Single Pass TFF poster 2016
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This document discusses single-pass tangential flow filtration (SPTFF) as an alternative to batch ultrafiltration. SPTFF uses multiple membrane filter modules or sections in series to concentrate and diafilter solutions in a single pass, achieving higher conversion than batch systems. It compares SPTFF to batch ultrafiltration, outlines how SPTFF works, and presents testing results demonstrating its performance for intermediate concentration and final formulation of IVIG.
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Single Pass TFF poster 2016
- 1. Scaling Options • Existing holders and cassettes • Operation at lower flows Post-column (or other step) concentration • Reduce or eliminate intermediate pool tank Pre-column (or other step) concentration/ diafiltration • Desalt before IEX column or virus prefilter • Concentrate to increase capacity and reduce time Final formulation UF2 step (post batch UF/DF) • Avoid working volume limits • Maintain product quality, particularly if the product is heated to overcome viscosity effects What is SPTFF? Why use SPTFF? Where can SPTFF be used? Single-Pass Permeate Feed Tank Module RetentateRetentate Buffer Batch Permeate Feed PumpModuleFeed Pump Retentate RetentateDiafiltrate Filtrate Filtrate Feed Feed Feed Tank Retentate Filtrate Feed Single-Pass Permeate Feed Tank Module RetentateRetentate Buffer Batch Permeate Feed PumpModuleFeed Pump Retentate RetentateDiafiltrate Filtrate Filtrate Feed Feed Feed Tank Retentate Filtrate Feed Single-Pass Permeate Feed Tank Module RetentateRetentate Buffer Batch Permeate Feed PumpModuleFeed Pump Retentate RetentateDiafiltrate Filtrate Filtrate Feed Feed Feed Tank Retentate Filtrate Feed • Product is sufficiently concentrated/diafiltered after a single pass through filter assembly • No retentate return needed • Continuous operation • Product is not sufficiently concentrated/diafiltered after a single pass • Requires retentate return and multiple passes through filter • Batch operation • Simple operation -- Constant feed flow & retentate pressure -- Leverage existing holders • Simple system design -- Smaller pump -- Smaller footprint -- Low working volume allows higher final concentrations -- Simplifies product recovery • Once-through flowpath -- Run in-line with other unit operations -- Enables continuous processing -- Reduces pumping damage for sensitive products Scale down SPTFF testing SPTFF sizing with IVIG How does SPTFF work? • Batch processing: High feed flux and TFF devices operated in parallel results in low fluid residence time in membrane channels, hence low conversion -- 1 device in series -- feed flux ~ 6 LMM -- conversion ~ 15 - 20% • SP-TFF processing: Increase conversion by increasing fluid residence time in membrane channels via lower feed flux and longer channels -- 1 to 3 (or more) devices in series -- feed flux ~ 0.5 LMM or less -- conversion ~ 75 - 90+% Filtrate Retentate Retentate valve Filtrate Feed Feed Pump Separate permeate lines for each section Pf P1 P2 P3Feed Tank Section 1 0.1 m2 Section 2 0.1 m2 Section 3 0.1 m2 • Three Pellicon® 3 PLCTK 0.1m2 cassettes • Diverter plates • Recycled retentate/permeates • Feed flow excursions • Recovery flush • Cleaning & NWP recovery • Conversion -- Decreases with feed LMH -- Increases with # in series -- Decreases with feed g/L • Sizing -- feed flux based on conversion target -- membrane area based on batch volume and process time How does SPTFF compare with current batch UF? • Both use same cassettes and holders (need diverter plates) • Simplicity comes at a price: e.g. 1.2 - 3X membrane area versus batch sizing Application SPTFF Batch UF Intermediate UF, 19 g/L to 40 g/L 0.82 LMM* 2.7 LMM Final Formulation UF1, 18 g/L to 73 g/L 0.36 LMM 1.5 LMM Final Formulation UF2, 77 g/L to 174 g/L 0.18 LMM 0.53 LMM *LMM = feed flow rate in liters per minute per total square meters of membrane area. This is worth it for: • Plants where product pool volumes have increased beyond available tank capacities • Limited plant footprint (no room for batch operation) • Batch holdup limits final concentration (can’t get to target product g/L) Is there an advantage to using custom SPTFF modules or systems? SPTFF cleaning after IVIG • Repeatable NWP recovery for all 3 cassettes in series after use with IVIG Single-Pass Retentate 1SECTIONS SECTIONS2 1 2 3 Retentate Filtrate Filtrate Feed Feed Merck is a trademark of Merck KGaA, Darmstadt, Germany. Pellicon is a registered trademark of Merck KGaA, Darmstadt, Germany. All other marks are the property of their respective owner. © 2016 Merck KGaA, Darmstadt, Germany. All rights reserved. (Application Note Single-Pass Tangential Flow filtration: how to optimize, Merck) Single level • Horizontal sectioning • Separator plates Multiple level • Vertical sectioning Acknowledgments Eva Gefroh, Gislea Ramsey, Elizabeth Goodrich, Willem Kools, Randy Kirlin, Todd Ireland, Dan Dussault 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 2 4 6 8 10 12 14 0% 20% 40% 60% 80% 100% 120% 18-20 g/L 1-sections 18-20 g/L 2-sections 18-20 g/L 3-sections 75 g/L 1-sections 75 g/L 2-sections 75 g/L 3-sections Conversion Feed lpm/m2 total NWP(lmh/psi@25°C) NWP/WWPpre NWP section 1 NWP section 2 NWP section 3 NWP/NWPpre average Pre Post-lgG Clean 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 2 4 6 8 10 12 14 0% 20% 40% 60% 80% 100% 120% 18-20 g/L 1-sections 18-20 g/L 2-sections 18-20 g/L 3-sections 75 g/L 1-sections 75 g/L 2-sections 75 g/L 3-sections Conversion Feed lpm/m2 total NWP(lmh/psi@25°C) NWP/WWPpre NWP section 1 NWP section 2 NWP section 3 NWP/NWPpre average Pre Post-lgG Clean 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 3 sections, unequal area per section 3 sections, equal area per section Conversion Feed lpm/m2 total 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 2 4 6 8 10 12 14 0% 20% 40% 60% 80% 100% 120% 18-20 g/L 1-sections 18-20 g/L 2-sections 18-20 g/L 3-sections 75 g/L 1-sections 75 g/L 2-sections 75 g/L 3-sections Conversion Feed lpm/m2 total NWP(lmh/psi@25°C) NWP/WWPpre Pre Post-lgG Clean Batch Single Pass Tangential Flow Filtration (SPTFF) Jonathan Steen, Herb Lutz, Elizabeth Haacke, Kate Chefer, EMD Millipore Corporation Single-Pass Permeate Feed Tank Module RetentateRetentate Buffer Batch Permeate Feed PumpModuleFeed Pump Retentate RetentateDiafiltrate Filtrate Filtrate Feed Feed Feed Tank Retentate Retentate valve Filtrate Feed Feed Pump Separate permeate lines for each section Pf P1 P2 P3Feed Tank Section 1 0.1 m2 Section 2 0.1 m2 Section 3 0.1 m2 • Sizing is comparable between equal area sections & in sections in series • Equal area sectioning is well known and in the public domain