Repligen Corporation · NASDAQ:RGEN
Repligen — Technical Presentation (June 2017)
24 slides from Repligen's technical presentation, Jun 19, 2017
Slide 1: Performance and Economic Advantages of Single Use Flat Sheet Tangential Flow Filtration
Performance and Economic Advantages of Single Use Flat Sheet Tangential Flow Filtration Michael LaBreck Bioprocess Sales Specialist, TangenX Products, Repligen Web ads June 19, 2017, RTP, NC
Slide 2: TangenX TFF Cassettes
TangenX™ TFF Featuring the first purpose-built single-use cassettes • Reliable, consistent for tangential flow filtration Cassettes performance since 2007 • 80% reduction in filter cost • 50% reduction in labor use • 75% reduction in buffer use • Interchangeable, single-use, and Reliable, scalable,
Slide 3: TangenX TFF Cassettes
TangenX™ TFF Proven TFF cassettes in single-use and reusable formats Cassettes Reliable, consistent performance since 2007 Used in 200 Phase 1-3 processes and 5 commercial processes Scalable from bench to production Interchangeable single-use and reusable formats TangenX™ SIUS™ and SIUS™ P
Slide 4: TangenX Ultrafiltration Membranes
TangenX™ Ultrafiltration Membranes 4
Slide 5: Molecular weight cutoffs suit most operations
Molecular Modified Polyethersulfone (mPES) Membranes weight cutoffs suit most ProStream HyStream operations Molecular Weight Cutoffs (MWCO) Molecular Weight Cutoffs (MWCO) • 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, • 5kD, 10kD, 30kD, 50kD, 100kD, 100kD, 300kD 300kD, 0.1μm, 0.2μm, 0.45μm, 0.65μm TangenX™ Mem
Slide 6: Validated manufacturing process
Validated Modified Polyethersulfone (mPES) Membranes manufacturing process Polyethersulfone + Non-Polar Solvent TangenX™ Ultrafiltration Step 3 Membranes • The coated substrate Step 2 is immersed in a polar solvent (water) and • The casting solution is solidifies forming a Step 1 coated onto a non-
Slide 7: Efficient and robust membrane structure
Efficient and Balanced flux and selectivity robust are achieved using a controlled membrane manufacturing process that enables tight control of the structure membrane pore size. The manufacturing process ensures a controlled transition from the selective surface to the microporous support. TangenX™
Slide 8: Comparable rejection with superior selectivity
Comparable 100% rejection criteria with superior selectivity Percent Rejection TangenX™ Ultrafiltration Membranes 0 1,000 10,000 100,000 Molecular Weight 8
Slide 9: Highest flux at 30 mg/ml MAb
Highest flux at Modified Polyethersulfone (mPES) Membrane 30 mg/ml MAb Repligen Company P TangenX™ Ultrafiltration Membranes Compant G Company M Note: Flux is covered in formulation buffer 9 Source: IBC Applications for Biopharmaceuticals, La Jolla, CA, June 1-3 2009.
Slide 10: SIUS Single-use TFF Cassettes
TangenX™ SIUS™ Single-use TFF Cassettes 10
Slide 11: SIUS Single-use TFF Cassettes
TangenX™ SIUS™ Single-use TangenX™ SIUS™ PD TangenX™ SIUS™ TFF Cassettes First purpose-built single-use cassettes for tangential flow filtration Membrane Surface Areas Membrane Surface Areas 0.01 m² 0.02 m² 0.10 m² 0.5 m² 1.5 m² 2.5 m² Cassette Clamp Cassette Clamp Disposable Filter Plate Insert Dis
Slide 12: Up to 50% reduction in labor cost
Up to 50% Reduction in labor cost • Savings in labor cost Set-Up due to 50% reduction TangenX™ SIUS™ UF/DF Process time in prep time Sanitize 6 hours • 1 process run completed in 1 shift Flush NWP* Equilibration Process TangenX™ SIUS™ Single-use TFF Cassettes vs. Clean Reusable TFF Cassettes Reusabl
Slide 13: 75% reduction in buffer use
75% reduction in Buffer Usage (Liter / square meter of membrane area) buffer use 60 Repligen TangenX™ SIUS™ Cassette TangenX™ SIUS™ Reusable Cassette Single-use TFF Cassettes vs. Reusable TFF Cassettes 230 0 50 100 150 200 250 Other consumables: purified water, cleaning solutions 13
Slide 14: 80% reduction in filter cost
80% Reduction Cost / square meter in filter cost Repligen Repligen TangenX™ SIUS™ Cassette 1/5th the cost vs reusable Supplier A Supplier B TangenX™ SIUS™ Single-use TFF Cassettes vs. Reusable TFF Cassettes Supplier C Supplier D 14
Slide 15: Process volume and membrane area determine scale-up
Process volume and membrane area determine scale-up 15
Slide 16: SIUS Single-use TFF Cassettes
TangenX™ FEATURES SIUS™ Single-use TFF Cassettes • Pre-sanitized, ready to use • Compatible with holders from major suppliers (Millipore, Pall, Sartorius) • Uses high-performance TangenX™ mPES membranes • ProStream (low binding) • HyStream (hydrophilic) • Full range of formats and pore sizes First p
Slide 17: SIUS TFF Hardware
TangenX™ SIUS™ PD SIUS™ TFF SIUS™ PD Filter plate Hardware Horizontal clamp insert SIUS™ Filter plate insert SIUS™ Horizontal clamp Compatible with commercially available holders (Millipore, Pall, Sartorius) SIUS™ Vertical clamp 17
Slide 18: PRO Reusable TFF Cassettes
TangenX™ PRO Reusable TFF Cassettes 18
Slide 19: PRO Reusable TFF Cassettes
TangenX™ PRO Reusable TangenX™ PRO PD TangenX™ PRO TFF Cassettes Membrane Surface Areas Membrane Surface Areas 0.01 m² 0.02 m² 0.10 m² 0.5 m² 1.5 m² 2.5 m² Cassette Holder Cassette Holder 19
Slide 20: Interchangeable with SIUS Single-use Cassettes
Interchangeable with SIUS™ TangenX™ SIUS™ TangenX™ PRO Single-use Single-use TFF Cassettes Reusable TFF Cassettes Cassettes Seamless transition from bench-scale to production-scale Same channel geometry (∆P and crossflow rate) Same membrane chemistry (ProStream and HyStream) 20
Slide 21: Process volume and membrane area determine scale-up from SIUS to PRO
Process volume and membrane Membrane area: 2.5 m2 Membrane area: 40 m2 area determine This image cannot currently be displayed. This image cannot currently be displayed. scale-up from TangenX™ SIUS™ to PRO Reusable TangenX™ PRO SIUS™ Single-use SIUS™ Single-use PRO Reusable Single-use TFF provides
Slide 22: Comprehensive Regulatory Support Files for each cassette
Comprehensive This image cannot currently be displayed. Regulatory Product information • Cassette design Support Files for • Materials of construction each cassette Product performance • Membrane performance • Cassette performance • Cassette integrity • Cassette pre-flushing study This image cannot
Slide 23: Quality manufacturing
Quality manufacturing This image cannot currently be displayed. This image cannot currently be displayed. This image cannot currently be displayed. Manufactured in a fully validated and documented manufacturing process according to the principles of cGMP 23
Slide 24: Reliable, scalable, cost-effective solutions for tangential flow filtration
Reliable, This image cannot currently be displayed. scalable, cost-effective • Reliable, consistent performance solutions for since 2007 tangential flow • Used in >200 Phase 1 -3 processes, filtration 5 commercial processes • Scalable from bench to production • Interchangeable single-use and reusabl