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Tx Single Use Seminar Jun09

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  • 1. TangenX - Sius TM Single Use Tangential Flow Filtration Cassettes Mark Perreault, TangenX Technology
  • 2. TangenX TFF Membranes and Cassettes
  • 3. TangenX Technology Corp.– Shrewsbury, MA
    • TangenX founded in January 2004 - Shrewsbury, MA
    • Novasep acquires a controlling interest in TangenX effective September 1, 2006
    • TangenX and Novasep introduce validated TFF reusable products at IBC in Boston, October 2007
    • TangenX and Novasep introduce industry’s first validated TFF reusable products at IBC in California, Dec. 2008
    • + 40 years Membrane and TFF Experience
  • 4.  
  • 5.  
  • 6.  
  • 7.  
  • 8. TangenX Overview Ultrafiltration Membranes
  • 9. TangenX Membranes - mPES
  • 10. TangenX Membranes - mPES
  • 11. TangenX Membranes - mPES
  • 12.
    • “ Single Cast”, uniquely controllable process
      • Reduced number of manufacturing steps
        • Lower cost and excellent consistency and reliability
      • Tightly controlled microporous/UF transition interface.
        • Balanced flux and selectivity
        • No breakthrough of the UF skin
        • Macroporous substructure for maximized flux
    SEM X-Section of the ProStream 100KD
        • Integral “cast-modification” of the membrane surface chemistry
          • Addition of a second (hydrophilic) polymer into the pre-casting membrane solution
          • Consistent surface modification that deliver
        • Lower protein binding
        • Excellent chemical resistance
    TangenX Membranes - mPES
  • 13. TangenX mPES Membranes Two (2) Membrane Chemistries
    • Modified Polyethersulfone (PES) membranes:
    • ProStream TM : 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD, 0.1µm, 0.2µm
      • Neutrally Balanced Charge
      • Low Protein Binding
    • HyStream TM : 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD, 0.1µm, 0.2µm
          • Hydrophilic - Minimal fouling with hydrophobic molecules
          • Low Protein Binding
    ProStream TM 10 kD (1000X) HyStream TM 10 kD (1000X)
  • 14.
    • TangenX offers two membrane chemistries; ProStream and HyStream
    • Available in multiple cutoff’s: 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD, 0.1µm, 0.2µm
    • ProStream
    • mPES membrane cast on a polypropylene non-woven
    • The membrane is neutrally charged, rendering it low binding for enhanced flux and recovery
    • The membrane has excellent chemical resistance and very low extractables.
    • HyStream
    • mPES membrane also cast on a polypropylene non-woven
    • It’s modification renders it extremely hydrophilic in nature, resisting fouling from hydrophobic species such as fat, lipids, and various antifoam agents.
    • The membrane has good chemical resistance and offers an alternative to RC membranes in some cases.
    ProStream 10KD HyStream 10KD TangenX Membranes - mPES (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) ProStream (+/-) (+/-) (+/-) (+/-) (+/-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) Un-Modified PES (+) (+) (+) (+) (+) (+)
  • 15. TangenX Membranes - mPES
  • 16. TangenX Membranes - mPES
  • 17.
    • TangenX membranes demonstrate exceptional selectivity when challenged with “model” proteins in solution
    • Membranes were challenged with model proteins and the protein rejection was quantified
    • The rejection of each protein for a given MWCO membrane was plotted against the protein’s molecular weight
    • The selectivity curves generated show discrete selectivity profiles with no overlap
    Membrane Selectivity Curves for: ProStream Membranes HyStream Membranes Contact Angle Measurement (water at 20 o C) HyStream SEM of the HyStream 0.1um surface at 20,000X Data generated in triplicate using 13cm2 stirred cells TangenX Membranes - mPES
  • 18. TangenX Membranes - mPES
    • Typical 3 to 6 rule for MWCO selection
  • 19.
    • Better selectivity allows users to use a higher MWCO membrane for improved flux.
