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Lab, Pilot and Process Chromatography Systems

Lab, Pilot and Process Chromatography Systems. Downstream Products. Mission To provide breakthrough products that enable faster production and lower cost development and manufacture of life saving biological drugs. Values

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Lab, Pilot and Process Chromatography Systems

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  1. Lab, Pilot and Process Chromatography Systems Confidential Sepragen Property

  2. Downstream Products Mission To provide breakthrough products that enable faster production and lower cost development and manufacture of life saving biological drugs. Values We bring our unbridled innovative spirit in service of you, the customer. We will reach for products and solutions that will help you develop and manufacture life saving drugs rapidly and cost effectively within the framework of compliance. We operate with a spirit of fairness, integrity, teamwork and mutual respect. We deliver what we promise.

  3. Sepragen CorporationInnovators in Bioprocessing • Sepragen has provided state of the art bio-processing technology to the biotech companies for over 25 years. Holds 16 patents. • Sepragen focused on processing of bio-processing: • Inventors of Radial Flow Chromatography • Quantasep Chromatography Systems and Skids • Quantasep 3000 SU Single use Chromatography Systems • Sepraflo Single Use Ion Exchange Resins • QS Buffer Dilution System • The purification products are already used in the biotech industry at Amgen, Baxter, GSK in FDA approved drug manufacture. • Twenty + FDA approved drugs and over 200 global installations. • Current Products address a served market in excess of $10Bn confidential

  4. Our Customers The “Who’s Who” of Pharma and Biotech confidential

  5. Downstream Products confidential

  6. New Downstream Products in Launch Confidential Sepragen Property

  7. Why choose Sepragen’sQuantasep Systems?Flexibility, Ease and Innovative Compact cGMP Design • Hardware • Fully Integrated system • Compact foot-print • Real time air ejection • Leak Detect • multimode detector • Pump stall feed-back • Software • Intuitive method builder • Easy P&ID Control • Comprehensive reports • Chromatograms & analysis Confidential Sepragen Property

  8. Precision Rotary piston pumps with stepper motor control • Positive displacement • Stepper motor control • No check valve for good clean-ability • Low pulsation • Small displacement/ rev= even flow

  9. Pump Features • Positive displacement (Ceramic piston and lining) • Stepper motor control • No check valve for good clean-ability • Low pulsation • Small displacement/ even flow

  10. Superior Gradient Performance- Quantasep 1000100:1 Turn down ratio on pumps

  11. Cleaning Validation Study • Process: • Inoculate • Incubate • Wash in NaOH • Water Wash • Swab at test 31 points

  12. Results of Microbial challenge study on Quantasep 1000

  13. Manual air valve Air Air Outlet Ultrasonic air sensor Flow Out Flow In 3 way valve Flow in Flow Out Benefits of Quantasep’s Auto Air Ejection system Auto Air Ejection Bubble Trap Causes Dilution of Product Unnecessary Gradient formation Doesn’t provide Protection of Column large air incursion Increases Hold Up volume • Protects against dilution of Product • No Unnecessary Gradient formation • Provides Protection of Column from any amount of air • Can be used to detect end of sample

  14. Elution Peak with Sepragen Active Air Ejection as compared to conventional Bubble Trap • Reduce Hold Up Volume • Minimize mixing of step change buffers • Improve Cleanability • Minimize sample loss in bubble trap

  15. Lab Quantasep Product Line: Quantasep 100 and 1000 Models:Integrated, compact, rugged and sanitary systems Quantasep 100 • Hardware Feature Set: • Two Pumps (Rotating Piston, positive displacement) • 12 inlets and 10 fractions • 3 columns • Forward flow, reverse flow and bypass • UV, pH, temp and Conductivity detection • Sensors for pressure, air, leak and rpm check • Stainless Steel Fluid-handling compartment • Biocompatible materials of construction • Outputs for remote data logging • Fraction collector interface trigger • Emergency pause Quantasep 1000

  16. Quantasep 1000LXLab, Pilot and Production Scale Systems: • QuantaSep 1000LX Dual Flow Capabilities: • Quantasep 1000LX has dual flow-paths: 0-100 ml/min and 0-1000 ml/min; Run in either mode by simply clicking on QSep100 or Qsep 1000 cGMP mode on Start-Up Screen • Quantasep 1000 LX ideal Scale Up system • Do PD work with 0-100 ml/ min flow-path • Use with up to capabilities to work with bioreactors from 3L to 20L • Quantasep 1000LX cGMP sanitary desgn • Run in cGMP mode with large flow-path with 21 CFR Pt 11 software Quantasep 1000 LX Quantasep 1000LX Quantasep 1000LX

