Insight
Sartorius in Profile

Foreword

Dear Readers,
Many serious diseases, such as cancer, rheumatism and Alzheimer’s, are still incurable ortreatable only to a limited extent. Although
global medical knowledge has doubled withinjust a few years, the development of new drugs
has become increasingly time-consuming andcostly.
Successes in the fight against certain cancers
and autoimmune diseases have been achieved
with biopharmaceutical drugs, which have
evolved from a medical novelty into a dependable
therapeutic within a few decades. In the fieldof gene and cell therapy, recent breakthroughs
promise further progress.

The prerequisite for these successes is thatscientists and engineers are given the right tools
and technologies to speed up the developmentof drugs and simplify production. This is where
Sartorius comes in. Our brand promise puts thisin a nutshell: Simplifying Progress. We help totranslate new scientific discoveries into better
patient care faster and give more people accessto better medicine. You can find out how we dothis, what motivates us and what our goals are on
the following pages.

Dr. Joachim Kreuzburg
Chairman of the Board

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3

Contents

8

Biopharmaceuticals in Focus

10

Innovative Solutions for Better Medications

16

People at Sartorius

20

Did You Know ...?

22

Faster Drug Development

30

Efficiency in Drug Production

40

Everything From a Single Source: Our Products

42

Strong Company Values

44

Well Combined for Innovation

46

At Home Worldwide

48

Innovation for More Than 150 Years

Find our latest key figuresand further information.

5

Mission
At Sartorius, we empower scientists and engineers to simplify
and accelerate progress in life sciences and bioprocessing,enabling the development of new and better therapies andmore affordable medicine.

VisionWe are a magnet and dynamic platform for pioneers andleading experts in our field. We bring creative minds together
for a common goal: technological breakthroughs that lead tobetter health for more people.

Insight

Biopharmaceuticals
in Focus

Bioprocess Solutions
Sartorius offers customers in biopharmaceutical production abroad product portfolio that covers all the steps in the manufacturing of a biopharmaceutical. In this way, the company
helps ensure that biotech drugs and vaccines can be produced
safely and efficiently. Sartorius is one of the leading manufacturers in filtration, fermentation, membrane chromatography
and fluid management.

With its two divisions, Bioprocess Solutions and Lab Products & Services,
Sartorius focuses on the biopharmaceutical industry. Offering solutions
covering the entire biopharmaceutical value chain, the company supports
its customers in increasing efficiency in drug development and simplifying
production.
Cell cultivation, media andcell culture components

Fluid Management

Filtration

Purification

Bioprocess Solutions Division
Molecule Development

Cell Line and Process

Development

Upstream and Downstream Production

Quality Control and Testing

Lab Products & Services Division

Lab instruments and consumables

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Bioanalytical instruments

Lab Products & Services
Sartorius aims to simplify the complex and expensive
develop­ment process for biopharmaceuticals and to speed
up scientific advancement. To this end, the company provides innovative solutions for bioanalytics and premium lab
products, consumables and services to laboratories in thepharmaceutical and biopharmaceutical industries, as well as
academic research facilities. Sartorius is a market leader forlaboratory balances, pipettes, and lab consumables.

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Innovative
Solutions for
Better Medications
With its expert knowledge, ingenuity andunderstanding of customer needs, Sartorius
has developed into a key partner of life science
research and the biopharmaceutical industry
in its more than 150-year history. Today, ouremployees worldwide are committed to ensuringthat new medications can be developed fasterand produced more efficiently, using Sartorius‘
innovative tools and technologies.

The Ambr® 15 Microbioreactor Vessel
determines optimal production conditions and is therefore an important tool
for process development.

10Insight
What are
Biopharmaceuticals?
Traditional chemically manufactured drugs are based on
small molecules of only a few
atoms. The situation is different
with biopharmaceutical active
ingredients. They are produced
using living organisms — such asbacteria, yeasts or mammaliancells — and consist of very large
molecules with up to 20,000
atoms. Therefore, they cannot
be administered as tablets,
but by injection or infusion.
The advantages: biopharmaceuticals only bind to very
specific cell receptors andthereby intervene in the body‘s
own processes in a more targeted manner than other drugs.
They open up new therapeutic
options for patients with severeor rare diseases and are particularly promising candidates in thefight against cancer.

