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Enhanced Single-Use TFF Strategies for Biopharmaceutical Applications

Explore the efficient utilization of TangenX single-use TFF cassettes for streamlined biopharmaceutical processing. Learn about membrane properties, rejection characteristics, and time-saving benefits.

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Enhanced Single-Use TFF Strategies for Biopharmaceutical Applications

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  1. Strategies for Single Use Tangential Flow Filtration In Biopharmaceutical Applications Michael LaBreck Global Product Manager TangenX TFF Products Novasep Process: TangenX Tangential Flow Filtration Products

  2. SiusTM Single Use TFF Cassettes

  3. SiusTM and SiusTM-LS Overview • SiusTM family of single-use cassettes • Purpose built for single-use • Ready to Use - Reduced prep time • Delivered in 0.2M NaOH – Pre-sanitized • Cassette design for Development, Clinical, and Process Scale SiusTM 0.5 –2.5 m² surface area SiusTM-LS 0.01 –0.1 m² surface area

  4. HyStream Contact Angle Measurement (water at 20oC) TangenX Membrane Properties • Modified Polyether Sulfone (mPES) membranes currently available • ProStream: • 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD • Neutrally Balanced Charge / Low Protein Binding • HyStream: • 5kD, 10kD, 30kD, 50kD, 100kD, 300kD, 0.1µm, 0.2µm, 0.45µm, 0.65µm • Hydrophilic - Minimal fouling with hydrophobic molecules / Low Protein Binding Membrane Selectivity Curves for: ProStream Membranes HyStream Membranes

  5. Rejection Characteristics (UF Membranes) 100% Percent Rejection 0 1,000 10,000 100,000 Molecular Weight Novasep Process: TangenX Tangential Flow Filtration Products 5

  6. Rejection Characteristics (UF Membranes) 100% Percent Rejection 0 1,000 10,000 100,000 Molecular Weight Novasep Process: TangenX Tangential Flow Filtration Products 6

  7. Rejection Characteristics (UF Membranes) 100% Percent Rejection 0 1,000 10,000 100,000 Molecular Weight Novasep Process: TangenX Tangential Flow Filtration Products 7

  8. Pore Size Distribution (UF Membranes) pore size distribution 10KD Novasep Process: TangenX Tangential Flow Filtration Products 8

  9. Pore Size Distribution (UF Membranes) Competitor pore size distribution TangenX pore size distribution 10kD 10kD Novasep Process: TangenX Tangential Flow Filtration Products 9

  10. IBC Applications for Biopharmaceuticals La Jolla, CA June 1-3 2009 Novasep Process: TangenX Tangential Flow Filtration Products

  11. Single Use TFF Applications • Labor • Consumables • Workflow

  12. Single Use TFF Applications • Labor • Consumables • Workflow

  13. Set Up Sanitize Flush NWP Equilibrate Process Clean Flush Time NWP Storage Required Steps for TFF process RE-USABLE TFF

  14. Set Up Sanitize Flush NWP Equilibrate Process = 6 hrs Process Clean Flush Time NWP Storage Required Steps for TFF process RE-USABLE TFF

  15. Set Up Sanitize Flush Process = 6 hrs NWP Equilibrate Process Clean Time Flush NWP Total Time = 12 hrs Storage Required Steps for TFF process RE-USABLE TFF

  16. Required Steps for TFF process SINGLE USE TFF Process= 6 hrs Set Up Equilibrate Process Time

  17. Total Time = 7.0 hrs Required Steps for TFF process SINGLE USE TFF Process= 6 hrs Set Up Equilibrate Process

  18. Time Allocation Reusable TFF Process Time Savings versus Single Use Cassettes • A significant amount of time is spent preparing and cleaning reusable cassettes • Time is used more efficiently when using single-use cassettes • Water usage and utilities are conserved Time Allocation Single Use TFF Process

  19. Single Use TFF Applications • Labor • Consumables • Workflow

  20. Developing a Model for Single Use TFF • Consumables Include: • Purified Water • Buffers • Cleaning Solutions • Filtration Cassettes

  21. 250 230 Re-use Single Use 200 150 (L/sq. meter) 100 60 50 0 Buffer/WFI Usage Economy of Single Use TFF 75% Less Buffer / WFI Required

  22. Developing a Model for Single Use TFF • Consumables Include: • Purified Water • Buffers • Cleaning Solutions • Filtration Cassettes

  23. $4,500 $4,000 Supplier A Supplier B $3,500 Supplier C $3,000 Supplier D $2,500 $2,000 $1,500 $1,000 $500 $0 $ per sq meter surface area 1 Single Use – Economics Reusable Cassette Suppliers Average = $4,800 / meter2

  24. $4,500 $4,800 Re-use $4,000 Single use $3,500 $3,000 $2,500 $2,000 $1,500 $930 $1,000 $500 $0 $ per sq meter surface area 1 Single Use – Economics TangenX SiusTM Single Use TFF $930 per meter2 Other Supplier Reusable TFF $4,800 per meter2 80% Less per TFF cassette

  25. SiusTM and SiusTM-LS Overview • Membrane surface areas available • 100 cm², 200 cm², 0.1 m²: Process development • 0.5 m², 1.5 m², 2.5 m²: Pilot / Process SiusTM 0.5 –2.5 m² surface area SiusTM-LS 0.01 –0.1 m² surface area