  17. QuantaSep 1000 LX vs Akta Avant 150 and Akta Pilot

  18. QuantaSep 1000LX vs Akta Avant and Akta Pilot

  19. Advantages of QuantaSep Software vs Akta Avant 150 and Akta Pilot 600

  20. Lab, Pilot and Production Scale Quantasep Systems: Quantasep 1000LX, Quantasep 1800 and Quantasep 5000 Models • QuantaSep 1000LX Capabilities: • Quantasep 1000LX has dual flow-paths: 0-100 ml/min and 0-1000 ml/min; Run in either mode by simply clicking on QSep100 or Qsep 1000 cGMP mode on Start-Up Screen • Quantasep 1800 Capabilities • Run 100L/hr are in a compact, bench top cGMP sanitary system, perfect for 250L-500L bioreactor • Quantasep 5000 Capabilities • Run upto 300 L/hr with a mobile cGMP system sanitary system , Perfect for 500 to 2000L bioreactors Quantasep 1000 LX Quantasep 5000 Quantasep 1800

  21. Lab, Pilot and Production Scale Quantasep Systems: Quantasep 1000LX, Quantasep 1800 and Quantasep 5000 Models • QuantaSep 1000LX Capabilities: • Quantasep 1000LX has dual flow-paths: 0-100 ml/min and 0-1000 ml/min; Run in either mode by simply clicking on QSep100 or Qsep 1000 cGMP mode on Start-Up Screen • Quantasep 1800 Capabilities • Run 100L/hr are in a compact, bench top cGMP sanitary system, perfect for 250L-500L bioreactor • Quantasep 5000 Capabilities • Run upto 300 L/hr with a mobile cGMP system sanitary system , Perfect for 500 to 2000L bioreactors Quantasep 1000 LX Quantasep 5000 Quantasep 1800

  22. Lab, Pilot and Production Scale Quantasep Systems: Quantasep 1000LX, Quantasep 1800 and Quantasep 5000 Models • QuantaSep 1000LX Capabilities: • Quantasep 1000LX has dual flow-paths: 0-100 ml/min and 0-1000 ml/min; Run in either mode by simply clicking on QSep100 or Qsep 1000 cGMP mode on Start-Up Screen • Quantasep 1800 Capabilities • Run 100L/hr are in a compact, bench top cGMP sanitary system, perfect for 250L-500L bioreactor • Quantasep 5000 Capabilities • Run upto 300 L/hr with a mobile cGMP system sanitary system , Perfect for 500 to 2000L bioreactors Quantasep 1000 LX Quantasep 5000 Quantasep 1800

  23. Inside Look at Quantasep 10000 (10lpm) Chrom Systems • Compact, easy to service design • Muli-headed dual PD pumps • Sanitary construction • Pneumatic single block diaphragm valve manifolds • All necessary sensors

  24. Custom Skids 5 LPM and 30 LPM • Open Frame, easy to service design • Pneumatic control, constant pressure operation • Sanitary construction • Pneumatic single block diaphragm valve manifolds • All necessary sensors

  25. Purification of MAb using 250 ml RFC packed with Protein A media on Qsep100 system • Column size: 250 ml RFC • Resin: MAb Select • Flow rate: 100 ml/ min • Titer: 4 gms/l • Load: 1.75L (7 gms) • Recovery: 92% • Processing Time: 45 min

  26. Customizable Quantasep Open Skid Configuration • Customized Open Architecture: Mobile skid construction with user specified number of valves, pumps and pre and post column sensors for air, flowrate, pressure, conductivity, UV and pH • Operational up to 50 psi • Gradient and isocratic capability • Easy Access to Fluid components for serviceability • Optional plastic or 316L SS Flow-path • Optional Hazex standard of construction for flammables liquids • Complete TOP, FAT, SAT, IOQ and commissioning and Installation • Software PLC/SCADA/ C# uses encrypted database and is 21 CFR Pt 11 compliant • Can interface via OPC to Delta V, Foxboro, Siemens, Schneider, Allen Bradley confidential

  27. Project Management • URS Definition with Client • Preliminary Design • P&ID • Design • General Arrangement • Solid Modeling • Electrical Schematics • Software Screens • Design Review • Procurement • Fabrication • Sub-Assembly • SA Testing • Assembly • Assembly Testing • Functional Testing • Documentation (IOM, TOP) and Tagging • Crating and Ship • SAT • Install and Commissioning • On-going PM

  28. Case Study 10 ml/min cGMP systemFrom concept through design, fabrication and installation • Skid for Commercial Botox mfg • Created FRS by getting seemingly conflicting input from Engr, Mfg, Safety, PD and IT • Got convergence by recommending an open frame fluid-handling skid coupled by a nitrogen purged electrical enclosure operating inside a hood with gloves for access and fumigation and exhaust capability • Computer and HMI outside hood

