LEWA Bioprocess Technologies Overview of TFF Systems

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1 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 LEWA Bioprocess Product Chemical Injection Package

for chemical injection in the oil and gas industry Chromatography (LPLC &

blowing agents in plastic manufacture in combination with extruders LEWA

Designed in concert with customer for bulk drug substance bottling in an

Industry-scale, custom-designed membrane-type package with very low

2 LEWA Systems Capability LEWA Bioprocess Product Chemical Injection Package LEWA EcoPrime LEWA odorizing system LEWA ecofoam Customer specific packages for chemical injection in the oil and gas industry Chromatography (LPLC & HPLC) systems with innovative, mechatronic drive and hygienic diaphragm metering pumps LEWA has built odorizing systems for over 40 years, e.g., for natural gas, oxygen, nitrogen and carbon dioxide System for metering various blowing agents in plastic manufacture in combination with extruders LEWA ISO 5 Station Nitrogen Generation Buffer Inline Dilution Membrane Systems Designed in concert with customer for bulk drug substance bottling in an ergonomic and high purity environment LEWA Bioprocess Product LEWA. Industry-scale, custom-designed membrane-type package with very low lifecycle costs System to mix all ingoing fluids, e.g. prior to a chromatography system LEWA Bioprocess Product Systems designed and fabricated for clients in biopharm industry using any suppliers cassette or cartridges LEWA Bioprocess Product 1/5/2017 2

3 Our Offerings Downstream Systems by LEWA 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 LEWA Process Technologies, Inc. - Products & Services Developing and Supplying High Purity Systems to Global Biopharma Customers LEWA Bioprocess Technologies, Inc. 1/5/2017 3

4 Custom TFF Specialists. We design Custom UF and MF TFF systems based on flat sheet cassette or hollow fiber modules. LEWA GmbH 1/5/2017 4

LEWA TFF Systems using cassette or hollow

5 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. LEWA GmbH, 1/5/2017 5

protein based therapies under development.

6 TFF: LEWA TFF Cassette System for Process Development Location USA (Biopharma Process Development facilities). Delivered 2014 Application Multiple purification processes in addition to the TFF skid were developed for processing of protein based therapies under development. LEWA solution LEWA Process Technologies original design in concert with major biopharmaceutical company. LPT automation, system design and manufacture. TFF Cassette LEWA Bioprocess Technologies, Inc. 1/5/2017 6

7 Custom UF / TFF with controls and tank by LEWA LEWA 1/5/2017 7

8 UF (TFF) Control Panel LEWA GmbH, LEWA Imagepresentation, v1.0 1/5/2017 8

9 Application Example: TFF Ultrafiltration Processing System Location EU, USA, Asia (Multiple Biopharma Facilities). Delivered series of units starting 2008 Application Hollow Fiber Membrane production skid for GMP production. LEWA solution LEWA OEM design for major life sciences technology supply company. LEWA Process Technologies design and manufacture based on OEM supplied concept. LEWA Bioprocess Technologies, Inc. - Confidential 1/5/2017 9

Application Example: Membrane Purification System Location USA (Biopharma Facilitiy). Delivered 2011 Application Hollow Fiber Membrane production skid for GMP production.

10 Application Example: Membrane Purification System Location USA (Biopharma Facilitiy). Delivered 2011 Application Hollow Fiber Membrane production skid for GMP production. LEWA solution LEWA original design for major biopharmaceutical company. Employed LEWA EcoDos pumps with system design and manufacture by LPT. LEWA Biorocess Technologies, Inc 1/5/

LEWA solution Hollow Fiber Fit Up Modules Shown on Skid LEWA original design for major

11 Application Example: Membrane Purification System Location USA (Biopharma Facilitiy). Delivered 2010 Application Hollow Fiber Membrane production skid for GMP production. LEWA solution Hollow Fiber Fit Up Modules Shown on Skid LEWA original design for major biopharmaceutical company. Employed Fristam pumps with system design and manufacture by LPT. LEWA Biorocess Technologies, Inc 1/5/

