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
eppendorf@eppendorf.com • 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