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Novasep Process: TangenX Tangential Flow Filtration Products 1
Strategies for Single Use Tangential Flow FiltrationIn Biopharmaceutical Applications
Michael LaBreckGlobal Product ManagerTangenX TFF Products
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SiusTM Single Use TFF Cassettes
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SiusTM family of single-use cassettes Purpose built for single-usePurpose 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-LS 0.01 –0.1 m² surface area SiusTM 0.5 –2.5 m² surface area
SiusTM and SiusTM-LS Overview
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Contact Angle Measurement
(water at 20oC)
HyStream
Molecular Weight vs. % Rejection
0102030405060708090
100
0.1 1 10 100 1000 10000
Molecular Weight (kD)
% R
eje
cti
on
1K
3K
5K
10K
30K
50K
100K
300K
0.1um
Membrane Selectivity Curves for:
ProStream Membranes
HyStream Membranes
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
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Novasep Process: TangenX Tangential Flow Filtration Products 5
Rejection Characteristics (UF Membranes)
1,000 10,000 100,000
Molecular Weight
0
100%
Per
cent
Rej
ectio
n
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Novasep Process: TangenX Tangential Flow Filtration Products 6
Rejection Characteristics (UF Membranes)
1,000 10,000 100,000
Molecular Weight
0
100%
Per
cent
Rej
ectio
n
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Novasep Process: TangenX Tangential Flow Filtration Products 7
Rejection Characteristics (UF Membranes)
1,000 10,000 100,000
Molecular Weight
0
100%
Per
cent
Rej
ectio
n
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Novasep Process: TangenX Tangential Flow Filtration Products 8
Pore Size Distribution (UF Membranes)
10KD
pore size distribution
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Novasep Process: TangenX Tangential Flow Filtration Products 9
Pore Size Distribution (UF Membranes)
Competitor pore size distribution TangenX pore size distribution
10kD 10kD
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Novasep Process: TangenX Tangential Flow Filtration Products 10
Flux vs TMP Monoclonal Antibody 1
30 mg/ml Formulation Buffer CF=70ml/min
404550556065707580859095
100
1 1.3 1.6 2 2.5
TMP (bar)
Flu
x (
LM
H) 1 GE
1 Pall
1 NS
1 ML
IBC Applications for BiopharmaceuticalsLa Jolla, CA June 1-3 2009
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LaborLabor
ConsumablesConsumables
WorkflowWorkflow
Single Use TFF Applications
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LaborLabor
ConsumablesConsumables
WorkflowWorkflow
Single Use TFF Applications
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Required Steps for TFF process
Set Up
Sanitize
Flush
NWP
Equilibrate
Process
Clean
Flush
NWP
Storage
RE-USABLE TFF
Time
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Required Steps for TFF process
Set Up
Sanitize
Flush
NWP
Equilibrate
Process
Clean
Flush
NWP
Storage
RE-USABLE TFF
Time
Process = 6 hrs
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Required Steps for TFF process
Set Up
Sanitize
Flush
NWP
Equilibrate
Process
Clean
Flush
NWP
Storage
RE-USABLE TFF
Time
Process = 6 hrs
Total Time = 12 hrs
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Process= 6 hrs
Time
Set Up
Equilibrate
Process
Required Steps for TFF process
SINGLE USE TFF
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Required Steps for TFF process
SINGLE USE TFF
Total Time = 7.0 hrs
Process= 6 hrs
Set Up
Equilibrate
Process
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Time Allocation Reusable TFF Process
Time Allocation Single Use TFF Process
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 Savings versus Single Use Cassettes
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Labor
Consumables
Workflow
Single Use TFF Applications
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Consumables Include:
Purified Water
Buffers
Cleaning Solutions
Filtration Cassettes
Developing a Model for Single Use TFF
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Economy of Single Use TFF
75% Less Buffer / WFI Required
230
60
0
50
100
150
200
250
Buffer/WFI Usage
(L/s
q. m
eter
)
Re-useSingle Use
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Consumables Include:
Purified Water
Buffers
Cleaning Solutions
Filtration Cassettes
Developing a Model for Single Use TFF
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Reusable Cassette Suppliers
Single Use – Economics
Average = $4,800 / meter2
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
$3,500
$4,000
$4,500
1$ per sq meter surface area
Supplier A
Supplier B
Supplier C
Supplier D
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80% Less per TFF cassette
Other Supplier Reusable TFF$4,800 per meter2
Single Use – Economics
$4,800
$930
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
$3,500
$4,000
$4,500
1$ per sq meter surface area
Re-useSingle use
TangenX SiusTM Single Use TFF$930 per meter2
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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-LS 0.01 –0.1 m² surface area SiusTM 0.5 –2.5 m² surface area
SiusTM and SiusTM-LS Overview
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NovaSetTM Reusable TFF Cassettes
Direct Scalability – From Single Use to ReusableSame channel geometry (ΔP and crossflow rate)