Biopharmaceutical agent

Sterile bags for cell culture processes

Whether cancer, dementia,
diabetes, or rheumatism: many
serious diseases are still incurable or can be treated only to alimited extent. To combat these
diseases, biopharmaceuticals
that are produced with the helpof living organisms in complex
research and production processes are playing an increasingly important role. Since the1980s when the first biopharmaceutical, human insulin, waslaunched onto the market, theindustry has been evolving at an
exceptionally fast pace.
In 2020, six of the ten bestselling drugs worldwide were
biologics; in the same year,
biotechnologically produced
active ingredients accounted
for approximately one third of
new drug approvals in the USA.
Sartorius has contributed tothis progress. With innovative
tools and technologies that
ensure more efficient processes

at every stage from research to
production, Sartorius is helping
to ensure that more people haveaccess to affordable medicine.
Technologies for Every Phaseof the Value Chain
Sartorius identified the potentialof the biopharma sector at an
early stage and subsequentlyaligned its product and service
portfolio to this industry’s
requirements. Founded as aprecision mechanical workshop for analytical balances in
1870, today’s Sartorius Group is
positioned as a strategic partner
for life science research and thebiopharmaceutical industry.
The Sartorius Group supports
its customers every step of
the way from the initial idea tothe market readiness of a new
medication — a long, labor-intensive and expensive journey.
On average, only one in 10,000
drug candidates actually makes
it to the pharmacy counter.

Share of biopharmaceuticals in the
top ten best-selling drugs

1 out of 10 | 2000

6 out of 10 | 2020

and the storage and transfer of fluids
are a safe, less expensive alternative
to glass or stainless steel. Sartorius isone of the world’s leading technology
providers in this field.

Getting to this stage often takes
more than a decade, with total
costs of over two billion euros
being the rule. Biopharmaceuticals are much more expensive
to produce than drugs that are
manufactured using chemical
processes. This, in turn, puts
mounting pressure on healthcare systems — and, thus, also
on the pharma sector, whichfaces the challenge of designingits workflows and manufacturing operations as efficiently
as possible. With its solutions
available throughout the entire
biopharmaceutical industry’svalue chain, Sartorius empowers
its customers to accelerate drug
discovery and development andsimplify production. Premium
laboratory instruments simplify
meticulous and routine laboratory work and deliver reproducible results; innovative
bioanalytical systems accelerate

the identification of suitable
drug candidates; highly
automated microbioreactors help to determine theoptimal growth conditions
for cell cultures in parallel
experimental series; and abroad portfolio of scalable
single-use products, such asbioreactors, filters and bags,
is available for the actual
manufacture and purificationof pharmaceuticals. Compared with stainless steel systems, these single-use solutions have many advantages,
particularly for production
batches of up to 2,000 L.
With a much lower capitaloutlay, they are faster toinstall, can be readily adapted to accommodate new
production processes andare even more environmentally friendly than stainlesssteel systems, as single-use
products eliminate the needfor labor-intensive and expensive cleaning procedures after
every production run. At thesame time, single-use systems
minimize the risk of contamination by bacteria, fungi andviruses, which can sometimes
survive even the most thoroughcleaning protocols.
Focus on Customer Benefits
The growth of the Group showsthat Sartorius meets the qualitatively and quantitatively increasing needs of a demanding
customer group. In recent years,
Sartorius has increased its sales
revenue by a significant double-digit percentage per year
on average. In many productcategories, the Group is among
the global market leaders. The
company plans to continue togrow strongly.

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Insight
In addition to organic growth,
especially in the Asian andAmerican markets, acquisitions
are expected to support the positive development. The primaryobjective of these acquisitions
is to further increase customer
benefits by expanding the
product portfolio in a meaningful way. In this way, Sartorius iscontinuously strengthening its
business with complementaryacquisitions of technologies
that can help the biopharmaceutical industry and researchto achieve greater efficiency
gains. With this strategy, overthe last years, the company has
acquired solutions for digitalization and automation, innovative
processes in bioanalytics, andtrailblazing technologies fornovel treatments, including the
takeover of selected life sciencebusinesses of the U.S. Danahergroup, and the purification specialist BIA Separations that focuses on gene and cell therapies.

