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Demonstration of XCell ATF 2 and XCell ATF 6 Single-use Performance Repligen Corporation | 41 Seyon Street, Building 1, Suite 100 | Waltham, MA 02453 | www.repligen.com © 2016 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or its affiliate(s) or their respective owners. Introduction Product Characterization Tests 0 20 40 60 80 100 0 20 40 60 80 100 0 4 8 12 16 20 Viability (%) VCD (E 6 Cells/mL) Time (days) XCell ATF 6 SU XCell ATF 6 SS 0 20 40 60 80 100 0 40 80 120 0 4 8 12 16 20 Viability (%) VCD (E 6 Cells/mL) Time (days) XCell ATF 2 SU XCell ATF 2 SS SUMMARY XCell™ ATF 6 Single-use and XCell™ ATF 2 Single-use both exhibited similar cell growth, viability and cell specific productivity profiles compared to respective stainless steel versions. Data not shown for cell specific productivity. Both XCell™ ATF 6 single-use and stainless steel devices demonstrated compatibility with SUBs (Single Use Bioreactors) Perfusion Cell Culture Performance Characterization Tests on XCell™ ATF SU Units Test Results XCell™ ATF 2 Single-use XCell™ ATF 6 Single-use Visual Inspection Appearance Pass Pass Diaphragm Integrity Test (DIT) 25psi Pass Pass Assembly Integrity Test (AIT) 25psi Pass Pass Max Pressure Limit Test (MPLT) 50psi Pass Pass Filter Integrity Diffusion Test Pass Pass Water Flux @ 2, 4, 6 TMP Pass Pass Assembly Cycle Test 100,000 or 2M* cycles Pass Pass Sterility Media Hold Pass Pass Perfusion Culture CHO cells Pass Pass 25 psi-25 min 25 psi-25 min AIT 25 psi-25 min DIT 50 psi-60 min 50 psi-60 min MPLT All post gamma irradiated single-use devices passed all product characterization tests Visual Inspection, AIT and DIT will be tested on each unit as release criteria prior to gamma irradiation of XCell™ ATF 6 single-use devices Extractable Study (Completed) Performed as per BPOG requirements ISTA 2a Shipping Study (Completed) Sterility Assurance Level Study (In progress) VDmax methodology per ISO 11137/AAMI TIR33 Shelf Life Stability Study (In progress) Real time study @ 22 o C for 27 months Accelerate temp. study @ 55 o C for 12 weeks (Predicts to 27 months at RT) VCD: 40E 6 cells/mL CSPR: 0.05nL/Cell/Day BR w.v: 40L (50L SUB) VCD: 80-100E 6 cells/mL CSPR: 0.02nL/Cell/Day BR w.v: 1.5L Shashi Kudugunti, Mario Sinani, W. Roy Lin * and James Rusche. Repligen Corporation, Waltham, MA 02453, USA Note: All product characterization tests were performed on post gamma XCell™ ATF Single-use devices. *Two XCell™ ATF 6 devices are evaluated up to 2M cycles(~100 days). Components XCell™ ATF Single-use device with 0.2um PES or 0.2um PS Filter Tubing set Reusable stand Materials Housing & Aseptic Connectors: Polycarbonate Hollow Fiber: PES/PS, Polyurethane, & Polypropylene Port Adhesive: Cyanoacrylate Diaphragm & Gaskets: Silicone Inlet Elbow: Polyvinylidene fluoride XCell™ ATF 2 (VCD & Viability) XCell™ ATF 6 (VCD & Viability) ACKNOWLEDGEMENTS XCell™ ATF Single-use Product Development Team, Repligen, Waltham-MA Ben Madsen & Nephi Jones (XCell™ ATF 6 beta testing), Thermo Fisher, Logan, UT Components XCell™ ATF Single-use device with 0.2um PES or 0.2um PS Filter Tubing set Reusable stand Materials Housing & Aseptic Connectors: Polycarbonate Hollow Fiber: PES/PS, Polyurethane, & Polypropylene Adhesive: PMMA Diaphragm & Gaskets: Silicone Tubing: Silicone & Pure Weld Benefits Identical cell culture and cell retention performance to the stainless steel devices No autoclaving required - up to 80% faster implementation time Configurable for sterile wetting and pre-use integrity testing More portable than stainless steel systems Reduced preparation, cleaning and validation activities XCell™ ATF 2 Single-use System XCell™ ATF 6 Single-use System Features 0.2um Polyethersulfone/Polysulfone Hollow Fiber Filters Fitted with convenient aseptic connectors Supplied gamma sterilized & double bagged Compatible with existing C24 and C410 XCell™ ATF Controllers Same pump and diaphragm configurations as existing XCell™ ATF stainless steel systems Lightweight and stable

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  • Demonstration of XCell ATF 2 and XCell ATF 6 Single-use Performance

    Repligen Corporation | 41 Seyon Street, Building 1, Suite 100 | Waltham, MA 02453 | www.repligen.com 2016 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or its affiliate(s) or their respective owners.

