Next Generation Biomanufacturing Services

to Accelerate Your Project Portfolio

 Process Expertise for Your BioManufacturing Projects
Integrated Solutions designs and implements rapid and
cost-effective biomanufacturing processes – enabling your
project to move seamlessly from process development
to clinical through to commercial manufacturing!
Integrated Solutions is capable of providing fully
single-use, hybrid or traditional stainless steel systems
that fulfill your unique manufacturing requirements.

How Do We Create Value to Our Customers?

Early phase consultancy and process development services
Facility and conceptual layout capabilities
Facility cost estimation capabilities
Proce
Devel
Feasibility studies
Servic
Implementation support that includes risk assessment,
design specification & qualification, Factory Acceptance Test,
Site Acceptance Test, operator trainings etc.
Continued Service
and Support

Integ
Solut
Single-use
Post-Viral FlexAct®
Pre-Viral Technology
Bioreaction | Harvest
Process
Media | Buffer Prep.
and Eng

Support Room
 Integrated Solutions Centres of Excellence (COE)
Sartorius Stedim Biotech is the recognized world leader in the
design and manufacture of upstream and downstream bioprocess
systems. Our COEs in bioprocess engineering are located
in Guxhagen, Germany and Bangalore, India.
At these location Sartorius designs and manufactures
state-of-the-art bioprocess equipment for both
single-use and reusable applications.

ss
opment
es

Platform
Processes

rated
ions
Process
& Cost
Modelling

Design
ineering

Bangalore, India,
Single and Multi-use COE

Guxhagen, German
Single and Multi-use COE
Process Development Services
Sartorius Process Development Consultants help to shorten
the development and tech transfer timeline for successful cGMP
manufacturing of biologics and deliver the most highly optimized
processes. They act as a single point of contact and advise you
on the use of technologies from across our portfolio to develop
scalable, fully characterized, and robust processes early
in the drug development cycle.
We have the most complete set of technologies and analytical
tools for rapid Upstream Process Development. The ambr® systems
enable High Throughput clone screening, selection as well as
media development and are fully scalable to our range of
manufacturing-scale single-use bioreactors.

DoE HTS
Platform Multi-modality
Manufacturability Single-use Process and Cost Modelling

Cell Line Media Process Analytical Assays Bioreactors Scale-up

Technology

Upstream Process

Speed up your Research with Essen & Intellicyt HTS tools  AT tools and BioAnalytical services to assess
P
Assess CQA’s with BioAnalytical services from BioOutsource Process & Product Quality

Cellca CLD, cell banking & BioOutsource Biosafety services HTS PD tools create robust design space

S ensors, analyzers & QbD/MVDA software for extensive DoE Geometrically scalable bioprocess PD portfolio
and process parameter development

PDC = Process Development Consultants HTS = High Throughput Screening DoE = Design of Experiments PAT = Process Analytical Technologies
 Process
Development
Services
Continued
Platform
Service and
Processes
Support
Integrated
Solutions
Single-use Process
FlexAct® & Cost
Technology Modelling

Our Process Development Consultants will help you choose the Process Design
right up- and downstream process for your product. They support and Engineering
you in anticipating lab to commercial challenges, by helping
you scale your upstream process, select scalable single-use,
downstream technologies and using COG process modelling.
The Process Development Consultants will increase process safety
by implementing novel technologies for quantitative virus
and contaminant clearance.

Biosafety

14 months Bioanalytical
Testing
DNA 4 months USP Process

Clone Confirmation DSP Toxicology Clinical

Transfection Stable Pools Clone Picking Cell Banking
Evaluation Run Development Products Products

E arly material availability helps to frontload DSP Material for DSP DSP Toxicology Clinical
dev. and non generic assay development Development Development Products Products

BioOutsources’ 100+ off the shelf Bioanalytical assays combined

is part of the
with Cellca’s world leading cell line development capabilities can
Sartorius Stedim Biotech Group help you speed up your early stage process development.