Application Knowledge
as a Success Factor
To achieve success in a
dynamically growing andhighly complex environment,
Sartorius needs one thing
above all: employees whostay at the forefront of therapid developments in thebiopharmaceutical industry
and who are able to implement the requirements andwishes of the customers
in the best possible way.
To better understand thechallenges of the industry
and to continuously expand
its application know-how,Sartorius places greatemphasis on close exchangewith customers and relevantscientific institutions. Intensive cooperation agreementswith the German ResearchInstitute for Artificial Intelligence (DFKI), as well as
Penn State University and
the National Institute forInnovation in Manufacturing
Biopharmaceuticals (NIIMBL)
in the U.S. have a very clear
objective: to promote scientificadvances in drug development
and, in the long term, to reducethe costs of biopharmaceuticalproduction so that more people
can have access to better treatments.

Sartorius generates a large portion of
its revenue from membrane-based
products. The filtration portfolio isamong the most comprehensive in
the industry.

Sartorius has its roots in weighing
technology. The Cubis® II
optimizes weighing results fromexperiments and test series inlaboratories.

Sartorius continuously
expands its product portfolio through acquisitionsof cost- and time-saving
innovations in thebiopharmaceutical andlife science fields.

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People at Sartorius

In Bangalore, India, Sartorius employees
produce stainless steel bioreactors, components, and filters.

Sartorius unites ambitious people: They are life science enthusiasts, doers, risk takers, creativeminds, and, above all, partners for our customers. They all share one ambition: translating
scientific discoveries into medicine faster and more efficiently. As a listed company with global
activities, Sartorius has retained the mindset that made it a pioneer in its industry as a startup
more than 150 years ago: customer focus, can-do attitude, hands-on approach, and eachindividual’s ambition to contribute.

Be Part of the Solution
Our customers are facing major challenges.
Numerous diseases are still incurable; many are
untreatable. New medications need to be developed and be made available worldwide. With its
innovative technologies, Sartorius is part of thesolution. For our employees, this purpose is bothan opportunity and a commitment. To provide
our customers with the right tools and achieve
pioneering technological breakthroughs, weneed technical expertise and customer knowledge as well as a strong sense of ambition and,quite often, a high level of persistence.
Grow With Us
Sartorius is one of the fastest-growing global
players in its industry. We create and take
opportunities, constantly integrating new technologies through acquisitions and partnerships.
As a leading partner of life science research andthe biopharmaceutical industry, we focus on
dynamic sectors and highly innovative markets
that will continue to grow for decades.

Find information about thediversity at Sartorius here

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This opens up a world of options for those whohave the drive to pursue them. We entrust ourpeople with responsibility and, in return, expect
them to have the courage to take risks and makebold decisions to move forward. Depending on
personal goals and changing priorities in life,
they can grow their careers in diverse ways —from technical to geographical aspects.
Add the Missing View
Sartorius offers the perfect size and culture for
ambitious doers and diverse minds: every voice
is heard. Each new perspective has the potential to be the missing piece for the next gamechanging discovery. Yet we believe that major
challenges are best mastered together: whenexperienced specialists — many of them among
the best in their fields — fuse their expertise andperspectives. That is why we foster exchange
across fields, borders, cultures, and social backgrounds.

Thomas Kivela

Noushin Delmdahl

Sandra Mei

Expert for single-use technologies;