Application Example: Cassette Membrane Purification

Delivered 2009 Application Flatt Sheet Cassette Membrane

LEWA solution LEWA original design for major

12 Application Example: Cassette Membrane Purification System Location USA (Biopharma Facilitiy). Delivered 2009 Application Flatt Sheet Cassette Membrane production skid for GMP production. LEWA solution LEWA original design for major biopharmaceutical company. System design and manufacture by LPT. LEWA Process Technologies, Inc. 1/5/

13 Recent Simple UF System: Manual Control 1/5/

14 Complex UF TFF Skids No Problem! LEWA Process Technologies, Inc 1/5/

15 Complete System Design and Manufacture to Support TFF Systems Photo Example: LEWA designed and manufacture of TFF system supply tank and controls LEWA Biorocess Technologies, Inc. 1/5/

sterile filtration using MF cartridges from

16 Application Example: MF (dead end) Purification Systems by LEWA Location USA (Biopharma Facilities). Multiple Skids Applications Clarification and sterile filtration using MF cartridges from major suppliers skid for GMP production. LEWA solution LEWA original design for major biopharmaceutical companies. LEWA Process Technologies, Inc. - Confidential 1/5/

17 The Characteristics of Tangential Flow Membranes. LEWA Biorocess Technologies, Inc 1/5/

commonly used for cell harvest, protein concentration, desalt,

18 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. Cross Flow Complex process control Permeate Flow

19 Tangential Flow Filtration Feed (P F ) Membrane Tangential flow Retentate (P R ) Flux Permeate (P f )

20 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.

21 Crossflow (ml/min) Crossflow and Delta P Water 1000 Sample Solution Delta P (psi)

22 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.

23 Flux (LMH) Flux and TMP and Cross Flow Water CF 2 (CF 1 ) Sample Solution CF TMP (psi)

24 Flux (LMH) Cross Flow Filtration 250 FLUX Vs. PROCESSING TIME Time (min)

Work Flow For LEWA Process Technologies - our Strength, Your Benefit LPT maintains a full compliment of departments that ensure the project has

Constant Customer Interface Manufacturing / Fabrication Complete array of expertise to ensure comprehensive management of the design Process

25 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 A clear differentiator from other suppliers. Constant Customer Interface Manufacturing / Fabrication Complete array of expertise to ensure comprehensive management of the design Process experts at each step. Project Mangement Subject Matter Experts 4 Field Installation / Service 3 QA/QC 2 Automation Engineering 1 Mechanical/Design/CAD Engineering Process Engineering LEWA Process Technologies, Inc. 1/5/

Technologies manufacturing center of excellence.

26 FAT & Production Facilities A well equipped FAT (Factory Acceptance Test) area is an integral part of LEWA Process Technologies manufacturing center of excellence. Manufacturing Area FAT Area LEWA Process Technologies, Inc. 1/5/

27 Characterization Laboratory LEWA Process Technologies has dedicated space and resources to characterize our products for the intended application. LEWA Biorocess Technologies, Inc 1/5/

28 Downstream Expertise. 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. LEWA Biorocess Technologies, Inc. 1/5/

29 Thank you! Visit for more information on LEWA Bioprocess Systems. Join us on

30 For more information: America s Europe Asia LEWA-Nikkiso America, Inc. 132 Hopping Brook Road MA Holliston Tel: Fax: sales@lewa-inc.com Headquarters LEWA GmbH Ulmer Str Leonberg GERMANY Tel: Fax: lewa@lewa.de NIKKISO CO. LTD. Yebisu Garden Place Tower 22nd Floor 20-3, Ebisu 4-Chome, Shibuya-ku Tokyo Tel: Fax: 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 LEWA Process Technologies All rights reserved. LEWA Biosystems Production Facility 8 Charlestown Road Devens, MA USA Tel: sales@lewapt.com

Welcome to LEWA Process Technologies, Inc.

Welcome to LEWA Process Technologies, Inc. LEWA Center Of Excellence for High Purity Devens, MA LEWA Process Technologies; LEWA PT Business Overview.. Version 2015 Rev. 7 Agenda Corporate Structure Main