor > Variable speed pumps for accurate liquid addition and operation in batch, fed-batch, continuous and cyclic perfusion mode > Optical absorbance measurement for online calculation of e.g. OD600 or cell dry weight > TMFC individual gas mixing of air, N2, O2 and CO2 > Online calculation of OTR, CTR and RQ > DASware control Software for advanced process control > Compatible with DASware Software Suite for interconnectivity and bioprocess information management DASGIP Peltier Exhaust Condensors for selected glass and single-use vessels DASGIP Compression Fittings for headplate ports 10 Exceedingly Versatile — Bench Scale Fermentors and Bioreactors New Brunswick CelliGen BLU Bench-scale single-use bioreactor 1.3 - 40 L working volume > Designed for high-density cell culture in research or production applications > Rigid-walled, single-use stirred-tank vessel for proven performance and scalability > Eliminates vessel autoclaving and cleaning > All vessel components in product contact are made of USP Class VI materials and tested for leachables and extractables > Packed-bed vessel: first single-use vessel to feature proprietary New Brunswick Fibra-Cel® and packedbed impeller > Features intuitive New Brunswick RPC control software and touchscreen interface > Non-invasive pH and DO technology > Validation packages available > Seven additional analog input/output connections for local integration of ancillary equipment > Compatible with DASware Software Suite or BioCommand for bioprocess information management New Brunswick BioFlo/CelliGen 115 Bench-scale fermentor/bioreactor 0.4 - 10.5 L working volume > Precise temperature control provided through heat blanketed vessel (shown above) or water jacketed vessel > Compatible BioBLU single-use vessels > Pre-programmed with both fermentation and cell culture operating modes for flexibility > Ability to control up to three independent reactors from a single easy-to-use touchscreen > Features intuitive New Brunswick RPC control software and touchscreen interface > Eight interchangeable glass vessel options > Customizable gas flow and mixing options > Available in pre-defined packages for easy ordering, or fully configurable systems to meet specific needs > Compatible with DASware Software Suite or BioCommand for bioprocess information management 11 BioFlo 320 Bench-scale fermentor and bioreactor 0.6 - 10.5 L working volume (autoclavable) 0.25 - 40 L working volume (single-use) > Interchangeable autoclavable and BioBLU Single-Use Vessels > Integrated Mettler Toledo® Intelligent Sensor Management (ISM) platform > Control up to eight systems from a single-user interface > Universal control for both microbial and cell culture applications > Field-upgradable TMFC drawers for sparge and overlay gas > Enhanced software package with new cascade and time profile features > Built-in optical pH sensing technology for use with the BioBLU Single-Use Vessels > Ethernet communication for multi-unit control, Eppendorf SCADA software, and IP addressing > Up to six integrated pumps capable of operating in variable speed mode > Eight independently controlled process gas supplies > Suitable for batch, fed batch, and continuous processes > Validation packages available for GMP regulated processes New Brunswick BioFlo 415 Bench-scale fermentor 2.0 - 15.5 L working volume > Automated SIP process utilizes only a water supply and the system’s built-in electric heat blanket for sterilization - no external steam supply needed > Eliminates the need for transferring vessels to the autoclave for sterilization > Features intuitive New Brunswick RPC control software and touchscreen interface > Fully customizable trend screen for data logging > User-definable cascades for localized process control > Validation packages available > 7 additional analog input/output connections for local integration of ancillary equipment > ASME-rated pressure vessel > Compatible with DASware Software Suite or BioCommand for bioprocess information management 12 Industry Standards meet Flexibility — Sterilizable-in-Place Fermentors and Bioreactors New Brunswick BioFlo 510 & CelliGen 510 Bench- and pilot-scale SIP fermentor and bioreactor 5.5 - 32 L working volume New Brunswick BioFlo 610 Pilot-scale SIP fermentor 13 - 100 L working volume > SIP bench and pilot scale reactors designed to meet the needs of R&D through production > Modular design allows for complete system flexibility > Add or remove components pre- or post-delivery > Multiple impeller and gas flow options > Features intuitive New Brunswick RPC control software and touchscreen interface > Optional Allen Bradley® PLC > Integrated load cell for online vessel volume monitoring > Fully automated SIP sequence for sterilization > Validation packages available > 7 additional analog input/output connections for local integration of ancillary equipment > ASME-rated pressure vessel > Integrated mobile skid simplifies transport > Pilot production system without the traditional cost or footprint > Modular design allows for complete system flexibility > Features intuitive New Brunswick RPC control software and touchscreen interface > Fully integrated load cell for online vessel volume monitoring > Validation packages available > 7 additional analog input/output connections for local