The world leader in serving science

Revision date: July 2016

BPD SUT Capabilities

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Premier Brands

• 50,000 employees in 50 countries

• $17 billion in annual revenues

• Unparalleled commercial reach

Unmatched Depth

• Leading innovative technologies

• Applications expertise

• Lab productivity partner

Global Scale

We Are The World Leader in Serving Science

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Analytical Instruments Life Science Solutions

Laboratory Products

and Services

Specialty Diagnostics

GlobalFiler

PCR Amplification Kit

25%

19%

19%

37%

$17B Revenue

Mass

Spectrometry

Q-Exactive HF

mass spectrometer

Chromatography

Vanquish

Ultra HPLC

Chemical and

Environmental Analysis

Gemini handheld

analyzer

Clinical

Diagnostics

Oral-Eze Oral Fluid Collection System

Transplant

Diagnostics

NXType High

Resolution Genotyping

ImmunoDiagnostics

ImmunoCAP Allergy

and Asthma Tests

Microbiology

Antimicrobial Susceptibility Testing Solutions

QuantStudio

Dx R qPCR

Genetic

Sciences

Human

Identification

Sorvall WX+

Ultracentrifuge

Lab Equipment

Lab

Consumables

E1 ClipTip

Pipette

system

Distribution and

BioPharma

Services

Chemicals

Clinical Oncology

Next Gen Sequencing

Our Business Segments

Enterprise and

Instrument

Services

Biosciences

Life Science

Reagents

Pathology

Rotary Microtome

BioProduction

Single-use

Systems

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A Mission We’re Proud of

We enable our customers to make the world healthier, cleaner and safer.

5

Productivity

Improving

Maintaining cGMP

Compliance

Risk

Mitigation of

Supply Chain

Transparency

Discovery

Accelerating

Costs

Reduction of

BioPharma

Industry

A Growing and Changing Biotherapeutics Market

Right the First Time. Every Time.

Quality Continuity of

Supply

BioPharma Industry Challenges

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Freedom™ CHO

cell lines

Analytical services

Media optimization

services

Gibco™ Media

Express™

BioProcess

Containers (BPC)

Single-use mixers,

bioreactors and

fermentors

Transfer assemblies

Inflation and integrity

test system

BioProcess

Containers (BPC)

Harvest and

separation products

Single-use heat

exchanger

Single-use aseptic

sampling system

BioProcess

Containers (BPC)

Single-use mixing

systems

Transfer assemblies

BPCs, manifolds,

containers

Storage and

transport

Single-use filling

system

Frozen Handling

system

Bulk Storage & Final Fill

DOWNSTREAM

Cell Line Development & Media Optimization

QC & Analytics

Mixing, Cell Culture & Fermentation

Harvest & Collection

Purification

UPSTREAM

Microbial identification and Glycan analytics

Sample prep and automation Mycoplasma and viral detection

Analytical columns

Best-in-class solutions for up- and downstream bioprocessing

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Drive Your Supply Chain Confidence

To have your

supplies when

you need them

Business Continuity

Key initiatives…

• Redundancy of manufacturing for key cell culture and single-use products

• Plans for effective prevention and recovery from operational disruption

• All sites Environmental, Health & Safety (EHS) compliant

Safety Stock

• Maintenance of intermediate and finished good safety stocks

• Product can be shipped from our warehouses within 2 days of your request for single-use

• Approximately 5 million liters of finished goods stored each month for cell culture

Demand Planning

• Help eliminate lead times by aligning Thermo Fisher’s production schedule to yours

