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Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
Tx Single Use Seminar Jun09
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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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