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

Transcription

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

2 Evolution of ÄKTA /10 ÄKTA avant ÄKTAmicro 2006 New ÄKTApurifier 2005 ÄKTAcrossflow ÄKTAxpress 2002 ÄKTA Crystal and ÄKTApilot 2001 ÄKTA add on s 2000 ÄKTA OligoPilot ÄKTAprime 1998 ÄKTAFPLC ÄKTApurifier ÄKTAexplorer 1982 FPLC and Mono Q/S 2/ GE / Version2.0

3 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 3/

4 Two versions for maximized performance ÄKTA avant 25 Screening in small columns Method optimization Challenging purifications Small amounts of sample High res. prep. purification Optimized for column size i.d mm ÄKTA avant 150 Scale-up process Robustness testing Trouble shooting (scale-down) Fine-tuning of process Optimized for column size i.d mm 4/

5 A complete workflow for Process development Predict Optimize Scale-up Produce PreDictor ÄKTA avant 25 ÄKTA avant 150 ÄKTApilot ÄKTA ready HTPD - Media screening - Condition screening Screening Method optimization Column size i.d mm Scale-up process Fine-tuning Robustness testing Column size i.d mm Scale-up optimized process Sanitary design Column sizes from i.d. 50 mm 5/

6 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. 6/

7 ÄKTA avant Setting the future industrial standard Inspired speed Inspired scalability Inspired security 7/

8 Speed ÄKTA 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 8/

9 Design of Experiments DoE 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 9/

10 DoE reduces your cost Design 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 experiments as you would with 128 experiments using the traditional approach! DoE Structured approach Traditional approach 10 /

11 BufferPro Automatic buffer preparation ÄKTA avant includes BufferPro, truly automated on-line buffer preparation - saves 30 min per buffer and ph-value! Completely automated, advanced online buffer preparation ph 5.5 ph 5.4 ph 5.3 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 HiScreen Capto S ph from 4,0 to 5,5 using the CIEX mix buffer 16 ph steps 0.1 units apart, with no manual buffer titration at all! 11 /

12 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 12 /

13 System & sample pumps set up to save time ÄKTA 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 13 /

14 ÄKTA avant Setting the future industrial standard Inspired speed Inspired scalability Inspired security 14 /

15 Scalability ÄKTA avant ensures smooth transition from product discovery to production through direct, reliable scalability using the same media Exploit the advantages of modern BioProcess media UNICORN 6 - A higher standard of intelligence. Scalability from start to finish 15 /

16 Increase your productivity with high flow media ÄKTA 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: ml/min Scale-up, columns id mm: ml/min 16 /

17 Any application without re-plumbing ÄKTA avant allows higher flow rates and lower back pressure, supporting modern BioProcess media 3 Back pressure (MPa) 2,5 2 1,5 1 ÄKTAexplorer TM 100 ÄKTA TM 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 BioProcess TM media 0,5 ÄKTA avant Flow rate (ml/min) 17 /

18 Seamless scalability in UNICORN 6 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 18 /

19 Dedicated column formats for method screening Use 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 10 cm bed height - ideal for method optimization and parameter screening Easily connected in series Scalable to BioProcess columns packed with the same media using the same process fluid velocities 19 different BioProcess media available Reliable, reproducible and easy to use! 19 /

20 Pressure stable empty columns Pressure 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! 20 /

21 Predictable scale up to production scale Reproducible 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 AxiChrom TM 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! 21 /

22 ÄKTA avant Setting the future industrial standard Inspired speed Inspired scalability Inspired security 22 /

23 Security ÄKTA 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 23 /

24 Fraction collector for optimal security Hassle-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 24 /

25 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 25 /

26 Column handling optimized for sample security Remove 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! 26 /

27 ÄKTA avant Setting the future industrial standard Inspired technology 27 /

28 System orientation Interactive instrument display delivers realtime information. Buffer tray for convenient, large capacity storage. One wet side with modular set-up limits service down-time Cooled, built-in fraction collector prevents local heating of samples. Column valve with built-in by-pass and flow direction change. ph valve with built-in positions for ph calibration and storage. Swivel foot for easy access to all parts of the instrument. Automatic sample application without re-plumbing. High precision system pumps with integrated air sensors. 28 /

29 Innovative setup and components Minimized 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 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 Instrument Display 5,7 TFT touch screen display Shows selected run data Has pause/continue functionality Mixer Mixer sizes 0.6, 1.4 and 5 ml Integrated in-line filter Optional Components Up to 3 extra valves Extra air sensor (before sample pump or before column) Multi-functional units 29 /

30 Sophisticated valve design Completely 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 Multiple sample application techniques without re-plumbing System pump and Sample pump can be run simultaneously ph Valve (& Monitor) Built-in bypass of ph flow cell Built-in positions for ph calibration and storage Built-in bypass of flow restrictor Inlet Valves Built-in air sensor useable with all inlets Column Valves Up to five column positions Built-in bypass position Built-in flow direction change (reversed flow) Built-in pressure sensors before and after column Outlet Valve Waste and Frac positions Up to 10 outlet positions Multi-functional units 30 /

31 ÄKTA avant Reducing weeks to days 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 while giving you outstanding scalability and sample security 31 /

32 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, AxiChrom and 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 03/00475 and EP 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 separate license 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 any regulatory 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 General Electric Company All rights reserved. GE Healthcare Bio-Sciences AB, a General Electric Company. GE Healthcare Bio-Sciences AB, Björkgatan 30, SE Uppsala, Sweden. 32 / GE /