Quick and Robust Clinic-ready Process

 ellca CLD services scale into a clinic-ready upstream process
C S calable manufacturing scale portfolio complete with single-
in 4 months use sensors, PAT tools and FlexAct® automation platform
Speed up DSP development through early availability Flexsafe® single-use film offers greatest robustness,
of material from stable pools quality assurance and supply chain security.
BioOutsource cell banking, biosafety and bioanalytical services
complement an IND enabling package.
k Reliable, quick & industrially relevant scale-up
 Platform Processes
The biopharmaceutical industry can reduce the time and
cost required to bring products to the clinic and then the market
by taking advantage of our single-use production platforms.
Our process platform team is supporting customers with the
selection of technologies that will deliver the next generation
of biomanufacturing processes integrating innovative solutions
from across the Sartorius portfolio for mAb, rP, ADC, and Viral
modalities.
Modality Lifecycle Platforms accelerate process development
as they provide for robust, scalable and cost efficient processes
that bring molecules into the clinic quickly. Sartorius can
expedite the engineering of single-use and hybrid processes for
scale-up during late stage activities using process templates that
reduce design costs, increase standardization and allow firms to
construct facilities in the shortest possible time. As the underlying
technologies and approaches can be integrated into a platform,
the value gets multiplied over multiple molecules.

Upstream Process – Viral Vectors

Cell Bank
® ®
Single-use Flexel  | Flexsafe  |
mixing systems Flexboy® Bags BIOSTAT® B – RM or BIOSTAT® STR and kSep® Systems Sartoclear® Sartopure®
UniVessel® BioPAT® Viamass

Sartorius Palletank® Sartorius

Media for Storage Filter Range
Seed Expansion Virus Propagation Optional Cell Removal
- Microcarrier Removal
- Cell Iysis
Media Preparation Medium, Feeds
ViroCyt® Analytics

ViroCyt®

Downstream Process – Viral Vectors Process controlled

and monitored
via FlexAct®

Monitoring

Sartorius Pre- |  Sartocon® Sartobind® Sartobind® Sartocon® Sartorius Pre- | 

Final Filters Final Filters

Bulk Harvest Clarification Concentration Capture Polishing Buffer Exchange Sterile Filtration

Buffer Preparation Buffer

ViroCyt® Analytics

FlexAct® BP Palletank® Sartorius Single-use

for Storage Filter Range mixing systems
ViroCyt®
 Process
Development
Services
Continued
Platform
Service and
Processes
Support
Integrated
Process & Cost Modelling Solutions
Single-use Process
FlexAct® & Cost
Technology Modelling
Sartorius will map your process with you by assessing process
inputs (titer, volume, yield etc.) to ensure appropriate equipment Process Design
selection and apply cost analysis and throughput modelling tools and Engineering
to better understand the impact of process design and technology
choices on overall process and facility throughput and Cost
of Goods.

Lifecycle planning: Sartorius uses process & cost modeling tools

to better understand the impact of process design and technology
choices on overall process and facility throughput and Cost of
Goods.

Scenario analysis: process-modelling experts help you determine

which technologies will provide the highest overall performance
and the lowest COGS for your process. They can use these tools
to determine whether you have a commercially viable process
or predict the impact of switching to alternative process
configurations.

Our process-modelling experts have received the highest levels

of training and have gained significant experience through
successfully delivering many diverse projects all over the world.

Cost Analysis at Throughput Kg/Yr Difference in Cost of Goods for a mAb Process
10,000 Batch (USD/Yr)
20,000,000 Ca
Continuous (USD/Yr) M
8,000
Cost ($/Yr) × 10000

Perf-Batch
15,000,000 Co
Cost of Goods (€)

Batch-ContDSP La
6,000
ConcFedBatch-ContDSP Ot
10,000,000
4,000 To

5,000,000
2,000

0 0
10 50 100 200 500 1000 2000 Stainless Steel Hybrid Single Use
Throughput Kg/Yr Type of System

r Difference in Cost of Goods for a mAb Process

Batch (USD/Yr)
20,000,000 Capital
Continuous (USD/Yr) Materials
Perf-Batch
15,000,000 Consumables
Cost of Goods (€)