Protein biochemist; specializes

Specialist for Humandevelops biopharmaceuticalin filtration technologies for

Resources Management

processes for customers

laboratories

in Asia

Making a Fresh Start

United by Shared Goals

Growing With Your Tasks“I wanted a new start when
I joined Sartorius shortly
before the pandemic. After18 years in the biopharmaceutical industry, I had
learned a lot about cost- andtime-saving consumables.
However, I wanted to havemore freedom in the decision-making processes andto think more out of the box.
From people in my field,
I knew that Sartorius could
offer me this. During the firstweeks, I visited sites andcustomers, but then transitioned to working from homein March 2020. Thanks to
the open culture at Sartorius,
everyone is well connected.
From day one, my colleagues involved me in ongoingprojects. This allowed me tomake a contribution from thevery beginning. I have implemented various projects
within the first year. Things
couldn’t be better.”“Before I joined Sartorius in
2001, I had mostly worked on
scientific projects and spent
a lot of time in the lab. Afterswitching to the company,
I took on new team-basedand customer-facing tasks.
Today, I collaborate closelywith colleagues all over theworld and appreciate thedynamics that are generated
in a team when you work
towards achieving sharedgoals. I have experienced
over and over again thatborders and time zones playa minimal role when you
want to talk to a colleague or
ask someone for advice, forexample, in India. In addition,
because I’ve been able tofurther develop my skills andknowledge at Sartorius, theyears have flown by. Yet, with
our expansion into the fieldof bioanalytics, the scientist
in me knows that the most
exciting times are still tocome.”“’I can handle it’, is what I
thought when I was assigned
responsibility for five additional Asian countries. Before
that, I had spent three years
exclusively dedicating myefforts to taking care ofstaffing for the strongly
growing Chinese market.
My new set of tasks turned
out to be more complex than
I had originally expected:
the cultural differences
between the countries are
considerable, so handlingjob candidates requires a lotof tact, good instincts andskill. Since then, I have beenlearning something new
every day. What I especiallyenjoy about my job is the
freedom to define my work
schedule and activities.
As a result, I can fulfill mypersonal needs andcontinuously broaden myhorizons. I can’t think of abetter way to be motivatedthan working like this.”

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In Yauco, Puerto Rico, Sartorius
employees manufacture membranefilters and single-use bags for theAmerican market.

Did You Know That...?

… biotechnology can reduce ourdependence on drug sources?
The vast majority of flu vaccines are producedwith the help of serum eggs. About half a billionof these are needed each flu season. The production method has long lead times and is subject
to risk, such as not enough eggs being available
in the event of a pandemic. The World HealthOrganization (WHO) therefore advocates for adiversification of processes through, for example,
cell-based production.

… company founder Florenz Sartoriusalready successfully brooded over inventionsof which the basic ideas are still used today inbiopharmaceutical production?
Sartorius developed heating devices that wereused for bacteriological purposes and as incubators in poultry breeding. Thermostats regulated
the ambient temperature so precisely that thecultivation and incubation process could be
accurately controlled. The technology —a precursor of today’s bioreactors —sold successfully throughout Europe.

100
10

0.1

Eroom's Law

1950

2015

… single-use technology is more environmentally friendly than reusable products?
Single-use products, such as bags, filters andcentrifuges, eliminate the need for costly cleaning procedures. Therefore, during their use,
they have less of an ecological impact thanreusable product solutions — energy and water
consumption are more than 50 percent lower.
After use, the energy-rich single-use materials
are incinerated to generate energy. In this way,
Sartorius supports its customers in making
production processes greener and more efficient.

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With the Incucyte® S3, researchers can observe
living cells in real time directly in the incubator to
analyze how active pharmaceutical ingredients
attack and destroy cancer cells. Until now, it was
only possible to photograph cell cultures at certain
times and document the changes afterwards. The
Incucyte® S3 reduces the effort compared withthe manual method and provides better results
without disturbing sensitive cultures.

... the number of approved drugs per U.S. $1 billion
spent on R&D has halved roughly every nine years
since 1950?

Number of medications

1.0… Sartorius also supplies surveillance technologies?

As paradoxical as it may seem and despite
many technological and medical advances, thedevelopment of new drugs is becoming increasingly inefficient. This is why we speak of “Eroom’s
Law,” a reversal of the concept coined by Intelco-founder Gordon E. Moore in 1965, according
to which the performance of processors doubles
every two years. Sartorius is helping to reverse thistrend and shorten the time to results.

Energy costs… medication can be tailored to
an individual person?
In CAR-T cell therapy for the treatment ofcertain forms of leukemia, the body’s own
immune cells are removed, genetically modified,multiplied and returned to the patient. This
process is complex and expensive — and results
in a drug that can only be administered to one
person. Sartorius’ solutions speed up development and ensure reliable production.

Water costs… even serious scientific research sometimes
transcends earthly things?

-55%–65%

Stainlesssteel

Single- Stainless
use
steel

-65%–75%

SingleuseNASA used the Sartorius Air-Port MD8 airsampler on the International Space Station (ISS)to learn more about airborne microbial contamination and its possible effects on the crew. The
device filters up to 125 L of air per minute andcollects viruses, fungi and bacteria for subsequentcultivation and microbiological analysis.
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Faster to Market
Biopharmaceutical research and development canbe likened to looking for a needle in a haystack.
With groundbreaking analytical technologies
and premium laboratory instruments, Sartorius isproviding researchers with the tools that help toidentify new active drug compounds faster.

