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Fermentors and bioreactors for research through production We Know Bioprocessing

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Page 1: We Know Bioprocessing - Copybook · We Know Bioprocessing ... In 2012, Eppendorf further ... > Parallel operation of up to 16 glass or single-use bioreactors

Fermentors and bioreactors for research through production

We Know Bioprocessing

Page 2: We Know Bioprocessing - Copybook · We Know Bioprocessing ... In 2012, Eppendorf further ... > Parallel operation of up to 16 glass or single-use bioreactors

»Bioprocessing is at the heart of many industries and Eppendorf has the right solutions for all of them.«

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Perfect Mix

Joint expertise for excellent solutionsAlready 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 o�erings by acquiring DASGIP®, a

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 o�ering 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.

Scalable systems > Eppendorf bioprocess systems cover a wide range of working volumes for applications from research through production

Single-use options > Innovative single-use vessels feature traditional stirred tank design

Software solutions > Comprehensive software packages o�er innovative solutions for advanced process control and information management

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A New Scale of Bioprocessing

Small scale Bench scale

Mini bioreactor systems

60 - 250 mL 0.2 L - 2 L 0.7 - 3.8 L

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.

»Solutions that grow with you.«

Parallel benchtop systems

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A New Scale of Bioprocessing

Pilot scale Production scale

Benchtop bioreactors and fermentors SIP bioreactors and fermentors

0.4 - 10 L 1.3 - 40 L 5.5 - 2,400 L

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DASbox®

Mini Bioreactor System

Small Scale Parallel Bioreactor

Systems

Bench Scale Parallel Bioreactor

Systems CelliGen® BLUBioFlo® /

CelliGen 115 BioFlo 320 BioFlo 415 BioFlo 510 CelliGen 510 BioFlo 610 BioFlo Pro CelliGen Pro

Working volume range1

60 - 250 mL 0.2 - 2 L 0.7 - 3.8 L 1.3 - 40 L 0.4 - 10.5 L 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

Single-use vessels available• • • • • •

Glass vessels, autoclavable• • • • •

Stainless-steel vessels, SIP• • • • • •

Interchangeable vessels• • • • • • •

Bacteria/yeasts/fungi• • • • • • • • •

Plant cells/algae• • • • • • • • • • •

Mammalian/animal cells• • • • • • • •

Stem cells• • • • • • • •

Insect cells• • • • • • • • •

Number of parallel unitsUp to 24 Up to 16 Up to 16 Up to 3 Up to 8

Controller2

DWC DWC DWC RPC RPC BCS RPC RPC/PLC RPC/PLC RPC PLC PLC

Touchscreen controller• • • • • • • • •

BioCommand®

• • • • • • • • •DASware®

• • • • • • •Gas mixing options 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)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)

Gas flow control3

TMFC R or TMFC R or TMFC R4 or TMFC R or TMFC TMFC R or TMFC R or TMFC R or TMFC R or TMFC R or TMFC R or TMFC

Exhaust analysis• • • • • • • • • • • •

Optical density measurement• • • • •

Validation• • • • • • • •

1 Realized using multiple vessels2 Controllers: DWC=DASware control, RPC=Reactor Process Controller, BCS=BioFlo Control Software, PLC=Programmable Logic Controller 3 Gas Flow Controllers: R=Rotameter, TMFC=Thermal Mass Flow Controller4 Rotameter is for overlay only

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DASbox®

Mini Bioreactor System

Small Scale Parallel Bioreactor

Systems

Bench Scale Parallel Bioreactor

Systems CelliGen® BLUBioFlo® /

CelliGen 115 BioFlo 320 BioFlo 415 BioFlo 510 CelliGen 510 BioFlo 610 BioFlo Pro CelliGen Pro

Working volume range1

60 - 250 mL 0.2 - 2 L 0.7 - 3.8 L 1.3 - 40 L 0.4 - 10.5 L 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

Single-use vessels available• • • • • •

Glass vessels, autoclavable• • • • •

Stainless-steel vessels, SIP• • • • • •

Interchangeable vessels• • • • • • •

Bacteria/yeasts/fungi• • • • • • • • •

Plant cells/algae• • • • • • • • • • •

Mammalian/animal cells• • • • • • • •

Stem cells• • • • • • • •

Insect cells• • • • • • • • •

Number of parallel unitsUp to 24 Up to 16 Up to 16 Up to 3 Up to 8

Controller2

DWC DWC DWC RPC RPC BCS RPC RPC/PLC RPC/PLC RPC PLC PLC

Touchscreen controller• • • • • • • • •

BioCommand®

• • • • • • • • •DASware®

• • • • • • •Gas mixing options 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)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)

Gas flow control3

TMFC R or TMFC R or TMFC R4 or TMFC R or TMFC TMFC R or TMFC R or TMFC R or TMFC R or TMFC R or TMFC R or TMFC