• Some products can be available 4 weeks prior to your target date

Assurance of Supply

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Auckland and Christchurch,

New Zealand Newcastle, Australia

• Sera

• Protein products

• GMP 21 CFR 820

Cramlington, UK

• Bioprocess containers

• Class 10,000/ISO 7

clean room

Bedford, MA

• Chromatography resins

• ISO 13485

Logan, Utah

• Bioprocess containers

• Single-use technologies

• Class 10,000/ISO 7

clean room

Grand Island, NY

• Cell culture media, reagents

• Sera

• ISO 13485

• GMP 21 CFR 820

Paisley, Scotland

• Cell culture media, reagents

• ISO 13485

• GMP 21 CFR 820

Matamoros, Mexico

• BioProcess

Containers

• ISO 13485

• FDA Registered

Millersburg, PA

• BioProcess Containers

Single-use technologies

• ISO 13485

• FDA Registered

Naarden, The Netherlands

• ISO9001 certified

• Affinity ligands

Warrington, UK

• Analytics kits

Global BioProduction Manufacturing Facilities

Indicates a SUT facility

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The Power of ONE Brand

Company

Name

Premier

Product

Brand

Product

Line

Identifiers

Product

Names

HyPerforma (for legacy Thermo

Fisher hardware)

• Single-Use Mixers

• DS 300

• Single-Use Bioreactors

• Single-Use Fermentors

• Drums

imPULSE, DHX,

Acclimate, inSITE, Precise (for former ASI hardware)

• Single-Use Mixers

• Heat Exchanger

• Frozen Handling System

• Integrity Testing System

• Single-Use Filling System

Aegis5-14, CX 5-14,

ASI 26/77, ASI 28 (for film platforms)

• Labtainer

• Productainer

• Powdertainer

• Harvestainer

• Rock-It

• Transfer

Assemblies

• Manifolds

• Services

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The Power of the Thermo Scientific Brand

Portfolio Options

& Diversity

Assurance

of Supply

Improved

Productivity Innovation

A complete portfolio of best-in-class

hardware including mixers,

fermentors, bioreactors, heat

exchangers, point-of-use integrity

testers and filling systems.

Expansive film and BioProcess

Container (BPC) options to deliver

optimal film and configurations

based on performance, chemical

and biological properties

Opportunity to partner as

qualified primary and secondary

supplier through separate legal

entities with global

manufacturing facilities

Provide manufacturing

redundancy in each of its

bioprocess facilities for all films

A continuous pipeline of

innovative solutions and

capabilities across our wide

range of products and

applications.

Continued investments to

sustain our best-in-class

products with customers’

evolving requirements.

More choices add more

flexibility to customer’s

manufacturing capabilities

Meet customer demand for

both quality and productivity

in bioprocessing

Benefits to our single-use customers

11

Single-use Technology (SUT)

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Films

Film material: CX5-14, Aegis 5-14, ASI 26/77, ASI 28

Sizes: 50 mL to 5,000 L

Surface Area/Volume ratio: Small bags -High SA/V, Large Bags - Low SA/V

Fluid compositions: Media, Buffers, Excipients, Intermediates, Drug products

Fluid Residency Times: Short term to Long term

Temperatures: -80˚C to +60˚C

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Our BioProcess Containers are specifically designed for single-use bioprocessing and

meet stringent quality standards. Due to the film strength, robustness and flexibility, our

BPC are suitable for use in upstream, for cell culture and fermentation, or downstream,

for sophisticated applications or simply as holding and transfer systems in cGMP

bioprocessing facilities.

Benefits:

• Outstanding physical characteristics for superior puncture

resistance and content integrity

• Coextruded structure to minimize delamination potential

• Greater cleanliness and low leachable/ extractable profiles

• Non–animal origin formulations for safer contact surfaces

• High gas- and liquid-barrier properties for better content stability

• Validation packages assurance of product performance

• Sizes ranging from 50mL – 5,000L

Film Excellence - The Reason why Customers Choose Us

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BPC – Standard and Custom Designs

Chambers

•2 D

•3 D

•Manifolds

Specialty

•Powdertainer

•Harvestainer

Storage and Transport

•Drums

•Bins

•Docking Systems

Integrated

•S.U.M.

•S.U.B.

•S.U.F.