The Incucyte® enables complete
visual monitoring and analysis of cell
reactions and interactions directly in the
incubator without disturbing sensitive
cell cultures.

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Insight

Only One in 10,000 Drug Candidates
Reaches the Market

Discovery

Tests

Clinical trials

Approval

4 — 5 years

1 year4 — 7 years

1 — 2 years

Unusable patent protection

Patent application
0

1

2

3

4

5

6

7

8

9

>10

* Schematic visualization based on data from the Association of the British Pharmaceutical Industry

The rate of finding a successful candidate gives
even the uninitiated among us an idea of how
complex and laborious biopharmaceuticalresearch and development is: only one in
10,000 potential drug candidates makes it to
the market as a new treatment. Getting there isa long haul, involving thousands of experiments,
sample preparation procedures and analyses.
Therefore, one of the biggest challenges in24biopharmaceutical research and development
is to significantly shorten the drug discovery
timeline. This is all the more true because active
ingredients have to be patented early in the R&D
process. With a patent protection period of
20 years from the filing date, only about twelve
years of market exclusivity remain on averageafter final approval of the drug. Sartorius
technologies help to achieve results faster.

An expensive andtime-consuming path
Pharmaceutical companies invest more than twobillion euros to bring a new drug to market. In manycases, development takes more than ten years.
Technologies from Sartorius speed up the research
process and reduce costs.

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Insight

Microsart® Kits enable thedetection of mycoplasmas
in just a few hours andare used in every process
phase of biopharmaceuticalresearch and production.

The comprehensive functionsof Sartorius laboratory balances
simplify complex applications
and guarantee compliance withthe required standards.

Octet® systems allow scientists to analyze molecularinteraction in real time without the need for markers.

The Turbo in Biopharma Research
In the search for new therapies, researchers
must first find a gateway to combat the disease,such as a specific type of cancer. Unlike
chemotherapy or radiotherapy, biopharmaceuticals often use a patient’s own immune
system. For instance, monoclonal antibodies(mAbs) are of great importance in this therapeutic approach. These proteins, produced byliving organisms and developed in the lab, aredesigned so that they specifically bind to sites
on cancer cells, marking them for destruction
by the immune system. What sounds simple intheory is, in fact, a long and painstaking process
in the laboratory.

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Sartorius offers innovative bioanalytical systems
to simplify and accelerate the selection of drugcandidates. For example, Incucyte® and iQue®
Screener deliver answers to essential questions,such as: Is the cell alive? Is it dividing? Is it producing the desired antibody? How does my active
pharmaceutical ingredient interact with diseasedor healthy cells? While Incucyte® enables thecontinuous visual monitoring and analysis of cell
reactions and interactions directly inside an
incubator with its live-cell imaging, the advantages of the fully automated iQue® Screener
platform lie in the combination of data depth
and high speed.

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A simultaneous feed of up to 1,536 samples,
analysis, data evaluation and even cleaning of
the instrument are performed without further
assistance from the laboratory staff. The smallest
sample volumes of only one microliter are
sufficient to obtain meaningful and multi-layered data on a wide range of cell parameters.
As a result, iQue® Screener not only accelerates
analysis tenfold, but also protects valuable cell
cultures and reduces the use of expensive reagents.
A key challenge in drug development is theability to identify molecules that bind to biomolecular structures on the surface of cells or
pathogens. To avoid undesired effects, researchers must seamlessly analyze and understandthese bonding events. Do molecules bond atall? How strong is their binding interaction andhow long does it last? With the Octet® platform
acquired from Danaher in 2020, Sartorius has
added a key technology for accelerated analysis of molecular interactions to its portfolio. It isbased on the patented biolayer interferometry
technology and enables label-free, real-time
analysis of biomolecular interactions.

Better Results, Less Effort
Manual and therefore time-consuming anderror-prone processes still characterize everyday laboratory work today. Here too, Sartorius
products ensure that better results can beobtained reproducibly, faster and safer. Premium
laboratory instruments, such as high-precisionbalances with intelligent assistance systems,
ergonomic pipettes to minimize muscle andjoint strain, and ultrapure water systems reducemanual effort and set the foundation for reliablesample preparation and analyses. For microbiological quality control, Sartorius offers a widearray of products, such as filtration systems,
sterility testing units and solutions for airborne
microbe sampling, virus quantification and forthe detection of mycoplasmas. They are used
not only for pharmaceutical research, but also
in the quality control laboratories of the foodand beverage industry, to test clinical products
and for monitoring both water and wastewater.
Yet, regardless of where our products are used,
they consistently help to prevent errors, simplify
workflows and reduce physical workloads.

