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LEWA Bioprocess Technologies –Overview of TFF Systems
LEWA Center Of Excellence for High Purity - Devens, MA, USA
LEWA Bioprocess Technologies – Filtration expertise
LEWA Systems’ Capability
1/5/2017© LEWA.
2
LEWA ecofoam®
System for metering various blowing
agents in plastic manufacture in
combination with extruders
LEWA EcoPrime®
Chromatography (LPLC & HPLC) systems
with innovative, mechatronic drive and
hygienic diaphragm metering pumps
LEWA odorizing system
LEWA has built odorizing systems for over
40 years, e.g., for natural gas, oxygen,
nitrogen and carbon dioxide
Buffer Inline Dilution
System to mix all ingoing fluids, e.g. prior
to a chromatography system
Nitrogen Generation
Industry-scale, custom-designed
membrane-type package with very low
lifecycle costs
LEWA ISO 5 Station
Designed in concert with customer for bulk
drug substance bottling in an ergonomic
and high purity environment
Chemical Injection Package
Customer specific packages for
chemical injection in the oil and gas
industry
LEWA Bioprocess ProductLEWA Bioprocess Product
LEWA Bioprocess Product
LEWA Bioprocess Product
Membrane Systems
Systems designed and fabricated for clients in
biopharm industry using any suppliers cassette
or cartridges
Downstream Systems by LEWA
1/5/2017LEWA Bioprocess Technologies, Inc. 3
LEWA Process Technologies, Inc. - Products & Services
Developing and Supplying High Purity Systems to Global Biopharma Customers
MF Hollow
Fiber
Clarification
Systems
UF/DF
Cassette
Systems
Automation /
Software /
Controls
Buffer In Line
Dilution
Systems
LPLC / HPLC
Chromatography
Systems
ISO 5
Bottling
Station
Our Offerings
Custom TFF
Specialists.
We design Custom UF and MF
TFF systems based on flat
sheet cassette or hollow fiber
modules.
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LEWA TFF Systems using cassette or hollow fiber formats
Major biopharma’s and OEM both have come to LEWA
for TFF system design.
LEWA remains neutral to a specific membrane style –
giving customers what is optimum for their TFF process.
1/5/2017© LEWA GmbH, 5
TFF: LEWA TFF Cassette System for Process Development
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USA (Biopharma Process
Development facilities).
Delivered 2014
Location
Application
Multiple purification processes in
addition to the TFF skid were
developed for processing of
protein based therapies under
development.
LEWA Process Technologies
original design in concert with
major biopharmaceutical
company. LPT automation,
system design and manufacture.
LEWA solution
TFF Cassette
Custom UF /
TFF with
controls and
tank by LEWA
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UF (TFF) Control Panel
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Application Example: TFF
Ultrafiltration Processing System
1/5/2017© LEWA Bioprocess Technologies, Inc. - Confidential9
EU, USA, Asia (Multiple
Biopharma Facilities).
Delivered series of units starting
2008
Location
Application
Hollow Fiber Membrane
production skid for GMP
production.
LEWA OEM design for major life
sciences technology supply
company. LEWA Process
Technologies design and
manufacture based on OEM
supplied concept.
LEWA solution
Application Example: Membrane Purification System
1/5/2017© LEWA Biorocess Technologies, Inc 10
USA (Biopharma Facilitiy).
Delivered 2011
Location
Application
Hollow Fiber Membrane
production skid for GMP
production.
LEWA original design for major
biopharmaceutical company.
Employed LEWA EcoDos pumps
with system design and
manufacture by LPT.
LEWA solution
Application Example: Membrane Purification System
1/5/2017© LEWA Biorocess Technologies, Inc 11
USA (Biopharma Facilitiy).
Delivered 2010
Location
Application
Hollow Fiber Membrane
production skid for GMP
production.
LEWA original design for major
biopharmaceutical company.
Employed Fristam pumps with
system design and manufacture
by LPT.
LEWA solution
Hollow Fiber Fit
Up Modules
Shown on Skid
1/5/2017© LEWA Process Technologies, Inc. 12
Application Example: Cassette Membrane Purification System
USA (Biopharma Facilitiy).
Delivered 2009
Location
Application
Flatt Sheet Cassette Membrane
production skid for GMP
production.
LEWA original design for major
biopharmaceutical company.
System design and manufacture
by LPT.
LEWA solution
Recent Simple UF System: Manual Control
1/5/2017 13
Complex UF TFF Skids – No Problem!
1/5/2017© LEWA Process Technologies, Inc 14
Complete System
Design and
Manufacture to
Support TFF Systems
1/5/2017© LEWA Biorocess Technologies, Inc. 15
Photo Example:
LEWA designed and manufacture
of TFF system supply tank and
controls
Application Example: MF (dead end) Purification Systems by LEWA
1/5/2017© LEWA Process Technologies, Inc. - Confidential 16
USA (Biopharma Facilities).