•DHX

•Smartainer

Applications

•Media hydration

•Cell Culture

•Harvest

•Freeze / Thaw

•Buffer Prep

Open architecture approach for component customization

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• Manufacturing >1.5 million BPC

chambers annually

• Standard and custom configurations in

as little as 4 weeks

• Powder and liquid handling, incl. liquid

shipping

• Largest standard component library to

• Shorten lead times

• Provide choice and flexibility

• Support highest quality standards

• Multiple manufacturing sites on two

continents

• 97% on-time and in full product delivery

• Quality documentation and validation

guides available

Leading Supplier of 2D & 3D BPC

>20 years developing SUT products specifically for the biopharma industry

Labtainer 50 mL-50 L

BioProcess

Containers 50-3000 L

Complex Manifolds 50-3000 L

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• Standard and custom configurations for

upstream and downstream applications

• Open architecture approach (filters,

sensors, connectors etc.)

• Single-film qualification from

30 L – 5000 L for hardware BPC

• Multiple manufacturing sites on two

continents

• Zero lead time and stocking products

available to guarantee assurance of

supply

• Optional Point-of-Use Integrity Testing

System for any BPC available

• Multiple film options for single-use

hardware systems

Most Widely Used 3D BPC for SUT in the Industry

>20 years developing SUT products specifically for the biopharma industry

Single-Use Bioreactors

& Fermentors 30-2000 L

Single-Use Mixers 50-5000 L

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Your Partner in Single-use Fluid Transfer Assemblies

Your complete end-to-end solution provider

Your trusted guide for single-use technology and applications

• Fastest industry lead times*

• A single point of coordination for

design, manufacturing and service

• Helps reduce your burden of

required equipment and upkeep

• Helps free your personnel for

other crucial activities

• Fluid transfer assemblies are customized

to your existing processes

• Designs accommodate a variety of

components using our open architecture

approach and draw from our qualified

standard components library, the

industry’s largest

• Delivering the benefits of single-use

technology**

3 week lead times for sterilized products

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Single-use Bioreactors

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Single-use Bioreactor BPC

Open pipe sparger Frit sparger

Pressure sensor

Port labeling on bags and cables

Probe belt for classical

& single-use sensors

Optional sample

manifold

Single-use connectors

Drill hole sparger Open pipe sparger

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Two S.U.B. Family Offerings

Open Architecture Thermo Scientific™ S.U.B.

Integrate with the control platform

of your choice

Turnkey Solutions Thermo Scientific™

HyPerforma™ S.U.B. TK

State-of-the-art S.U.B. with integrated

control choices from two suppliers

Choice of leading controller platforms for Turnkey S.U.B.

Scalability from 25 to 2000L

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Single-use Process Analytical Technologies (PAT)

Pressure

Technologies emerging:

CO2

pH

DO

Cell Mass

Metabolites

Technologies available today:

Cutting-edge Technologies

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Single-use Mixing Technologies

• Thermo Scientific HyPerforma Single-use Mixers (S.U.M.s)

• Thermo Scientific imPULSE Single-use Mixers (S.U.M.s)

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imPULSE Core imPULSE Elite imPULSE MDS SUM DS 300 Mixtainer

Description Mixer-Simple Control Mixer-High Control Mixer-Dock-Ship Mixer-Simple

Control Mixer-Dock Mixer-Dock-Ship

Size Range (L) 30 – 10,000L 30 – 10,000L 30, 50 50 – 2,000L 50 – 300 L 50, 100, 200

Linear Scalability Yes Yes Yes Yes Yes Yes

Tank Temperature Control No Jacket Heat No Jacket Heat No No

Bag Auto Inflation and Automatic Vent Control No Yes No No No No

Sensors No

pH, DO, CO2, Temp,

Weight, Conductivity, Fluid

Height

No pH, DO, Temp,

Weight, Pressure No No

Base Mobility Fixed/Casters Fixed/Casters Fixed/Casters Fixed/Casters Casters Casters

Mixing Technology Btm-imPULSE Btm-imPULSE Btm-imPULSE Top Stir Tank Top Stir Tank Btm-Stir Bar