    • TangenX membranes can completely retain molecules as little as 2X different in MW.
    • Example:
      • TangenX 100KD ProStream modified PES
      • Purified MAb concentration, 10mg/ml - (~150KD)
      • Typical flux is 90 to 100 LMH
      • Greater than 99% retention
    TangenX Membranes - mPES
  • 20. 100KD ProStream mPES MAb Optimization – 10mg/ml
  • 21. TangenX Membranes - mPES
    • Typical 3 to 6 rule for MWCO selection
  • 22.
    • When fractionating, better selectivity allows users to separate molecules closer in molecular weight.
    • TangenX membranes can fractionate molecules as little as 2X different in MW.
    • Example:
      • TangenX 100KD ProStream modified PES
      • Purified BSA concentration, 1.0mg/ml - (67KD)
      • Typically less than10% retention means BSA is not retained by the 100KD membrane
    TangenX Membranes - mPES
  • 23.
    • TangenX membranes offer greater flux & selectivity than traditional mPES
    TangenX Membranes - mPES
  • 24. TangenX - Sius TM Single Use Tangential Flow Filtration Cassettes
  • 25. ISPE Carolina South-Atlantic Chapter Sius TM Single-Use TFF Cassettes
    • Single-use technology has made bioprocesses:
      • Cleaner
      • Safer
      • More Efficient
    • Single-use technology has enabled a typical purification process to eliminate numerous costly clean in place (CIP) operations
  • 26. ISPE Carolina South-Atlantic Chapter Sius TM Single-Use TFF Cassettes
  • 27. Sius TM Single-Use TFF Cassettes
  • 28. Sius TM Single-Use TFF Cassettes
  • 29.
      • The first truly disposable TFF cassette design
      • The Sius TM cassette incorporates a unique patented* design with a more automated process for assembly.
      • Cassettes are direct retrofits for all existing TFF devices
    *patent pending Sius TM Single-Use TFF Cassettes
  • 30.
    • Full range of formats and MWCO (molecular weight cut offs)
    • Pre-sanitized with 0.2M Sodium Hydroxide
    • Certified low TOC and endotoxin
    • Equilibrate & ready-to-use
    • Economic TFF Solution
    Benifits – Sius TM Cassettes
  • 31.
      • Sius TM -LS – from laboratory to small pilot scale
      • Available in 0.1m 2 , 0.2m 2 , and 1.0m 2
      • Stack cassettes up to 0.5m 2
      • Sius TM – from pilot to process scale
      • Available in 0.5m 2 , 1.5m 2 , and 2.5m 2
      • Stack cassettes up to 7.5m 2
    Linear Scalability – Sius TM Cassettes
  • 32. “ L” Screen 1.0mm Open Channel Flow Spacers Low Viscosity High Viscosity & Particulates 0.5mm Open Channel Membrane Flow Spacers Lower Cross Flow Rate Higher Cross Flow Rate Higher Cross Flow Velocity Lower Cross Flow Velocity Channel Options – Sius TM Cassettes
  • 33.
    • Sius™ cassettes have been designed and constructed using FDA approved materials that have been validated for use for demanding biopharmaceutical applications.
    • The Sius™-LS laboratory scale and Sius™ process scale TFF cassettes are purpose-built for single use processing with optimal performance that is equivalent to our NovaSet reusable product line.
    • Each c assette is manufactured in a fully validated and documented manufacturing process according to the principles of cGMP and meet specified release criteria.
    • Cassettes are manufactured using approved standard operating procedures and individually tested for both air integrity and hydrodynamic performance.
    Manufacturing – Sius TM Cassettes
  • 34.
    • Sius TM Single Use TFF Cassettes utilize an innovative 2 stage assembly process
    • Membranes and permeate channels are bonded together
    Manufacturing – Sius TM Cassettes
    • Retentate channels consist of rigid plastic frames and turbulence promoting screens
    • The assembly is instantly bonded together using medical grade silicone pressure sensitive adhesive
    • Benefits
        • Process mfg. efficiency greatly improved
        • Reduced costs
        • Reduces lot rejection
    Patent Pending
  • 35.