Batch-ContDSP Labor
ConcFedBatch-ContDSP Other
10,000,000
Total

5,000,000

0
500 1000 2000 Stainless Steel Hybrid Single Use
g/Yr Type of System
 Process Design and Engineering
Our team of engineers develop the layout, workflow and design
of your process and the automation infrastructure based on
your single-use or stainless equipment selection. In parallel
to your facility build, we design, test and qualify all technologies
used within your process, thus significantly improving your
speed-to-market.

We have experience in bioprocess design and engineering,

having implemented a wide variety of products and processes
at different scales. With over 200 successful process implementa-
tions we understand the implications of process strategy and
technology selection on single-use bioprocess design.

Level of Pre-Concept
Basic Detailed Execution, FAT, Consumables Long-term
Partnership & Conceptual
Design Phase Design Phase Installation & Services Collaboration
Agreement Design Phase
 Process
Development
Services
Continued
Platform
Service and
Processes
Support

Single-use FlexAct® Technology

Integrated
Solutions
Single-use Process
FlexAct® & Cost
Technology Modelling
The New Benchmark for Operational Flexibility
FlexAct® systems allow you to custom-configure single-use Process Design
solutions for bioprocessing steps. They consist of a central and Engineering
operating module that offers the widest variety of configuration
options so that you can take complete control of your bioprocess.
Sartorius offers FlexAct® systems for the following process steps.

FlexAct® MP: Single-use Technology for Media Preparation

FlexAct® MF: Single-use Technology for Media Fill
FlexAct® BP: Single-use Technology for Buffer Preparation
FlexAct® CH: Single-use Technology for Cell Harvest
FlexAct® VI: Single-use Technology for Low pH
Virus Inactivation
FlexAct® VR: Single-use Technology for Virus Filtration
F lexAct® UD: Single-use Technology for Ultrafiltration
& Diafiltration

Multipurpose FlexAct® systems are available, the design

of which takes into account the specific requirements of your
biomanufacturing process.
Continued Service and Support
To keep your biopharmaceutical process robust and reliable,
we provide a comprehensive range of services to ensure
the highest reliability and uptime of your equipment, regulatory
compliance and best quality of results. Our worldwide service
network can provide you with rapid support with activities
ranging from installation qualification through to regular
preventative maintenance.
Service Contracts for the Entire System Lifecycle
With our Bioprocess Service Program, Sartorius offers service
contracts to protect your equipment through its entire lifetime.
Based on your specific risk assessment and requirements,
you can choose between three Service Level Agreements:
Essential, Advanced and Comprehensive.
To ensure maximum productivity and lowest downtime, protect
your equipment by selecting the appropriate service contract.
 Process
Development
Services
Continued
Platform
Service and
Processes
Support
Integrated
Solutions
Single-use Process
FlexAct® & Cost
Technology Modelling

Process Design
and Engineering

These Clients are Successful with Integrated Solutions:

 Americas Asia |Pacific
USA Australia
Sartorius Stedim North America Inc. Sartorius Stedim Australia Pty. Ltd.
5 Orville Drive, Suite 200 Unit 5, 7-11 Rodeo Drive
Bohemia, NY 11716 Dandenong South Vic 3175

Specifications subject to change without notice. Copyright Sartorius Stedim Biotech GmbH. Printed in the EU on paper bleached without chlorine.
Toll-Free +1.800.368.7178 Phone +61.3.8762.1800

Argentina China
Sartorius Argentina S.A. Sartorius Stedim Biotech (Beijing) Co. Ltd.
Int. A. Ávalos 4251 No. 33 Yu’an Road
B1605ECS Munro Airport Industrial Park Zone B
m.com Buenos Aires Shunyi District, Beijing 101300
Phone +54.11.4721.0505 Phone +86.10.80426516

Brazil Sartorius Stedim (Shanghai)