Exhaust analysis• • • • • • • • • • • •

Optical density measurement• • • • •

Validation• • • • • • • •

1 Realized using multiple vessels2 Controllers: DWC=DASware control, RPC=Reactor Process Controller, BCS=BioFlo Control Software, PLC=Programmable Logic Controller 3 Gas Flow Controllers: R=Rotameter, TMFC=Thermal Mass Flow Controller4 Rotameter is for overlay only

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> 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

DASGIP Parallel Bioreactor Systems for small-scale applications0.2 - 2 L working volume

DASbox Parallel mini bioreactor system60 - 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

Parallel Bioprocessing for Unparalleled Results DASGIP® Bioreactor Systems

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> 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 Parallel Bioreactor Systems for bench-scale applications 0.7 - 3.8 L working volume

Choice of impellers

DASGIP PBR4for phototropic cultivation

DASGIP Peltier Exhaust Condensors for selected glass and single-use vessels

DASGIP Compression Fittings for headplate ports

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Exceedingly Versatile —Bench Scale Fermentors and Bioreactors

> 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 packed-bed 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

> 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

New Brunswick CelliGen BLU Bench-scale single-use bioreactor1.3 - 40 L working volume

New Brunswick BioFlo/CelliGen 115 Bench-scale fermentor/bioreactor0.4 - 10.5 L working volume

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> 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

> 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

BioFlo 320 Bench-scale fermentor and bioreactor0.6 - 10.5 L working volume (autoclavable)0.25 - 40 L working volume (single-use)

New Brunswick BioFlo 415 Bench-scale fermentor 2.0 - 15.5 L working volume

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Industry Standards meet Flexibility —Sterilizable-in-Place Fermentors and Bioreactors

> 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

New Brunswick BioFlo 610Pilot-scale SIP fermentor13 - 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

New Brunswick BioFlo 510 & CelliGen 510 Bench- and pilot-scale SIP fermentor and bioreactor5.5 - 32 L working volume

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1 2 3 4 5

13

> 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 o�erings > Open piping skid allows for easy accessibility > NEMA-4 (IP65) rated control cabinet with industry-standard 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

New Brunswick BioFlo Pro & CelliGen Pro Large-scale SIP fermentor and bioreactorBioFlo Pro: 32 - 2,400 L working volume CelliGen Pro: 18.8 - 520 L working volume

Eppendorf o�ers a diverse range of specialized impellers for New Brunswick bioreactors including:1. Spin Filter (shown with marine blade impeller)2. Cell-Lift Impeller3. Packed-Bed Basket Impeller with draft tube for use with

Fibra-Cel® disks (complete impeller assembly shown below)

4. Pitched Blade Impeller5. Marine Blade ImpellerRushton 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 e®cient scale-up > Higher surface-to-volume ratios

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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 simplicityWith renowned polymer expertise, Eppendorf is proud to o�er the largest portfolio of rigid walled stirred-tank single-use 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

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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 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.

Single-use for Eppendorf and third-

party 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 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.

BioBLU 5p vessel for adherent cells and

perfusion processes. Packed-bed vessels

utilizing the proprietary Eppendorf packed-

bed impeller design with pre-loaded Fibra-

Cel disks.

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Eppendorf Bioprocess Software —Much More Than Just Bioprocess Control

Eppendorf bioprocess software solutions - advanced monitoring and control through comprehensive information management

Eppendorf o�ers 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

Track & Trend

Batch Control

Batch Control

Plus

DASware control

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 • •

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.

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DASware control softwareIs 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 migrate > Integration of various bioreactor control units and systems - this software is the gateway to comprehensive functionality of DASware on third-party bioreactor controllers

DASware analyze > Seamless integration of external lab devices to the bioreactor allows for process automation and feedback control loops

DASware connect > Integration into process control systems and legacy corporate historians facilitating company-wide access to all relevant bioprocess data

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 discover > A comprehensive and user-friendly information management solution for bioprocessing

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Ultra-low temperature freezersSafe and energy e®cient sample storage at -86 °C

PCR cyclersAmplify 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 incubatorsSupport cGMP work, stem cell research, cancer research, as well as traditional cell culture

Shakers Provide researchers with an easy-to-use system for culturing cells built on a history of dependability

Eppendorf Life Science Solutions

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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.

Perfect Your Workflows

> Further workflows are available on www.eppendorf.com/workflows

WorkflowsAntibody ProductionBiochemistryBiofuels Bioprocessing R&DCell BiologyMicrobiologyMolecular BiologyNext Generation SequencingStem Cells

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In touch with life®

www.eppendorf.com

Your local distributor: www.eppendorf.com/contact Eppendorf AG · 22331 Hamburg · Germany [email protected] • 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