The fluorescence-based iQue®
Screener platform rapidly examines
many thousands of samples in a shorttime and provides multivariate analysis
of cells and proteins in suspension.

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Efficiency in
Drug Production
In biopharmaceutical production, a combinationof the most diverse factors is decisive for the quality
and cost-effectiveness of the final drug. It’s nocoincidence that experts claim that “the process isthe product.” With scalable single-use technologies
for bioreactors, filters and bags, as well as tools forprocess development and monitoring, Sartorius
helps its customers to obtain the best possible
results from their manufacturing processes,
in terms of both quality and quantity.

Single-use technologies offer a safeand flexible alternative to conventional containers made of stainlesssteel or glass.

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Insight

The fully preassembled UniVessel®
single-use bioreactor for volumes of
up to 2 L reduces the time and effort
required to develop, optimize andvalidate cell culture processes.

Sartobind® membrane­chromato­graphy systems weredeveloped to purify biomolecules.
They are used to remove impurities, such as DNA, endotoxins,
host cell proteins and viruses,
quickly and reliably.

With the automated microbioreactor system Ambr® 15, researchers canconduct up to 48 independent cell culture experiments in a very small space.

The cell line used, the composition of the cell
culture medium, oxygen and pH, temperature,stirring speed: the list of factors governing the
success or failure of a biopharmaceuticalproduction process is long. Why? Cells aredemanding and require optimal conditions
to grow and produce the desired drug in thelargest possible quantity. Sartorius, with its
broad-based portfolio of products, covers nearly
every stage of biopharmaceutical manufacturing — from cell line development, cultivationand multiplication of cells, to cell harvesting andpurification, to filling of the final product.

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High-Tech Solutions That Fit in a Shot Glass
To ensure successful commercial-scale manufacturing, a production process is initially tested
at a much smaller scale. Similar to the researchphase, digitalization and automation solutions
from Sartorius also help to achieve higherquality results in less time during processdevelopment. The Ambr® is an automatedbioreactor platform with vessel sizes of 15 mL or
250 mL, which can be used to perform up to
48 experiments simultaneously in a very small
space. For each of these miniature bioreactors,
the individual parameters, such as nutrient
composition or pH, are set individually.

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Insight

Sartoclear® depth filters weredeveloped for demanding clarification applications in the biotechnological and pharmaceuticalindustries. The modular devices
provide linear scalability fromsmall to large scale processes.

The preassembled Maxicaps®
MR single-use filter configuration
for the filtration of large volumes
requires 90% fewer hoses andconnections than comparable
stainless steel systems.
Multivariate software for modeling and monitoring cell culture
processes helps to improve product quality and increase drug yield.

The system regularly takes samples to monitor
and document cell development, autonomously
maintaining stable cell cultivation conditions.
Once the ideal interaction between parameters
has been established, it is important to be able
to reproduce the same conditions independentlyof the size of a bioreactor. Sartorius technologies
enable processes to be scaled from 250 mL to
2,000 L. But this isn’t their only advantage.
For many of the industry‘s challenges, such as
time and cost pressures, hygienic and regulatory
requirements, and the trend toward smaller
production batches, they are a flexible, safe
and cost-effective alternative. Compared withstainless steel systems, the initial investment insingle-use equipment is much lower, the timeneeded for planning and commissioning is less,single-use systems are easier to change over to34

manufacture other products, and the risk of contamination by bacteria, fungi or viruses is considerably reduced. This is achieved because after
each production run, any part that comes into
contact with the liquid cell broth is replaced bycompletely new, sterile-packaged components.
The procedures required to clean stainless steel
systems using chemicals and steam sterilization
are eliminated entirely. This is not only more environmentally friendly, but also reduces the timeneeded to prepare the system for the next production process to just a few hours. Therefore,
it’s no surprise that single-use technologies arebeing increasingly used in biopharmaceuticalresearch and production, especially for relatively
small drug batches. Sartorius, with its broad andinnovative array of products, is actively contributing to this trend and is the leading global
provider of single-use bioreactors and bags.