Sartorius do Brasil Ltda
Avenida Senador Vergueiro 2962
Contact Us:
São Bernardo do Campo
CEP 09600-000 - SP- Brasil
To find out how our
Integrated
Phone +55.11.4362.8900
capacity expansion projects please request more information at the following link:
Mexico
Sartorius de México, S.A. de C.V.
www.sartorius.com/sartorius/en/EUR/integrated-solutions/contact-us
Libramiento Norte de Tepotzotlan s/n,
Colonia Barrio Tlacateco,
Sales and Service Contacts
Municipio de Tepotzotlan,
Estado de México,
For
C.P. 54605 further contacts, visit www.sartorius-stedim.com
Phone +52.55.5562.1102
Europe
leadsmex@sartorius.com
Germany
Peru
Sartorius Stedim Biotech GmbH
Sartorius Peru S.A.C.
August-Spindler-Strasse 11
Avenue Alberto del Campo 411
37079 Goettingen
Floor 12 – The Office
15076 Phone +49.551.308.0
– San Isidro, Lima
Phone +51.1.441 0158
Sartorius Stedim Systems GmbH
Robert-Bosch-Strasse 5 – 7
34302 Guxhagen
Phone +49.5665.407.0
France
Sartorius Stedim FMT S.A.S.
ZI des Paluds
Avenue de Jouques – CS 91051
13781 Aubagne Cedex
Trading Co., Ltd.
3rd Floor, North Wing, Tower 1
No. 4560 Jinke Road
Zhangjiang Hi-Tech Park
Pudong
Districtteam can help
Solutions with your single-use or hybrid
Shanghai 201210, P.R. China
Phone +86.21.6878.2300
Publication No.: S--1553-e171001 · Order No.: 85037-560-39 · Ver. 10 | 2017
Sartorius Stedim Biotech (Beijing) Co. Ltd.
Guangzhou Representative Office
Unit K, Building 23
Huihua Commerce & Trade Building
No. 80 Xianlie Middle Road
Guangzhou 510070
Phone +86.20.37618687 | 37618651
Americas Asia | Pacific
India Italy USA Australia
Sartorius
Sartorius StedimStedim Italy
India Pvt. S.r.l.
Ltd. Sartorius Stedim North America Inc. Sartorius Stedim Australia Pty. Ltd.
Via dell’Antella, 76/A
#69/2-69/3, NH 48, Jakkasandra 5 Orville Drive, Suite 200 Unit 5, 7-11 Rodeo Drive
50012 Tq
Antella-Bagno a Ripoli (FI)
Nelamangala Bohemia, NY 11716 Dandenong South Vic 3175
562 123 Bangalore,
Phone India
+39.055.63.40.41
Toll-Free +1.800.368.7178 Phone +61.3.8762.1800
Phone +91.80.4350.5250
Netherlands Argentina China
Japan Sartorius Stedim Netherlands B.V. Sartorius Argentina S.A. Sartorius Stedim Biotech (Beijing) Co. Ltd.
Sartorius Stedim
Phone Japan K.K.
+31.30.60.25.080 Int. A. Ávalos 4251 No. 33 Yu’an Road
4th Fl., Daiwa Shinagawa North Bldg. B1605ECS Munro Airport Industrial Park Zone B
filtratie.nederland@sartorius-stedim.com
8-11, Kita-Shinagawa 1-chome Buenos Aires Shunyi District, Beijing 101300
Shinagawa-ku, Tokyo, 140-0001 Japan
Phone +54.11.4721.0505 Phone +86.10.80426516
Phone Poland
+81.3.4331.4300
Sartorius Stedim Poland Sp. z o.o.
ul. Wrzesinska 70 Brazil Sartorius Stedim (Shanghai)
Malaysia
62-025 Kostrzyn Sartorius do Brasil Ltda Trading Co., Ltd.
Sartorius Stedim Malaysia Sdn. Bhd. Avenida Senador Vergueiro 2962 3rd Floor, North Wing, Tower 1