Controls Self sustained e-box e-box e-box, PLC, PC,

Delta V e-box Handheld controls Power, Speed

Minimum Mixing Volume 1% 1% 1% 20% 20% 1%

Drain Location Btm Btm Btm Btm Btm* Btm

Particulate Generation None None None None None Med

FAT/SAT/Service/PM/Validation Support Yes Yes Yes Yes Yes Yes

Fluid Vortex No No No No No No

Tank Materials SST SST SST, Plastic SST Plastic Plastic

Sparge Capable No Yes No Yes No No

Available Mixing Platforms

* - Bottom drain for 50L/100L/200L Drums only and open top drain for 300L Drum

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Single-Use Mixer (S.U.M.):

• 50 L

• 100 L

• 200 L

• 500 L

• 1000 L

• 2000 L

HyPerforma Mixing Solutions

Mixing solutions designed to meet your needs

HyPerforma S.U.M. Animation Video Link

DS 300:

• 50 L

• 100 L

• 200 L

• 300 L

Mixtainer:

• 50 L

• 100 L

• 200 L

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imPULSE Core:

• Superior mixing with basic

controls and monitors

• 30 L

• 50 L

• 100 L

• 250 L

• 500 L

imPULSE Mixing Solutions

imPULSE Elite:

• Flexible platform that is

customized to your process

• 30 L

• 50 L

• 100 L

• 250 L

• 500 L

imPULSE MDS:

• Superior mixing,

modularity with a safe and

secure shipping container

• 30 L

• 50 L

imPULSE Animation Video Link

• 1,000 L

• 2,000 L

• 3,000 L

• 5,000 L

• 10,000 L

• 1,000 L

• 2,000 L

• 3,000 L

• 5,000 L

• 10,000 L

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Single-use Fermentors

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Expanding “Normal” Platform Capabilities

Microbial Production Platforms

• Small, non-glycosylated proteins

• Perceived as low cost

Status Quo

• Each process developed/qualified de-novo

• Carries high risk of failure

• OK 25 years ago… now?

Current Single-use Optimized for

Shear-Sensitive Cell culture

• Low power input, mixing

• Limited oxygen transfer rate (OTR)

• Exhaust management

Modified SUB’s don’t deliver for

demanding fermentation processes

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30 L and 300 L S.U.F.

First Large Scale Single-use Fermentation Solution

Key Features

The S.U.F. is a fully functional fermentor vessel including

single-use sterile contact surfaces for mixing, venting, sparging and

temperature sensing. Additional ports are included to allow choice of

aseptic connections for filling, emptying and sampling.

• Unique proprietary mixing system enables conventional overhead mixing while

maintaining sterility and integrity of the S.U.F. BPC.

• Minimized vessel footprint and reduced hold-up volumes.

• Simplified bag loading with a front access door.

• Side and bottom jacket for effective heat transfer.

• Cable management system offers greater organization

for electrical cables, tubing and line sets while making

the unit easier to clean.

• Dedicated adjustable tool holder keeps necessary tools.

• State-of-the-art foam sensor that helps prevent exhaust

filter failure.

Modified SUB’s don’t deliver for demanding

fermentation processes

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Agitation: Drive Train

3 Rushton Impellers

• Industry standard for rigorous mixing

• Multiple impellers increase mixing distribution

• Generates mixing shear and bubble breakup

4 Baffles

• Breaks up vortex of center driven mixer

• Converts some radial mixing to vertical

Powerful Mixing

• 100x the nominal power of traditional S.U.Bs

• 2.27W/L (11hP/1000gal)

Low Volume Mixing

• 5:1 turn down ratio (supports full RPM range)

• 30L S.U.F. (6L min), 300L S.U.F. (60L min)

Volume flexible, high power, uniform mixing

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Storage and Transport Solutions

31

HyPerforma Smartainer Systems – Stainless Steel

Key Advantages

• Thermo Scientific™ HyPerforma™ Smartainer™ systems have

chambers constructed of Thermo Scientific Aegis5-14 Film and

CX5-14 Film with dimensions optimized for Smartainer systems.

• Smartainer systems are simple, durable and economic containers

constructed in 304 stainless steel.

• They are intended for in-house handling applications in critical areas.

• Smartainer systems are non-jacketed outer container systems

available in unit volumes of 200, 500, 1,000, 1,500 and 2,000L.