  26. NovaSetTM Reusable TFF Cassettes Direct Scalability – From Single Use to Reusable Same channel geometry (ΔP and crossflow rate) Same membrane chemistry (Prostream and Hystream)

  27. Single Use TFF Applications • Labor • Consumables • Workflow

  28. Other Benefits to Single Use TFF • Reduces validation requirements • Process flexibility • Reduces risk of cross-contamination • Consistent membrane performance run to run • Removes process bottlenecks – Improves workflow

  29. SiusTM and SiusTM-LS Summary • Pre-sanitized, 100% Integrity Tested • Equilibrate and ready-to-use • Reduce Labor by 50% • Reduce Buffer / WFI by 75% • Full range of formats and pore sizes

  30. SiusTM Cassette Holders & Disposable Flow Path Inserts

  31. Disposable Flow Path Inserts • Filter Plate Inserts • Disposable Flowpath

  32. Disposable Flow Path Inserts Filter Plate Inserts (TFP75-SE16) 0.5 to 5.0 meter2 (up to 49 LPM) • Disposable • Pre-sanitized • USP Class VI Polypropylene • 1” TC (4) ports • Low cost SS Holder

  33. Disposable Flow Path Inserts TSPDI-VXBC: 10 m² up to 30 m² capacity TFP99-SP20 Filter Plate Insert (150 LPM)

  34. Disposable Flow Path Inserts Filter Plate Inserts – LS (TFPLS-SA08) 0.01 m2 to 0.1 m2 x 5 • Disposable • Pre-sanitized • USP Class VI Polypropylene • 3/4” mini TC or luer lock • Low cost SS Holder

  35. Single Use TFF: Case Study Novasep Process: TangenX Tangential Flow Filtration Products

  36. Michael Xenelis, EMD Serono Biotech Center IBC Bioprocess International Conference October 16, 2009 Novasep Process: TangenX Tangential Flow Filtration Products

  37. Novasep Process: TangenX Tangential Flow Filtration Products

  38. Total Process Time = 13.1 Hours Novasep Process: TangenX Tangential Flow Filtration Products

  39. Novasep Process: TangenX Tangential Flow Filtration Products

  40. Novasep Process: TangenX Tangential Flow Filtration Products

  41. Single Use TFF: Case Study Novasep Process: TangenX Tangential Flow Filtration Products

  42. Single Use TFF Case Study Single Use TFF vs. Reusable TFF • Recombinant Protein • 500L Batch Size • 10X Concentration / 5 volume Diafiltration • Process Flux = 100 LMH • Process Time = 4 Hours • Membrane Area = 2.5 Sq. Meter

  43. Single Use TFF Case Study Single Use TFF vs. Reusable TFF • Economic Model • 20 runs per year • Membrane costs • Labor and Overhead (validation) • WFI and Buffers

  44. Run # vs. Cassette Cost / Run $10,000 $9,000 Re-Usable Single Use $8,000 $7,000 $6,000 Cassette Cost per Run $5,000 $4,000 $3,000 $2,000 $1,000 $0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Run Number Single Use TFF Case Study Membrane Costs

  45. Single Use TFF Case Study • Labor and Overhead • Labor • QA / QC • Validation • Facilities – HVAC, Clean Room

  46. Labor and Overhead Rate $1,000/hr Reusable Single Use Reusable vs. Single-Use Process Cost hours $ hours $ $12,000 Store Set-Up 0.5 $500 0.5 $500 Sanitize 0.5 $500 $10,000 NWP Flush 0.5 $500 Flush NWP 0.5 $500 $8,000 Clean Equilibration 0.25 $250 0.3 $250 Process 4.0 $4,000 4.0 $4,000 Process $6,000 Clean 2.5 $2,500 1.0 $1,000 Cost (USD) Equili. Flush 0.5 $500 NWP $4,000 NWP 0.5 $500 Flush Store 0.5 $500 Sanitize $2,000 Set-Up $0 10.25 $10,250 5.75 $5,750 Process Type 1 2 Single Use TFF Case Study Labor and Overhead

  47. Single Use TFF Case Study Single Use TFF vs. Reusable TFF • Buffer Costs • WFI • Buffer chemicals • Consumables – filters, bags • Labor • QA/QC • Validation

  48. Buffer Cost $1.20 per liter Buffer Cost per Campaign Process Area 2.5 per m2 $16,000 Number of Runs 20 per campaign $13,800 Re-Usable $14,000 Cost per run Total Cost Single Use Re-Usable $690 $13,800 $12,000 Single Use $180 $3,600 $10,000 Buffer Cost (USD) Note: * Buffer cost includes $8,000 system, maintainance, buffers, raw materials, monitoring, and $6,000 disposal $3,600 $4,000 $2,000 $0 Single Use TFF Case Study Buffer Costs

  49. Re-Usable Single Use Cost / run Total Cost Cost / run Total Cost Overhead & Labor $10,250 $205,000 Overhead & Labor $5,750 $115,000 Buffer Usage $690 $13,800 Buffer Usage $180 $3,600 Consumables $500 $10,000 Consumables $2,000 $40,000 TOTAL COST $11,440 $228,800 $7,930 $158,600 Total Savings $70,200 Total Cost per Campaign $250,000 Re-Usable Single Use $200,000 $150,000 Total Cost $100,000 $50,000 $0 1 Single Use TFF Case Study: Summary

  50. 12 10.25 10 8 Reusable Hours 5.75 6 Single Use 4 2 0 Process Time Single Use TFF Case Study: Summary 45% Increase in Productivity

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