  29. Custom Quantasep Process Chromatography Skids at GSK, Novartis, Neose • Gradient 2 Pump 10-40 Liter per minute per pump, 5-95% Gradient • 10 Inlets, 2 Outlets, Filter, Bubble Trap, Column fwd, Rev & Bypass • Pre and post column pH and Cond sensors, Multi wavelength UV • Sanitary 316L SS Piping, 304 SS Moblie Ex Proof Skid • Air sensor, Auto air removal and Bubble Trap with control system • Leak sensor, Pressure Sensor • Filter, Flow through and Bypass • CE, BASEEFA (class 1 Div1, T4) Certified ATEX explosion proof skid

  30. QS Chromatography System (1000LPH) with IBDChromatography using 10X concentrated Buffers • Full Chromatography Functionality including Manual and Auto operation, gradients, UV, sensors, valves, cGMP reports, chromatograms and analysis capability • Four Pumps for sample/ WFI, Concentrates, acid and base; 2 Flow meters, 3 pH sensors, 2 conductivity sensors and one UV sensors • Total Flow Accuracy +/- 1% actual flow or 0.3% FS • Composition Accuracy +/- 2% or 0.5% FS • pH Control +/- 0.1pH • Footprint 34” x 27”x 50” confidential

  31. QS Buffer Dilution System • Capabilities • Flow rates 5 lpm to 30 lpm • Footprint 30” x 27”x 42” • 110V and 90 psi instrument quality air • Total Flow Accuracy +/- 3% actual flow or 0.3% FS • Composition Accuracy +/- 5% or 0.5% FS • pH Control +/- 0.1pH Confidential Sepragen Property

  32. Performance: On-line Buffer Dilution Skids Concentrate 20%(5X) 10%(10X) 5%(20X) confidential

  33. QS Column Packing System LX • PC Driven Automated packing system • Reproducibility and consistency of packing • Different recipes for different columns and resins • Automated air removal, Slurry packing, bed stabilization and bed integrity testing • cGMP documentation of column qualification • Batch record reports and electronic storage confidential

  34. Single Use Flow-path Quantasep Systems

  35. Quantasep 3000 SU S.S Fluid Handling Module • Bench top System • Dual Pump System • Quick disconnect fittings • Easily wipe- downable • cGMP suitable

  36. Quantasep 3000 SU- Single Use • Ergonomic Design • Touch- screen built in computer & keyboard • Easily removable front and side panels • Removable flow- path

  37. Quantasep 300 SU 100/ 300 ml/min systemInside look at the flow-path (1.6 mm and 3.2 mm) UV sensor flowcell Peristaltic Pumps A & B pH sensor Inlet Valves Manifolds A & B Air sensor Flowmeter Pressure sensor Fraction Valve Manifold Pre-column Device (bubble-trap/ filter) Conductivity Sensor Lines to and from column Quick Disconnect Fittings

  38. Quantasep- Single Use Flowpath • First Single Use bench top system • No Cleaning Validation time • Down time between batches minimized • Remove tubing path and flow cell • Easy Change –over • Low cost of system and flowpath

  39. Critical Software Features of the Quantasep Software • WINDOWS 10 Based SOFTWARE PLATFORM • Intuitive method builder • Pt. and Click Manual and Auto Dashboard Control • Event and Alarm Log • Gradients and Buffer Dilution • Comprehensive run documentation and report • Trending and Data Analysis • 21 CFR Pt. 11 Compliance software • Security • Data Export Confidential Sepragen Property

  40. Manual Operating Screen • Simply Click on valves to select buffer, fraction and flow direction • Enter flowrate values near pump icon • Run Manual linear or step gradients from screen • Go through or bypass precolumn filter • For lab systems, inject sample manually or through sample loop • Monitor all sensors values

  41. Software FeaturesEasy operation, monitoring& control • Operation from graphical P&ID screen • Manual or Automated Modes • Unlimited Recipes with buffer and fraction changes based on time, volume, bed volumes, sensor values, air, pressure • Real-time Chromatogram with all sensor and flow variables with settable and auto-adjust ranges • Linear and step gradients • Constant Flow and Constant Pressure Operation • Real time event and alarm log for pressure, air and leaks • Manual Intervention in auto runs • Auto air eject • On-screen calibration of pumps and sensors • Chromatogram Analysis of HETP and Asymmetry

  42. Operating SCREENS For Auto Run AND Chromatogram

  43. Peak Identification and analysis

  44. Librarian for easy filing, retrieval and management of methods and run data

  45. Intuitive Method Builder • Tabular Excel type format - eliminates the hassle of programming • Step changes on time, volume, bed volume, air, UV, UV Slope, Air, % Peak Max, and Combined Variables • Automatic method validation

  46. Conductivity Sensor Calibration using the Quantasep Software

  47. Sensor Calibration from Quantasep Software

  48. Qsep Auto Gradient Run

  49. Real time overlays of Multiple Chromatograms

  50. Reports • Validation • track alarms, events, notes and any manual changes • Automatic analysis report • Calibration Report • Calibration data • Time between calibrations • Method and column information

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