Novel High Flux Single-use Filtration for Fed Batch Clarification
TFDF® (Tangential Flow Depth Filtration) technology unites the benefits of tangential flow (TF) and depth filtration (DF) in a closed and single-use solution that enables 1000 LMH.
High Flux Single-use filter clarification
When used for cell culture clarification, TFDF® Technology delivers unprecedented high flux, high capacity, low turbidity, and minimal dilution. The result is a single-use, Gamma-irradiated and closed solution with linear scaling from 1 L to 2000 L. Clarification with the TFDF® Technology provides an alternative to centrifugation and primary depth filters. TFDF® output turbidity and impurity profile are highly comparable to those of centrifugation.
TF + DF = TFDF® combined benefits
Tangential Flow
High cell density
Poor product passage
Depth Filtration
Low cell density
Excellent product passage
Tangential Flow Depth Filtration
High cell density
Excellent product passage
TUBULAR DEPTH FILTER OPERATED IN TANGENTIAL FLOW MODE
Tangential flow through the lumen
- Low concentration polarization minimizes fouling and turbidity breakthrough
- Robustness for challenging feed stocks
Thick wall depth filter
- High filtration capacity
- Short, highly inter-connected paths do not retain product
Synergistic Benefits
- High flux > 1000 LMH
- Low hold-up volume
- Small footprint
- Simple setup and disposal
- Scalable from 1-2000L
- Process in 3-6 hours
FILTER, FLOW PATH AND SYSTEM AS ONE SOLUTION
NOVEL technology
High flux single-use filtration for Fed-Batch clarification
Combines tangential flow with depth filtration
High performance
High flux, high capacity, low turbidity, minimal dilution
Integrated, Automated
Integrated hardware, software, flow path
Automated process control logic
Scalable
Systems scale from lab to process
Flow paths capacity increases with tube number and length
Global support
Work with Repligen Field Applications Specialists from consultation to implementation
HOW IT WORKS
PERFORMANCE IN therapeutic protein CLARIFICATION
1L CHO Harvest, 650 LMH, 3 cm2 Filter
Cell Culture Feed
Volume 1.0 L
%PCV 6.6 %
VCC 2.5 x 107
Viability 80%
Titer 3.0 g/L
Turbidity 1196 NTU
Permeate Pool
Pool Volume 1.2 L
Process Time 6 hours
Yield > 90%
Turbidity 88 NTU
NTU reduction 92%
1L CHO Harvest, 1300 LMh, 3 cm2 Filter
Cell Culture Feed
Volume 1.0 L
%PCV 6.6 %
VCC 2.5 x 107
Viability 80%
Turbidity 1182 NTU
Permeate Pool
Pool Volume 1.2 L
Process Time 3 hours
Yield > 90%
Turbidity 94 NTU
NTU reduction 91%
1L CHO Harvest, 1950 LMH, 3 cm2 Filter
Cell Culture Feed
Volume 1.0 L
%PCV 6.6 %
VCC 2.5 x 107
Viability 80%
Titer 3.0 g/L
Turbidity 1182 NTU
Permeate Pool
Pool Volume 1.2 L
Process Time 1.5 hours
Yield > 90%
Titer 3.0 g/L
Turbidity 101 NTU
NTU reduction 91%
Cell Culture Feed
Volume 500L
%PCV 7%
VCC 1.5 x 107
Viability 80%
Titer 3.0 g/L
Comparable or lower HCP and DNA levels to centrifugation and depth filtration
No filter fouling with high LMH
Volume 1L
%PCV 6.8%
VCC 2.3 x 107
Viability 92%
Titer 5.9 g/L
CC Feed Turbidity 954 NTU
Permeate Pool Turbidity 92 NTU
Flux 1300 LMH
REPLIGEN-GUIDED IMPLEMENTATION ENSURES SUCCESS
The Repligen Field Application team with expertise in TFDF® technology will provide support from consultation to implementation globally.
Consultation |
Evaluation |
Development |
Implementation |
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Resources
Lentiviral vector manufacturing process enchancement utilizing TFDF® technology
by Thomas Williams, Oliver Goodyear, Lee Davies, Carol Knevelman, Michael Bransby, Kyriacos Mitrophanous and James Miskin
Cell and Gene Therapy Insights, April 2020