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ÄKTA avant Inspired to Äccelerate your process development Anna Emilsson Global Product Manager

ÄKTA avant - ebiotrade.com avant customer...50 and 70 on ÄKTA avant 150 • User guidance in UNICORN

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ÄKTA™avantInspired

to Äccelerate

your

process development

Anna Emilsson

Global Product Manager

2 /GE /

Version2.0

Evolution of ÄKTA™

1996 -

2010

1996 -

ÄKTAexplorer™

1997 -

ÄKTApurifier™

1998 –

ÄKTAFPLC™

1999 -

ÄKTAprime™

2000 –

ÄKTA OligoPilot

2001 –

ÄKTA add on´s

2002 –

ÄKTA Crystal and ÄKTApilot™

2004 -

ÄKTAxpress™

2005 –

ÄKTAcrossflow™

2006 –

New ÄKTApurifier

2009 -

ÄKTAmicro™

2009/10 ÄKTA avant

1982 –

FPLC ™

and Mono Q/S

3 /GE 28-9577-83 /

Version 4.0

Introducing the next generation of ÄKTA™Within biopharmaceutical process development there are mounting pressures to constrain costs while overcoming increasingly tough competition, regulations, and guidelines. At the same time, your overriding goal is to achieve swift and secure handover of robust processes.

ÄKTA is the Swedish word for “true”

or “real”

ÄKTA systems are used by 100,000 researchers globally

ÄKTA avant is the result of meticulous research and close dialogue with you

Setting the new standard for fast and secure process development

4 /GE 28-9577-83 /

Version 4.0

ÄKTA avant 150ÄKTA™

avant 25

Screening in small columns•

Method optimization•

Challenging purifications•

Small amounts of sample•

High res. prep. purification•

Optimized for column size i.d. 5-16 mm

Scale-up process•

Robustness testing•

Trouble shooting (scale-down)

Fine-tuning of process•

Optimized for column size i.d. 10-50 mm

Two versions for maximized performance

5 /GE 28-9577-83 /

Version 4.0

A complete workflow for Process development

HTPD-

Media screening-

Condition screening

ÄKTA™

avant 25 ÄKTA avant 150 ÄKTApilot™

ÄKTA ready

ScreeningMethod optimizationColumn size i.d. 5-16 mm

Scale-up process Fine-tuningRobustness testingColumn size i.d. 10-50 mm

Scale-up optimized processSanitary designColumn sizes from i.d. 50 mm

PreDictor™

Predict Optimize Scale-up Produce

6 /GE 28-9577-83 /

Version 4.0

Inspired to be the icon of process development

Speed:

Achieving robust, well characterized processes consumes time. ÄKTA™

avant overcomes this, enabling quicker insight and allowing you to get more done in the same time frame.

Scalability:

ÄKTA avant enables you to achieve direct scalability while

systematically anticipating errors to prevent any negative impact on safety, consistency, or economy of the full-scale separation.

Security:

ÄKTA avant allows you to obtain reliable results while working in

a

compliant, error-free manner with complete sample security.

7 /GE 28-9577-83 /

Version 4.0

ÄKTA™

avantSetting the future industrial standard

Inspired

speed

Inspired

security

Inspired

scalability

8 /GE 28-9577-83 /

Version 4.0

SpeedÄKTA™

avant has the capacity to significantly shorten the process development time, allowing you to get your products to the market faster

Maximum information, minimum experiments

with DoE

Automation with BufferPro

Ease-of-use with Method editor

9 /GE 28-9577-83 /

Version 4.0

Design of ExperimentsDoE

is an organized, statistical approach that varies multiple factors simultaneously significantly reducing the number of experiments required. The model is validated, used

to predict the response to untested factor settings, and produces tools to facilitate decision making

10 /GE 28-9577-83 /

Version 4.0

DoE

reduces your costDesign of Experiments allows the maximum amount of information to be obtained from a minimum number of experiments. By improving efficiency, both time and money are saved

Design of Experiments (DoE) is integrated in UNICORN™

6

Reach the same result in 16-32 experiments as you would with 128 experiments using the traditional approach!

DoE

Structured approach

Traditional approach

11 /GE 28-9577-83 /

Version 4.0

BufferPro

Automatic buffer preparationÄKTA™

avant includes BufferPro, truly automated on-line buffer preparation -

saves 30 min per buffer and pH-value!

Completely automated, advanced on-

line buffer preparation

Buffers are made in analogy with manual preparation: corresponding acids or bases used for pH adjustment

Actual mixing ratios and buffer recipes are provided

Allows for easy and quick pH-scouting

pH 5.5pH 5.4pH 5.3

16 pH steps 0.1 units apart,

with no manual buffer titration at all!

HiScreen™

Capto™

SpH from 4,0 to 5,5 using

the CIEX mix buffer

12 /GE 28-9577-83 /

Version 4.0

Increased ease of use in UNICORN™UNICORN 6 includes a new Method Editor, replacing the method wizard. No new text programming is required, new components immediately ready -

save a day’s work!

