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TFDF™ Technology

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

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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 10
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 10
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 10
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


Theory


Demonstration


Optimization


Scale-up


Technology fit


Training


Flow path sizing


Validation


Experimental plan


Data analysis


System sizing


Long term training plan

 

About Repligen FAS

Resources

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