• It is a modular system with optional accessories for mobility and BPC

handling.

• Jacketed versions available in all sizes on a custom basis, for

applications where heating or cooling are required.

• Smartainer systems are designed to allow both top and bottom

discharge from BPCs.

• Standard BPC configurations are available in unit volumes of 100,

200, 500, 1,000 and 1,500L.

• Wide configuration available for 1,000 L – 1,500 L using only the

ASI 26/77 film

32

Key Advantages

• Standard sizes (100 L – 1,000 L)

• Ease of use and operation

• Clean room grade swivel casters and wide

configurations (available up to 1,000 L)

• Smooth, clean room grade plastic

Accent Outer Support Containers - Plastic

Choose from a comprehensive line of economical, standard or fully customizable

containers to best fit a variety of applications. There are also standard 3D BPCs

for each size, material and configuration with standard port configurations.

33

DHX Heat Exchanger

• A modular heat exchanger that employs a plate and frame concept,

using a single-use BPC as the sterile fluid path.

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DHX Heat Exchanger

Features and Benefits

• Single-use, sterile fluid path

• Completely isolated flow paths for process and heat

transfer fluid

• Small and modular footprint

• Easy to integrate in new or existing processes

• Dimpled jacketing on plates provide turbulent flow

• BPCs fill in place with little operator interaction

• Reduced infrastructure requirements

• Reduced processing time

• Adaptable to your unique process

DHX Overview Video Link

35

DHX Heat Exchanger

Single-use BPC Assembly

• Single-Use BPC Material of construction:

low density polyethylene (ASI 26/77 film)

• Interconnecting tubing: C-Flex

• Pressure/temperature rating (Installed in

DHX plate system): 20 PSIG at 122˚F (50˚C)

• Open architecture connections and assemblies

• Flow rate capacity: Up to 15 Liters per Minute (LPM)

36

inSITE Integrity Testing System

• inSITE is the only true point-of-use integrity testing system that allows users to confirm the

integrity of single-use bags inside the tank that is about to be filled.

37

inSITE Integrity Testing System

Advantages

Using sterile air, the system inflates bags to a precise

pressure within the container and monitors for pressure

decay that would indicate a leak. Both gross and fine flaws

can be detected in any type of bag.

• Multichannel, point-of-use integrity testing

• Gross and fine leak detection

• Guided validation setup

• Tests BPCs up to 5,000 L

• Inflation procedure improves loading and

placement in tanks

• Liquid filling cycle regulates internal

pressure while fluid is being introduced

inSITE Overview Video Link

38

Acclimate Frozen Handling System

• The Acclimate system is a single-use Bioprocess Container (BPC) and shell combination

used for freezing and thawing bio-pharmaceutical fluids in commercial equipment such as

walk-in freezers, cold rooms, temperature controlled cabinets or water baths.

39

Acclimate Frozen Handling System

Features and Benefits

• Integral BPC and shell in sizes:

2, 6, 12 or 16 Liters

• Easily fits and Stacks in Commercial Freezing

Equipment

• Optional Sample BPC

• Capable of Withstanding Temperatures as low

as -80˚C and thaw conditions to ambient room

temperature and maintaining integrity.

• Pre-assembled

• Compact and Durable Design

• Single-Use

• Pre-sterilized and ready to use

Uniform Fluid Distribution Design

• The acclimate BPCs are designed with patent-pending

tuft(s) which help distribute the fluid during filling then

holds the fluid in a uniform manner as it expands

during freezing

40

Three60 Single-use Sampling System

• The simple design behind the three60 sampling system allows you to take a representative

sample of your product with minimal effort.

41

Three60 Single-use Sampling System

Kit to Tank

The Three60 is pre-irradiated and assembled into a

one-piece kit. Simply remove the pre-sterilized device from the

kit and apply to the vessel.

• 1: Quick Turn three60 Valve

The face of the three60 valve can be sterilized with the tank through

traditional CIP / SIP processes. The valve has four sterile assemblies.

This keeps the product and technician contaminate free.