Contains all instructions used for controlling the chromatographic run

New user interface for easy viewing and editing of run properties

Use pre-defined methods / phases or program your own

Easy and flexible method creation -

Drag and drop from the phase library

Automatic calculation of volume, pressure and flow rate settings for columns

13 /GE 28-9577-83 /

Version 4.0

System & sample pumps set up to save timeÄKTA™

avant sample and system pumps have the same technical design and run independently, no re-plumbing is necessary, -

save a day’s work per week!

Save time on …

Column cleaning

Equilibration

Regeneration

Injection valve configuration

pH measurement in/out of line

Flow restrictor in/out of line

Software reprogramming

14 /GE 28-9577-83 /

Version 4.0

ÄKTA™

avantSetting the future industrial standard

Inspired

speed

Inspired

security

Inspired

scalability

15 /GE 28-9577-83 /

Version 4.0

ScalabilityÄKTA™

avant ensures smooth transition from product discovery to production through direct, reliable scalability using the same media

UNICORN™

6 -

A higher standard of intelligence.

Exploit the advantages of modern BioProcess™

media

Scalability from start to finish

16 /GE 28-9577-83 /

Version 4.0

Increase your productivity with high flow mediaÄKTA™

avant has flow rate and pressure specifications that support modern, high flow BioProcess™

media such as MabSelect™

and Capto™, allowing for smooth scale-up

Direct scalability to process scale, using the same media

Increased productivity with high dynamic binding capacity at high flow

Increased yield with rapid mass transfer

Reduced process time with high volume throughput

Cost-effective processing

Full support of modern media…Screening, column id 5-16 mm: 20-25 ml/minScale-up, columns id 16-50 mm: 120-130 ml/min

17 /GE 28-9577-83 /

Version 4.0

0

0,5

1

1,5

2

2,5

3

0 20 40 60 80 100 120 140 160

Flow rate (ml/min)

Back

pre

ssur

e (M

Pa)

ÄKTATM

avant

150 offers higher flow rates and lower back pressure than ÄKTAexplorer

100

No need for re-plumbing when changing application

Perfect fit with modern BioProcessTM

media

Any application without re-plumbingÄKTA avant

allows higher flow rates and lower back pressure, supporting modern BioProcess

media

ÄKTAexplorerTM

100

ÄKTA avant 150

18 /GE 28-9577-83 /

Version 4.0

Save time with automatic conversion of methods between different

scales

Quick and easy rescaling between ÄKTA™

avant 25 and 150

Automatic adjustment of system specific settings

Seamless scalability in UNICORN™

6

19 /GE 28-9577-83 /

Version 4.0

Dedicated column formats for method screeningUse HiScreen™

pre-packed columns -

save a day’s work and make scale up easy!

Save time on packing , preparation of gel, hardware and solutions, column testing and possible re-packing

Easily connected in series

Scalable to BioProcess™ columns packed with the same media using the same process fluid velocities

19 different BioProcess

media available

10 cm bed height -

ideal for method optimization and parameter screening

Reliable, reproducible and easy to use!

20 /GE 28-9577-83 /

Version 4.0

Pressure stable empty columnsPressure stable HiScale™

columns are compatible with modern BioProcess media

Pressure stable up to 20 bar (2 MPa)

Complements the XK column series –

equivalent wet parts

Available with three different inner diameters (16, 26 and 50 mm) and two different lengths (20 and 40 cm)

Double flow for column packing on ÄKTA™

avant 25 and 150 (50 and 300 ml/min)

Robust, intuitive design and easy to use!

21 /GE 28-9577-83 /

Version 4.0

Predictable scale up to production scaleReproducible column packing and convenient scale-up with ÄKTA™

avant 150 and AxiChrom™

The AxiChrom

column platform simplifies column handling at scales from process development to full-scale production

Intelligent Packing of AxiChromTM

50 and 70 on ÄKTA avant 150

User guidance in UNICORN™

6 ensures optimally packed beds and decreases user dependence

Process chromatography is made easier, safer and more efficient!

22 /GE 28-9577-83 /

Version 4.0

ÄKTA™

avantSetting the future industrial standard

Inspired

speed

Inspired

security

Inspired

scalability

23 /GE 28-9577-83 /

Version 4.0

SecurityÄKTA™

avant incorporates cutting-edge functionality critical to achieving real security throughout the development process

Cooled fraction collector for true sample integrity

Reliable column protection with

differential pressure measurement

UniTag scanning for complete traceability

24 /GE 28-9577-83 /

Version 4.0

Fraction collector for optimal securityHassle-free overnight running, outstanding reproducibility and sample security!