    • Materials of Construction
      • Membrane PES
      • Membrane Support Polypropylene
      • Screen Polypropylene
      • Channel Spacer HDPE
      • Filtrate Seals Urethane
      • Gasket EPDM
    • Specifications
      • Maximum Pressure
        • 7 bar (100 psi) forward; 0.33 bar (3 psi) reverse
      • Air Integrity
        • UF cassette ≤ 30 sccm @ 1 bar (15 psi)
        • MF cassette ≤ 30 sccm @ 0.2 bar (3 psi)
      • Recirculation Flow
        • 'L' Screen 6-9 lpm/m2 @ 0.7 bar (10 psi)
        • 'J' Channel 1-1.5 lpm /m2 @ 0.3 bar (1.5 psi)
    • Manufacturing
      • Fully validated process, developed and documented in accordance with cGMP principles
      • Quality Control lot release testing includes 100% device integrity and hydrodynamic testing
      • Sanitized and packaged in 0.2M NaOH
      • Manufacturing process is fully validated, a validation guide is available to reference
    Specifications – Sius TM Cassettes
  • 36. Product Support – Validation Guide
  • 37. Product Support – C of C
  • 38. Product Support – Product Use
  • 39. Product Support – Product Use
  • 40.
    • Sius™ cassettes have been designed and constructed using FDA approved materials that have been validated for use for demanding biopharmaceutical applications.
    • The Sius™-LS laboratory scale and Sius™ process scale TFF cassettes are purpose-built for single use processing with optimal performance that is equivalent to our NovaSet reusable product line.
    • Each c assette is manufactured in a fully validated and documented manufacturing process according to the principles of cGMP and meet specified release criteria.
    • Internally audited by Novasep QA
    • Cassettes are manufactured using approved standard operating procedures and individually tested for both air integrity and hydrodynamic performance.
    Product Support – Manufacturing
  • 41. Single Use - Summary
    • Single-Use TFF eliminates the need to flush with costly purified water or measure water permeability rates, saving time and resources.
    • Pre-Sanitized cassettes are installed, equilibrated with buffer, and used in processing.
    • Development work, scale up and processing can be conducted nearly 50% faster without the need for membrane cleaning and measurement or water flux recovery.
    • Cassette performance is more consistent from run to run as each process occurs using a new membrane.
    • Cross-contamination is minimized with single-use cassettes.
  • 42. TangenX - NovaSet TM Tangential Flow Filtration Cassettes
  • 43. NovaSet TM -LS Reusable TFF Cassette
  • 44. NovaSet TM Reusable TFF Cassette
  • 45. NovaSet TM Reusable TFF Cassette
  • 46. NovaSet TM Reusable TFF Cassette
  • 47. NovaSet TM - Feed Channel Options Low Viscosity High Viscosity & Particulates Higher Cross Flow Velocity Lower Cross Flow Velocity Lower Cross Flow Rate Higher Cross Flow Rate “ H” Screen Membrane Suspended Screen Flow Spacers “ L” Screen
  • 48. NovaSet TM Reusable TFF Cassette
  • 49. NovaSet TM Reusable TFF Cassette
  • 50. NovaSet TM Reusable TFF Cassette NovaSet™ Cassette 0.5, 1.5 or 2.5m 2
    • Specifications
      • Maximum Pressure
        • 7 bar (100 psi) forward; 0.33 bar (3 psi) reverse
      • Recirculation Flow
        • 'H' Screen 6-9 lpm @ 1 bar (15 psi)
        • 'L' Screen 6-9 lpm @ 0.7 bar (10 psi)
        • 'S' Channel 1-1.5 lpm @ 0.3 bar (1.5 psi)
    • Manufacturing
      • Fully validated process, developed and documented in accordance with cGMP principles
      • Quality Control lot release testing includes 100% device integrity and hydrodynamic testing
      • Individually packaged in a sealed foil lined bag and outer cardboard carton
      • Wet packed in 20% Glycerin and 0.1% Sodium Azide
    • Materials of Construction
      • Membrane: PES
      • Membrane Support: Polypropylene
      • Screen: Polypropylene
      • Encapsulant: Urethane
      • Gasket: Platinum Cured Silicone
  • 51.