• 2: Pinch and Cut Sterile Disconnections

The Pinch and Cut Disconnections allow you to quickly separate the sample

and eliminates the need for tools or tube sealing.

• 3: Injection Ports

Luer lock injection site. Extract through either the septum or twist-off

luer to pour.

• 4: Pre-Irradiated Bag Sets

ASI provides pre-irradiated bag sets in sizes ranging from 50 ml to 2 Liters.

1

2

3

4

Three60 Animation Video Link

42

Precise Single-Use Filling System

• A small, modular machine that employs disposable tubing assemblies and BPCs to create a

clean and efficient method of filling BPCs.

43

Types of Precise filling systems

Manual Semi-Automatic Semi-Automatic with Integrated Weight Scale

Advantages Manual Operation

Utilizes off-the-shelf

peristaltic Pump for

volumetric metering

Semi-automated

operation

Utilizes off-the-shelf

peristaltic pump for

volumetric metering

Foot Pedal

Operation

Fill Accuracy +/- 2 ml

Programmable Weighing Terminal for

product ID storage

Per batch calibration is NOT required

Variable Fast Feed/Slow feed selection

Several programming features including

Auto learn (if required)

Challenges Manual Operation

Fill Accuracy ≥ 2%

Must be calibrated

per batch

Fill Accuracy ≥ 2%

Must be calibrated

per batch

Depending on size of BPC and precise

accuracy of the fill, fill times may be slower

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• The Precise Filling Connector is an integral part

of the pre-irradiated BPC.

• Simply place the BPC and connector assembly

into the cradle and operate the handle or foot

pedal. The filling machine will remove the cap,

fill to the desired volume and replace the cap

into the final closed position

• The fill connector is a high throughput fluid path

and is standard across all BPC sizes (100 mL,

250 mL, 500 mL, 1 L, 2 L, 5 L, 10 L, 20 L)

BPC and equipment interface

45

Case Study

Conversion of a Traditional Facility Into a Flexible Facility

Situation Our Response Value Delivered

• Customer’s choice between

investment in additional stainless

steel facility or SUT

• High upfront cost for Stainless

Steel systems

• Long set up times & down times

during change-over

• Difficult to change when market

conditions change

• Introduced 500L S.U.B.

• Installed 2000L S.U.B.

in phase 2

• Worked with customer to optimize

operating conditions

to maximize titers

• Customer experienced 85%

reduction in capital equipment

investment

• 2000L S.U.B. performance closely

matches performance at bench

and 500L scale

• Ability to build out smaller

footprint facility

• Simplified personnel and

material flow

46

Case Study

Increased Productivity & Reduction in Capital Investment

Situation Our Response Value Delivered

• A large Animal Health company is

using micro carriers

• But it’s very difficult to remove

from stainless steel parts

(i.e., impeller and various ports)

• In a single-use bioreactor, this

difficulty is resolved as all micro

carriers from the previous

production are disposed.

We were selected based on the

following:

• SUT construction materials, like

bag sterility, splash proof,

resistant to routinely used

disinfection methods

• Reliability and maintenance of

products

• Meeting critical control

parameters, like pH, dO2,

stirring speed

• Architecture incl. volume range,

dimensions (500L S.U.B.)

• > 80% capital investment saving

compared to purchase of

stainless steel system

• Virus yields in the 250L S.U.B.

are equal or better than the ones

obtained in reference bioreactors

47

Your Team

BioProduction Account Manager

Single-Use Cell Culture Purification Analytics

• Sales

Name:

Contact:

• Technical Expert (FAS)

Name:

Contact:

• Sales

Name:

Contact:

• Technical Expert (FAS)

Name:

Contact:

• Sales

Name:

Contact:

• Technical Expert (FAS)

Name:

Contact:

• Sales

Name:

Contact:

• Technical Expert (FAS)

Name:

Contact:

48

The world leader in serving science

© 2016 Thermo Fisher Scientific Inc. All rights reserved. All

trademarks are the property of Thermo Fisher Scientific and its

subsidiaries unless otherwise specified.