Same membrane chemistry (Prostream and Hystream)
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Labor
Consumables
Workflow
Single Use TFF Applications
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Reduces validation requirementsReduces validation requirements
Process flexibility Process flexibility
Reduces risk of cross-contaminationReduces risk of cross-contamination
Consistent membrane performance run to runConsistent membrane performance run to run
Removes process bottlenecks – Improves workflowRemoves process bottlenecks – Improves workflow
Other Benefits to Single Use TFF
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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
SiusTM and SiusTM-LS Summary
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SiusTM Cassette Holders & Disposable Flow Path Inserts
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Disposable Flow Path Inserts
Filter Plate Inserts Disposable Flowpath
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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
Disposable Flow Path Inserts
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TSPDI-VXBC: 10 m² up to 30 m² capacity
TFP99-SP20 Filter Plate Insert (150 LPM)
Disposable Flow Path Inserts
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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
Disposable Flow Path Inserts
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Novasep Process: TangenX Tangential Flow Filtration Products 35
Single Use TFF:Case Study
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Novasep Process: TangenX Tangential Flow Filtration Products 36
Michael Xenelis, EMD Serono Biotech Center
IBC Bioprocess International Conference
October 16, 2009
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Novasep Process: TangenX Tangential Flow Filtration Products 37
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Novasep Process: TangenX Tangential Flow Filtration Products 38
Total Process Time = 13.1 Hours
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Novasep Process: TangenX Tangential Flow Filtration Products 39
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Novasep Process: TangenX Tangential Flow Filtration Products 40
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Novasep Process: TangenX Tangential Flow Filtration Products 41
Single Use TFF:Case Study
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Single Use TFF Case Study
Recombinant Protein
500L Batch Size
10X Concentration / 5 volume Diafiltration
Process Flux = 100 LMH
Process Time = 4 Hours
Membrane Area = 2.5 Sq. Meter
Single Use TFF vs. Reusable TFF
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Single Use TFF Case Study
Economic Model
20 runs per year
Membrane costs
Labor and Overhead (validation)
WFI and Buffers
Single Use TFF vs. Reusable TFF
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Single Use TFF Case Study
Membrane Costs
Run # vs. Cassette Cost / Run
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
$8,000
$9,000
$10,000
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Run Number
Cass
ette
Cost
per
Run
Re-Usable
Single Use
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Single Use TFF Case Study
Labor and Overhead
Labor
QA / QC
Validation
Facilities – HVAC, Clean Room
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Single Use TFF Case Study
Labor and Overhead
Labor and Overhead Rate $1,000/hr
hours $ hours $
Set-Up 0.5 $500 0.5 $500Sanitize 0.5 $500
Flush 0.5 $500NWP 0.5 $500
Equilibration 0.25 $250 0.3 $250Process 4.0 $4,000 4.0 $4,000Clean 2.5 $2,500 1.0 $1,000Flush 0.5 $500NWP 0.5 $500Store 0.5 $500
10.25 $10,250 5.75 $5,750
Reusable Single Use
$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000Reusable vs. Single-Use Process Cost
1 2Process Type
Cost
(USD
)
Store
NWP
Flush
Clean
Process
Equili.
NWP
Flush
Sanitize
Set-Up
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Single Use TFF Case Study
Buffer Costs
WFI
Buffer chemicals
Consumables – filters, bags
Labor
QA/QC
Validation
Single Use TFF vs. Reusable TFF
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Single Use TFF Case Study
Buffer Costs
Buffer Cost $1.20 per literProcess Area 2.5 per m2Number of Runs 20 per campaign
Cost per run Total CostRe-Usable $690 $13,800Single Use $180 $3,600
Note: * Buffer cost includes system, maintainance, buffers, raw materials, monitoring, and disposal
Buffer Cost per Campaign
$13,800
$3,600
$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
$16,000
Re-Usable
Single Use
Buffe
r Cos
t (U
SD)
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Single Use TFF Case Study: Summary
Total Cost per Campaign
$0
$50,000
$100,000
$150,000
$200,000
$250,000
1
Tota
l Cos
t
Re-UsableSingle Use
Cost / run Total Cost Cost / run Total CostOverhead & Labor $10,250 $205,000 Overhead & Labor $5,750 $115,000
Buffer Usage $690 $13,800 Buffer Usage $180 $3,600Consumables $500 $10,000 Consumables $2,000 $40,000
TOTAL COST $11,440 $228,800 $7,930 $158,600
Total Savings $70,200
Re-Usable Single Use
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Single Use TFF Case Study: Summary
45% Increase in Productivity
Process Time
10.25
5.75
0
2
4
6
8
10
12
Hou
rs
Reusable
Single Use
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THANK YOU FOR YOUR ATTENTION