EcoPrime SMB. Simulated Moving Bed Chromatography By LEWA-Nikkiso featuring Bayer * technology. Technology enabling chiral separations - efficiently

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1 EcoPrime SMB Simulated Moving Bed Chromatography By LEWA-Nikkiso featuring Bayer * technology Technology enabling chiral separations - efficiently *patented technology licensed from Bayer AG

2 Separating two enantiomers The task of separating two enantiomers (identical structure but mirror image - right hand / left hand), can result in life-saving therapies. While challenging at the lab scale, in a continuous production environment this separation can be even more daunting. LEWA-Nikkiso, using the patented approach from Bayer AG, now has a solution for production scale. LEWA - Nikkiso Image: Wikipedia 2

3 New separation possibilities, cost effective The availability of this design has opened new possibilities and efficiencies for these daunting but important separations. LEWA-Nikkiso designs, automates and manufactures SMB systems that can swiftly separate chiral compounds at production scale. In 4 zones using 8 chromatography columns the LEWA Nikkiso technology deftly separates chiral compounds using columns and media of your choice. 3

4 Your choice in media and columns; our hardware, software and expertise. The LEWA EcoPrime SMB is scaleable and built for the GMP scale production of API s. LEWA Nikkiso Group Shown above: 5 cm column system 4

5 Open-loop concept reduces complexity, cost. Advantage of LEWA / BAYER AG* design: No internal recycling pump, thus longer life time of high flow rate pump and columns No need of a third high pressure inlet pump Symmetric SMB equipment design LEWA EcoPrime SMB patented technology licensed from Advantage of SMB technique: Continuous (24/7) operation Increased productivity (up to 10 fold) Reduced solvent consumption (90%) *formerly BTS= BAYER TECHNOLOGY SERVICES 5

6 Advanced fluid control. Simplified. The EcoPrime SMB is engineered without an internal recycling pump, providing a longer life time of high flow rate pump and columns And the patented concept eliminates the need of a third high pressure inlet pump. Reduces complexity, risk and cost. 6

7 Productivity under pressure LEWA ecoflow metering pumps, the gold-standard in precision at high pressures in demanding environments, are the heart of the EcoPrime SMB. Used in the vast majority of production scale chromatography system over the past 40 years, the LEWA ecoflow pump you can rest assured in the reliability needed by continuous production systems. 7

8 Optimized process design. Sophisticated control. Our history as fluid dynamics experts intersects with the Bayer patented innovation for intelligent separation approach that simplifies SMB. We marry advanced industrial control with a patented process. Electronic records and compliance are built into the manufacturing-ready system. 8

9 The most reliable fluid delivery Exclusive on EcoPrime SMB: LEWA ecoflow triplex pump Accurate delivery of target flow rate Low pulsation less stress on packed media Close-loop control with mass flow meters (MFM) Frequency and/or stroke adjustment Results: Extract pump in EcoPrime SMB 15 minutes = 15 switches no flow rate variation at switching LEWA Nikkiso Group; For more information contact: ecoprime@lewapt.com 9

10 Proprietary valve design enhances performance Valve is critical to SMB quality: In SMB multiple valves are switched at high frequency (min 0.5 min) 24/7 Avoid pressure spikes at switching Minimal dead volumes Short switching time (< 0,1 s) Long lifetime Maintenance-friendly (exchange of seals) Endurance test illustrates robust design Test Parameters Pressure: - Inlet 8MPa (CV1) - Outlet 6MPa (CV2) 500,000 times open-close at pressure Result: Zero fail High endurance, low hold-up fast acting: Design exclusively for EcoPrime SMB. 10

11 Performance testing results show fine separation Initial Conditions Final Conditions Sample Ratio (%) Conc. (g/l) Weight (mg/min) Flow (ml/min) Cycle Raff Ext Raff Ext Raff Ext 3:30:40 Eluent 16 ND ND 15.2 (+4mL) 3:30:40 Feed :48:03 Extract ND (+1mL) 4:05:26 Raffinate ND (+3mL) 7:37:48 Waste 16 ND ND Step: 90sec Exceptional test results (generic enantioseparation)