integration of ancillary equipment > ASME-rated pressure vessel 13 1 New Brunswick BioFlo Pro & CelliGen Pro Large-scale SIP fermentor and bioreactor BioFlo Pro: 32 - 2,400 L working volume CelliGen Pro: 18.8 - 520 L working volume > Large scale industrial system with full adherence to cGMP and GAMP® guidelines > Modular design with over a hundred options allows for high level of customization pre and post delivery > Multiple validation package offerings > Open piping skid allows for easy accessibility > NEMA-4 (IP65) rated control cabinet with industrystandard Allen Bradley PLC > Flush mounted vessel ports for enhanced vessel design and drainability > Multiple impeller and gas flow options > Optional validation packages available > ASME-rated pressure vessel 2 3 4 5 Eppendorf offers a diverse range of specialized impellers for New Brunswick bioreactors including: 1. Spin Filter (shown with marine blade impeller) 2. Cell-Lift Impeller 3. Packed-Bed Basket Impeller with draft tube for use with Fibra-Cel® disks (complete impeller assembly shown below) 4. Pitched Blade Impeller 5. Marine Blade Impeller Rushton and Rushton-type Impellers (not shown) Impellers and Fibra-Cel disk options enhance growth and productivity Fibra-Cel disks are a solid support material used with New Brunswick packed-bed bioreactors for growth of adherent mammalian, animal and insect cells, when secreted proteins are desired. Key advantages: > Cell densities averaging 10 times higher than traditional microcarriers, due to protection from shear forces > Higher mass transfer of nutrients and oxygen > Low pressure drop across the bed for efficient scale-up > Higher surface-to-volume ratios 14 BioBLU® Single-Use Vessels — Dependability through Proven Design From 65 mL to 40 L, working volume, Eppendorf has a single-use solution to meet your needs Single-use simplicity With renowned polymer expertise, Eppendorf is proud to offer the largest portfolio of rigid walled stirred-tank singleuse vessels – in small and bench scale, to be operated with parallel DASbox Mini Bioreactor System, DASGIP Parallel Bioreactor Systems, or New Brunswick bench scale systems. Kits are also available for third-party bioprocess systems. They are easy to install and compatible with popular Applikon® and Sartorius® autoclavable bioprocessing systems. Benefits > Proven performance and scalability of stirred-tank design > User-friendly set-up for rapid turnaround, shorter development times and lower operating costs > Specifically adapted designs available for microbial applications > Packed-bed configuration with Fibra-Cel disks is ideal for perfusion/continuous processes > USP Class VI and animal component-free materials, making vessels appropriate for GMP production > Non-invasive or industry standard sensor technology 15 Single-use for DASbox. Choice of BioBLU 0.3 mini vessels for cell culture and microbial applications. With small working volumes from 65 to 250 mL perfectly suited for DoE appoaches. Single-use for DASGIP Bioblock. Choice of BioBLU 1 vessels for cell culture and microbial application, designed for truly parallel bioprocessing. Working volume range from 0.25 to 1.25 L. Single-use for Eppendorf and thirdparty bioreactor controller. BioBLU 5c, BioBLU 14c and BioBLU 50c for best scalability in cell culture. Working volume range from 1.3 to 40 L. Single-use for DASGIP Parallel Bioreactor Systems. Parallel processing with BioBLU 5c and BioBLU 14c vessels for best scalability with processes developed in DASbox or DASGIP Bioblock. BioBLU 5p vessel for adherent cells and perfusion processes. Packed-bed vessels utilizing the proprietary Eppendorf packedbed impeller design with pre-loaded FibraCel disks. BioBLU 0.3f and BioBLU 1f vessels fully address the specific needs of fermentation, including mass and heat transfer. Working volume range of 65 mL to 1.25 L. 16 Eppendorf Bioprocess Software — Much More Than Just Bioprocess Control Eppendorf bioprocess software solutions - advanced monitoring and control through comprehensive information management Eppendorf offers BioCommand® and DASware control Supervisory Control and Data Acquisition (SCADA) software packages for advanced bioprocess control. Next-generation bioprocess management is provided by the comprehensive DASware software suite. BioCommand software Enhances your ability to monitor, control and log data from your fermentation and cell culture processes through your personal computer. Three distinct packages provide the tools needed for research, optimization, and if needed, the security and audit trails to meet your regulatory requirements. > Track and Trend: Provides the ability to trend and control parameter setpoints, establish alarm settings, and produce batch records; and is ideal for basic process management > Batch Control: Additional enhanced control features including a sophisticated programming module, custom synoptic display window, and equipment lock-out feature > Batch Control Plus: Includes three levels of security, event logs, and audit-trail capabilities to be compatible with the FDA 21 CFR Part 11 Features Batch info User-defined event log Summary Loop info Alarms Trend graphs Data log Reports Graphical programming Script programming Synoptic display Equipment lock-out Audit trail/security Track & Trend Batch Control • • • • • • • • • • • • • • • • • • • • Batch Control Plus • • • • • • • • • • • • DASware control • • • • • • • • • • • • • 21 CFR Part 11 • (•)* OPC compliance • • • • Parallel calibration • DASware compatibility • * 21 CFR Part 11 compatibility is available for DASware control as an optional package. Please contact us for further information. 