    Introduction

    Product Characterization Tests

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    0 4 8 12 16 20

    Viab

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    (%)

    VCD

    (E6 C

    ells/

    mL)

    Time (days)

    XCell ATF 6 SU

    XCell ATF 6 SS

    0

    20

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    40

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    0 4 8 12 16 20

    Viab

    ility

    (%)

    VCD

    (E6

    Cells

    /mL)

    Time (days)

    XCell ATF 2 SU

    XCell ATF 2 SS

    SUMMARY XCell ATF 6 Single-use and XCell ATF 2 Single-use both

    exhibited similar cell growth, viability and cell specific productivity profiles compared to respective stainless steel versions. Data not shown for cell specific productivity. Both XCell ATF 6 single-use and stainless steel devices

    demonstrated compatibility with SUBs (Single Use Bioreactors)

    Perfusion Cell Culture Performance

    Characterization Tests on XCell ATF SU Units

    Test Results

    XCell ATF 2 Single-use

    XCell ATF 6 Single-use

    Visual Inspection Appearance Pass Pass

    Diaphragm Integrity Test (DIT) 25psi Pass Pass

    Assembly Integrity Test (AIT) 25psi Pass Pass

    Max Pressure Limit Test (MPLT) 50psi Pass Pass

    Filter Integrity Diffusion Test Pass Pass

    Water Flux @ 2, 4, 6 TMP Pass Pass

    Assembly Cycle Test 100,000 or 2M* cycles Pass Pass

    Sterility Media Hold Pass Pass

    Perfusion Culture CHO cells Pass Pass

    25 psi-25 min

    25 psi-25 min

    AIT

    25 psi-25 min

    DIT

    50 psi-60 min

    50 psi-60 min

    MPLT

    All post gamma irradiated single-use devices passed all product characterization tests

    Visual Inspection, AIT and DIT will be tested on each unit as release criteria prior to gamma irradiation of XCell ATF 6 single-use devices

    Extractable Study (Completed) Performed as per BPOG requirements

    ISTA 2a Shipping Study (Completed) Sterility Assurance Level Study (In progress) VDmax methodology per ISO 11137/AAMI TIR33

    Shelf Life Stability Study (In progress) Real time study @ 22oC for 27 months Accelerate temp. study @ 55oC for 12 weeks (Predicts to 27

    months at RT)

    VCD: 40E6 cells/mL CSPR: 0.05nL/Cell/Day BR w.v: 40L (50L SUB)

    VCD: 80-100E6 cells/mL CSPR: 0.02nL/Cell/Day BR w.v: 1.5L

    Shashi Kudugunti, Mario Sinani, W. Roy Lin* and James Rusche. Repligen Corporation, Waltham, MA 02453, USA

    Note: All product characterization tests were performed on post gamma XCell ATF Single-use devices. *Two XCell ATF 6 devices are evaluated up to 2M cycles(~100 days).

    Components XCell ATF Single-use device with 0.2um

    PES or 0.2um PS Filter Tubing set Reusable stand Materials Housing & Aseptic Connectors:

    Polycarbonate Hollow Fiber: PES/PS, Polyurethane, &

    Polypropylene Port Adhesive: Cyanoacrylate Diaphragm & Gaskets: Silicone Inlet Elbow: Polyvinylidene fluoride

    XCell ATF 2 (VCD & Viability)

    XCell ATF 6 (VCD & Viability)

    ACKNOWLEDGEMENTS XCell ATF Single-use Product Development Team, Repligen, Waltham-MA Ben Madsen & Nephi Jones (XCell ATF 6 beta testing),

    Thermo Fisher, Logan, UT

    Components XCell ATF Single-use device with 0.2um

    PES or 0.2um PS Filter Tubing set Reusable stand Materials Housing & Aseptic Connectors:

    Polycarbonate Hollow Fiber: PES/PS, Polyurethane, &

    Polypropylene Adhesive: PMMA Diaphragm & Gaskets: Silicone Tubing: Silicone & Pure Weld

    Benefits Identical cell culture and cell retention performance to the

    stainless steel devices No autoclaving required - up to 80% faster implementation time Configurable for sterile wetting and pre-use integrity testing More portable than stainless steel systems Reduced preparation, cleaning and validation activities

    XCell ATF 2 Single-use System XCell ATF 6 Single-use System

    Features 0.2um Polyethersulfone/Polysulfone Hollow Fiber Filters Fitted with convenient aseptic connectors Supplied gamma sterilized & double bagged Compatible with existing C24 and C410 XCell ATF Controllers Same pump and diaphragm configurations as existing XCell ATF

    stainless steel systems Lightweight and stable

    Slide Number 1