    • Sius and NovaSet cassettes provide an interchangeable TFF platform
    • Same membrane used in both products
    • Comparable cassette performance
    • TangenX cassettes allow scale up and scale down between both cassette formats
    NovaSet TM vs. Sius TM TFF Cassette Performance
  • 52.
    • Pressure drop vs. crossflow rate confirms scalability within the same product family
    • Also confirms interchangeability between family of cassettes
    • TangenX cassettes allow scale up and scale down between both cassette formats
    NovaSet TM vs. Sius TM TFF Cassette Performance
  • 53. NovaSet TM vs. Sius TM TFF Cassette Performance
      • 5 mg/ml BSA
      • TMP 25psi
      • CFF = 0.6L/min/ft 2
    • Flux and recovery comparable
    • TangenX cassettes allow scale up and scale down between both cassette formats
    • Application: 5X BSA concentration
  • 54. TangenX - TFF Cassette Holders for NovaSet TM and Sius TM
  • 55. BioPharm TFF – Laboratory
  • 56. BioPharm TFF – Pilot
  • 57. BioPharm TFF – Process
    • NovaSet-75 Hydraulic TFF Cassette Holder
    • NovaSet-300 Hydraulic TFF Cassette Holder
  • 58. TangenX - Sius TM Filter Plate Insert (FPI)
  • 59.
      • The FPI follows the disposable TFF cassette design
      • FPI direct retrofits for all existing TFF devices
      • The filter plate insert system provides a disposable flow path for Sius cassettes
    Disposable Flow Path for Sius TM Cassettes
  • 60. Filter Plate Insert (FPI)
  • 61. System Design
    • Insert plates may be used with existing filter holders by replacing cassettes
    • All threaded connections in the fluid path are isolated by an o-ring – "sanitary design“
    • Low cost dedicated holder available
    System Design
  • 62.
    • Type 304L/316 Stainless Steel
      • Clamp Base, Cover
      • Washers / Spacers
      • Screws
    • Brass Nuts
      • 1-¼" Socket Hex Nut
    • Polyethyelene (Contact Surface)
      • Filter Plate Insert
      • Barbed Fittings
    • Polypropyelene (Contact Surface)
      • Luer Lock Fittings
    • EPDM (Contact Surface)
      • O-Rings
    Materials of Construction
  • 63. Insert Plate Features
    • Each plate has (1) set of Feed/Retentate Ports and (1) set of Filtrate Ports
    • Each plate has (2) male luer lock pressure tap connections (supplied with caps)
    • Plates are approximately 1" thick with each port entrance clearly identified
    • Each plate is sanitized, dried and individually bagged
      • Includes CofC/A for traceability
    • Compatible with NovaSet reusable cassettes.
    Insert Plate Features
  • 64.
    • Similar design and function to process plates
    • To be used in NovaSet-LS hardware
    FPI - Laboratory Scale
  • 65. Options
    • Mini T/C or 1" T/C Fitting replaces Barb (not shown)
    • Analog Gauge Option
    FPI - Options
  • 66.
      • The filter plate inserts (FPI) are available for Beta testing – June 09
      • The functionality of the FPI with competitor's holders is underway
      • Various hose barb and instrument connection ports are available, no standard has been established yet
      • Filter plate inserts will be provided with:
        • MSDS (material safety data sheet)
        • COA (certificate of analysis)
        • COO (certificate of origin) BSE statement
        • shelf life
        • Extractables & leachables
    Current Status of FPI
  • 67. TangenX Overview Thank You For Your Attention

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