17 DASware control software Is at the core of all DASbox and DASGIP systems and was designed for parallel cultivation with individual control of each bioreactor. Parallel calibration and cleaning procedures are supported as well as integrated batch functionality for process and recipe management. It features easy one-click start, configurable online charts, trending, logging rates and online configurable control parameters and profiles. Full controller scripting eases scale-up and scale-down. Automated data export, reporting and chart creation with Microsoft® Excel® add-in as well as professional database with managed access (Microsoft® SQL Server®) support advanced reporting and data processing. DASware analyze and DASware connect enable OPC client/server functionality. DASware® software suite Next-generation bioprocess management A suite of smart and flexible software solutions to accelerate bioprocess development. It enables interconnectivity of bioreactors with external lab-devices, comprehensive data- and information management, Design of Experiments (DoE) and remote control of bioprocesses. DASware can be used with any Eppendorf benchtop bioreactor solution as well as third-party bioreactor controllers. DASware access > Remote monitoring and control of bioprocesses via PC, Notebook and Netbook or with the DASGIP iApp via iPhone®, iPod touch® and iPad® DASware design > Applies the Design of Experiments (DoE) concept via a full factorial DoE builder or by importing DoE designs from third-party DoE tools DASware analyze > Seamless integration of external lab devices to the bioreactor allows for process automation and feedback control loops DASware discover > A comprehensive and user-friendly information management solution for bioprocessing DASware connect > Integration into process control systems and legacy corporate historians facilitating company-wide access to all relevant bioprocess data DASware migrate > Integration of various bioreactor control units and systems - this software is the gateway to comprehensive functionality of DASware on third-party bioreactor controllers 18 Eppendorf Life Science Solutions PCR cyclers Amplify target DNA with premium, reliable and reproducible results Electroporation & microinjection Comfortable manipulation of microbial, animal and human cells Centrifugation Outstanding ergonomic operation, superior temperature control and outstanding product quality CO2 incubators Support cGMP work, stem cell research, cancer research, as well as traditional cell culture Shakers Provide researchers with an easy-touse system for culturing cells built on a history of dependability Ultra-low temperature freezers Safe and energy efficient sample storage at -86 °C 19 Perfect Your Workflows Eppendorf — Your workflow oriented system supplier As a workflow oriented provider of lab equipment, Eppendorf offers instruments, consumables and accessories that perfectly fit your processes in the lab and thus your daily lab work. Our comprehensive solutions are engineered with smart innovations to simplify or even eliminate cumbersome lab work. You will find flexible solutions to prepare, handle, and analyze your samples and cells. >>Further workflows are available on www.eppendorf.com/workflows Workflows Antibody Production Biochemistry Biofuels Bioprocessing R&D Cell Biology Microbiology Molecular Biology Next Generation Sequencing Stem Cells ® In touch with life Your local distributor: www.eppendorf.com/contact Eppendorf AG · 22331 Hamburg · Germany [email protected] • www.eppendorf.com www.eppendorf.com Allen Bradley® is a registered trademark of Rockwell Automation, Inc., USA. Mettler Toledo® is a registered trademark of Mettler-Toledo AG, Switzerland. Applikon® is a registered trademark of Applikon, B.V. Corporation, Netherlands. iPhone®, iPad®, and iPod touch® are registered trademarks of Apple Inc., USA. GAMP® is a registered trademark of the International Society for Pharmaceutical Engineering, USA. Microsoft®, Excel®, and SQL Server® are a registered trademarks of Microsoft Corporation, USA. Sartorious® is a registered trademark of Sartorius AG, Germany. Fibra-Cel® is a registered trademark owned by Minerals California, Inc., USA and licensed to Eppendorf, Inc., USA. Eppendorf®, the Eppendorf logo, BioBLU®, and In touch with life® are registered trademarks of Eppendorf AG, Germany. New Brunswick™ is a trademark of Eppendorf AG, Germany. BioFlo®, CelliGen®, and BioCommand® are registered trademarks of Eppendorf, Inc., Enfield, Connecticut (USA). DASGIP®, DASbox®, and DASware® are registered trademarks of DASGIP Information and Process Technology GmbH, Germany. U.S. Design Patents are listed on www.eppendorf.com/ip. All rights reserved, including graphics and photos. Copyright © 2015 by Eppendorf AG Order no. A760 111 020/GB2/3T/0715/EBC/K&R · Carbon neutrally printed in Germany
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