12 HMI operator friendly, robust manufacturing style Main screen with flow diagram Color-marking flow paths Feed: green Eluent: blue Raffinate: yellow Extract: magenta Method management Historic trends Alarm list Event list Login screens / Access control 12

13 Process Development - straightforward Simply define parameters/boundaries for your SMB process Resin and solvent composition Feed concentration, temperature Bed height Cycle time Number of columns, columns/zone Flow rates of the four pumps Feed Extract Raffinate Eluent Intelligent software on EcoPrime SMB makes process development straightforward 13

14 Historic trends automatically configured Monitoring of process trends during operation --- saved in historian LEWA Nikkiso Group; For more information contact: 14

15 Column testing is individualized and recorded Each individual column - information saved in data base 15

16 Example performance testing at end user Sample Ratio (%) Conc. (g/l) Flow (ml/min) Cycle Raff Ext Raff Ext Eluent 0 ND ND 9.7 Feed Extract Raffinate Step: Waste sec LEWA Nikkiso Group Surpasses customer requirements 16

17 How teamwork results in a world-class system optimized for your application This extraordinary technology is the collaboration of the expert teams in Nikkiso and Nikkiso s daughter company LEWA. Building on the Bayer licensed SMB approach the LEWA-Nikkiso global organization has melded their expertise in separations science, automation and hardware to produce the EcoPrime SMB. This team takes your information and produces a system individualized to your application based on the EcoPrime SMB technology framework worked out over years of design and pilot work. The Nikkiso team leads the design discussion and delivers the automation / control portion of the EcoPrime SMB. The LEWA team delivers the pump and fabricates the fluid flow portion of the hardware and lending FAT facilities to the Nikkiso engineers who follow the system to the field supporting installation. A single source leveraging unique original technology expertise globally. The result? Customers that are impressed and with new cost effective ways to expand their drug therapy market. German, Japanese and American know-how are represented by the LEWA-Nikkiso EcoPrime SMB team pictured here 17

18 Custom size to your need Our patented design can be applied to pilot to production capacity. Get in contact with us to size to your separation. Minimized dead volumes to reduce band broadening effects & avoid asymmetric design between columns 18

19 EcoPrime SMB Established robust technology customer proven patented technology Substantial cost / time savings up to 10 fold productivity increases up to 90 % buffer consumption reducing CSP amount Seamless, fast scale up bench top batch to production scale accelerated implementation Minimizing risk due to continuous operation scale reduction Our LEWA-Nikkiso SMB specialists 19

20 Industrial-scale chromatography systems by LEWA Batch chromatographic systems LEWA EcoPrime LPLC using LEWA digital drive technology Multi-column continuous chromatographic systems LEWA EcoPrime SMB licensed from LEWA EcoPrime Twin based on ChromaCon s CaptureSMB license 20

21 For more information: America s Europe Asia LEWA-Nikkiso America, Inc. 132 Hopping Brook Road MA Holliston Tel: Fax: sales@lewa-inc.com Headquarters LEWA GmbH Ulmer Str Leonberg GERMANY Tel: Fax: lewa@lewa.de NIKKISO CO. LTD. Yebisu Garden Place Tower 22nd Floor 20-3, Ebisu 4-Chome, Shibuya-ku Tokyo Tel: Fax: LEWA, Creating Fluid Solutions, the LEWA logo, LEWA Intellidrive and LEWA EcoPrime are trademarks of LEWA GmbH. Bayer and Bayer stylized logo are trademarks of Bayer AG Nikkiso and Nikkiso stylized logo are trademarks of Nikkiso. ChromaCon, Contichrom and CaptureSMB are registered marks of ChromaCon AG. All goods and services are sold subject to the terms and conditions of sale of the company within LEWA which supplies them. A copy of these terms and conditions is available on request. Contact your local LEWA representative for the most current information LEWA Nikkiso America, Inc. All rights reserved. LEWA Bioprocess Technologies, Inc. 8 Charlestown Road Devens, MA USA Tel: sales@lewapt.com