Multiple Skids
Location
Applications
Clarification and sterile filtration
using MF cartridges from major
suppliers skid for GMP production.
LEWA original design for major
biopharmaceutical companies.
LEWA solution
The Characteristics of Tangential
Flow Membranes.
1/5/2017© © LEWA Biorocess Technologies, Inc 17
Cross Flow Filtration
Tangential Flow Filtration (TFF)
– Higher filtering capacity than
dead end filters (MF cartridges)
– Most commonly used for cell
harvest, protein concentration,
desalt, buffer exchange, etc.
– Complex process control
Cross Flow
Permeate Flow
Tangential Flow Filtration
Feed (PF)
Retentate (PR)
Permeate (Pf)
Membrane
Tangential
flow
Flux
Crossflow/Shear Rate and Delta P
Cross Flow/Shear Rate is:
– The flow that crosses through membrane surface. It typically
refers to the retentate flow, not the feed flow.
– Tangential Flow (or “Cross flow) cleans the membrane surface
in order to prevent membrane fouling.
– Higher crossflow is needed for dirty sample solutions, and
zero cross flow represent the condition of dead end filtration.
Delta P is:
– The pressure difference between feed and retentate.
– Delta P determines cross flow.
– Crossflow and flow channel height determine shear rate.
Crossflow and Delta P
0
500
1000
1500
2000
0 15 30 45 60 75
Delta P (psi)
Cro
ssflow
(m
l/m
in)
Water
Sample Solution
Flux and TMP
Permeate Flow (Flux) is:
– The flow that passes through membrane.
– It is typically presented in LMH (Liter/M2/Hour).
– Flux is usually higher for clean sample solutions than
dirty sample solution.
– In practice, flux is usually declined with processing time,
but sharp flux decline usually indicates insufficient cross
flow (membrane fouling or gel layer formation).
TMP is:
– The trans-membrane pressure.
– The permeate pressure should be zero unless a half of
the minimum delta P is higher than the required TMP.
Flux and TMP and Cross Flow
0
150
300
450
600
0 15 30 45 60 75
TMP (psi)
Flu
x (
LM
H)
Water
Sample Solution
CF2 (CF1)
CF1
Cross Flow Filtration
FLUX Vs. PROCESSING TIME
0
50
100
150
200
250
0 1 2 3 4 5 6
Time (min)
Flu
x (
LM
H)
Work Flow For LEWA Process Technologies - our Strength, Your Benefit
LPT maintains a full compliment of departments that ensure the project has the right resources
1/5/2017© LEWA Process Technologies, Inc. 25
A clear differentiator from
other ”suppliers”.
– Complete array of expertise
to ensure comprehensive
management of the design
– Process experts at each
step.
Process Engineering
Mechanical/Design/CAD Engineering
Automation Engineering
Manufacturing / Fabrication
1
2
3
Project Mangement
QA/QC
Constant Customer Interface
Field
Installation /
Service
4
Subject
Matter
Experts
FAT & Production Facilities
A well equipped FAT (Factory
Acceptance Test) area is an
integral part of LEWA Process
Technologies manufacturing
center of excellence.
1/5/2017© LEWA Process Technologies, Inc. 26
FAT Area
Manufacturing Area
Characterization Laboratory
LEWA Process Technologies
has dedicated space and
resources to characterize our
products for the intended
application.
1/5/2017© ©LEWA Biorocess Technologies, Inc 27
Downstream Expertise.
1/5/2017© LEWA Biorocess Technologies, Inc. 28
LEWA Process Technologies
understands downstream and creates
value through reduction in footprint,
batch to batch reproducibility and
precision that results in yield
improvement.
Ingenuity with process integrity is our
commitment.
Thank you!
Visit www.lewapt.com for more information on
LEWA Bioprocess Systems.
Join us on
LEWA, Creating Fluid Solutions, the LEWA logo, LEWA Intellidrive and LEWA EcoPrime are trademarks of LEWA GmbH.
All goods and services are sold subject to the terms and conditions of sale of the company within LEWA which supplies them.
A copy of these terms and conditions is available on request. Contact your local LEWA representative for the most current
information.
© 2017 LEWA Process Technologies – All rights reserved.
For more information: www.lewapt.com
Headquarters LEWA GmbH
Ulmer Str.10
71229 Leonberg GERMANY
Tel: +49 7152 14-0
Fax: +49 7152 14-1303
LEWA Biosystems Production Facility
8 Charlestown Road
Devens, MA 01434 USA
Tel: +978 487 1100
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150-6022 Tokyo
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Fax: +1 508 429-8615
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