1 / 51

Strategies for Single Use Tangential Flow Filtration In Biopharmaceutical Applications

Strategies for Single Use Tangential Flow Filtration In Biopharmaceutical Applications. Michael LaBreck Global Product Manager TangenX TFF Products. Sius TM Single Use TFF Cassettes. Sius TM and Sius TM -LS Overview. Sius TM family of single-use cassettes Purpose built for single-use

jefferyy
Download Presentation

Strategies for Single Use Tangential Flow Filtration In Biopharmaceutical Applications

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related