Temperature control (6

to 20°C) allows samples to be cooled and protected

Cassettes and rack trays available for micro titer plates up to 250 ml bottles

Load up to six cassettes in any combination

Automatic detection of tube rack type

Spill-free fractionation

25 /GE 28-9577-83 /

Version 4.0

Precolumn

pressure and delta pressure (ΔP) For increased operational safety, the pressure difference over the packed media bed (ΔP) is continuously measured

Pressure sensors integrated into the column valve

Before the column to protect column hardware

After the column, the pressure difference is calculated over the packed media bed (ΔP)

Automatic pressure-flow control to prevent overpressure

Pressure sensors are also connected to the system and sample pumps

26 /GE 28-9577-83 /

Version 4.0

Column handling optimized for sample securityRemove the risk of failed runs due to column performance, lifetime expiry &/or misuse, by keeping track of the columns with the Column Logbook and UniTag

labels

Identification -

Column type and ID identified through matrix code

Traceability -

View column data and run history

Security -

Set limits for different parameters e.g. allowed number of runs between CIP or Column Performance Test

Easy identification, automatic traceability and outstanding

security of operation!

27 /GE 28-9577-83 /

Version 4.0

ÄKTA™

avantSetting the future industrial standard

Inspired

technology

28 /GE 28-9577-83 /

Version 4.0

System orientation

Interactive instrumentdisplay delivers realtimeinformation.

Buffer tray for convenient,large capacity storage.

One wet side with modular set-up limits service down-time

Column valve with built-in by-pass and flow direction change.

High precision systempumps with integratedair sensors.

Swivel foot for easy accessto all parts of the instrument.

Cooled,built-in fractioncollector preventslocal heating ofsamples.

Automatic sample applicationwithout re-plumbing.

pH valve with built-in positions for pH calibration and storage.

29 /GE 28-9577-83 /

Version 4.0

Innovative setup and componentsMinimized down time during service with easily accessible front

mounted units

One wet working area easily accessed by simply by rotating the unit

Components have same geometry, the modules can be quickly exchanged

Cabinet with easy access

UV Monitor Mixer

Mixer sizes 0.6, 1.4 and 5 ml

Integrated in-line filter

No optical fibers accessible eliminating risk of damage -

increased safety

Easy to change flow cells: 2 and 10 mm

True optical path length identified automatically

Multi-functional units

Instrument Display

5,7”

TFT touch screen display

Shows selected run data

Has pause/continue functionality

Optional Components

Up to 3 extra valves

Extra air sensor (before sample pump or before column)

30 /GE 28-9577-83 /

Version 4.0

Sophisticated valve designCompletely redesigned valves -

versatile system setup for easy method development

Increased productivity and yield is obtained with the column valve: it connects up to 5 different columns and has built-in reversed flow functionality

Valve w. integrated pH-electrode enables easy calibration and automatic by-pass of electrode

Injection Valve

pH Valve (& Monitor)

Column Valves•

Multiple sample application techniques without re-plumbing

System pump and Sample pump can be run simultaneously

Up to five column positions

Built-in bypass position

Built-in flow direction change (reversed flow)

Built-in pressure sensors before and after column

Built-in bypass of pH flow cell

Built-in positions for pH calibration and storage

Built-in bypass of flow restrictor

Multi-functional units

Inlet Valves•

Built-in air sensor useable with all inlets Outlet Valve

Waste and Frac

positions

Up to 10 outlet positions

31 /GE 28-9577-83 /

Version 4.0

ÄKTA™

avant

Shorten process time with modern resins

Save 1 day’s work with easy and flexible method creation and reduce learning time to less than half!

Apply DoE

to significantly reduce your development costs

Save 30 min per buffer and pH value with BufferPro

Save 1 day’s work with system & sample pump set up to run independently & with no need for re-plumbing

Save 1 day’s work with pre-packed columns

Limited service down-time with easily accessible wet side & modular set up

Save time by running safely over night

Reducing weeks to days…

while giving you outstanding scalability and sample security

32 /GE /

Version 4.0

GE Healthcare Ltd, a General Electric Company. GE, imagination at work and GE Monogram are trademarks of General Electric Company.

ÄKTA, ÄKTAavant, ÄKTAexplorer, ÄKTApilot, BioProcess, MabSelect, MabSelect

SuRe, Capto, HiScreen, HiScale, AxiChromand UNICORN are trademarks of GE Healthcare companies.

“MabSelect

SuRe

Ligand

Restricted License”

and “Cys-rProtein

A Ligand

Restricted License”

are protected by the following patents and equivalent patents and patent applications in other countries: US 5,151,350, US 5,143,844, US 6,399,750, WO 03/00475and EP 1123389. A free, non-transferable limited license to use this product for internal analytical purposes only accompanies the purchase of the product from a GE Healthcare company and its

licensed distributors. Any other use will require a separatelicense from a GE Healthcare company.

All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. General Electric Company reserves the right, subject to anyregulatory and contractual approval, if required, to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation.

© 2010 General Electric Company –

All rights reserved.

GE Healthcare Bio-Sciences AB, a General Electric Company.

GE Healthcare Bio-Sciences AB, Björkgatan

30, SE-751 84 Uppsala, Sweden.