Precise Control of Sensitive Processes
What succeeds during cell culture cultivationand subsequent volume expansion should not
malfunction during the actual production in the
2,000 L bioreactor. As cell cultures are highly
sensitive and react to the slightest changes,
strict monitoring of the production process isvital. In this phase, Sartorius uses process
measurement technology and software formultivariate data analysis to ensure that relevant
parameter measurements can be collected,
documented and evaluated in real time. The
system reveals correlation patterns between theindividual parameters so that the right conclusions can be drawn and countermeasures taken
in good time in the event of process deviations.
This ensures that each batch meets the highest
quality requirements and reduces the risk oflosing a complete production batch.

Purification Expertise From the Source
Once the cells have produced the desired
amount of antibodies, the complex downstream
process begins, in which the active ingredient isgradually separated from impurities and unwanted components of the cell broth. Membranes
and chromatography systems play an importantrole in this process. Sartorius’ extensive filtration
portfolio is based on about a century of experience: back in 1927 Sartorius, together with Richard
Zsigmondy, the Nobel Prize winner for chemistry,developed a method for the industrial productionof the synthetic membrane filters that Zsigmondy
had invented. More recently, the company has
expanded its purification expertise considerably with the acquisitions of the chromatography
portfolios of U.S.-based Danaher and French
company Novasep — the aim is to offer customers
individual and flexible solutions for expensive
downstream processing.

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Celsius® Pak enables consistent, reproducible freezing
and thawing of biopharmaceutical liquids and is suitable
for long-term frozen storage.

Every production process isdifferent. Sartorius, in collaboration with its customers,
develops and implements
individual solutions from thedevelopment phase throughto industrial production.

Sartorius is now one of the leaders in the global
market for filtration solutions and has one of
the most extensive purification portfolios in
the industry.
However, Sartorius is not, and never will be,content to rest on the laurels of its past successes. With a great understanding of its customers’
needs, the company works continuously on improving its solutions and expanding them acrossthe entire biopharmaceutical value chain. For in­
stance, since the acquisition of BIA Separationsin 2020, Sartorius also has technologies forcomplex purification of gene and cell therapies. The corporate objective is clearly defined:
Sartorius aims to use its innovations to accelerate research, simplify production and contributetoward giving more people access to bettermedicines.
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Worldwide Expenditure on Biopharmaceuticals
in billions of U.S. $
2026*
2022
2018

228

366

521

* Forecast; Source: Evaluate Pharma, World Preview 2021
Outlook to 2026, July 2021

Upstream, Sartorius is the world leader with its extensive range of bioreactors in different sizes. Downstream, Sartorius
drives technological progress by developing new or improved single-use technologies in the areas of chromatography andfreeze & thaw systems.

Insight

Everything From a Single Source
Today, monoclonal antibodies represent one of the most successful strategies in the fight against
various cancers. They are developed and produced using living, genetically modified mammaliancells in sophisticated processes. Sartorius’ innovative solutions are used in nearly all steps ofbiopharmaceutical research and manufacturing — from molecule and cell line development tocell growth, to purification and filling of the final product.

Incucyte® real-time analysis

iQue® Screener Plus

Octet® systems for marker-free

Ambr® 15 fully automatedMycap® aseptic fluid

Fill-It automated high-system for living cells

high-throughput screening

analysis of molecular interactions

microbioreactor systemtransfer system for bottles

throughput filling system

Minisart® syringe filters

Cubis® high-performance

Picus® NxT multichannel

Arium® ultrapure lab water system

Sartoclear® Dynamics Lab for clarification

Microsart® mycoplasma kit

laboratory balance

electronic pipetteand sterile filtration of cell cultures

for rapid mycoplasma detection

Molecule Development

Fill-It

Cell Line and Process Development

Identification of
Target Molecules

Library
Screening

Optimization andCharacterization of Candidates

Gene Cloning
and Transfection

Cell Line Selection and
Identification

Cell Line Characterization
and Cell Banking

Drug development begins withthe search for a therapeutic target.
The focus is on the question ofwhich signaling pathways thedisease is based on and whatrole the target plays in this. The
Incucyte® cell analysis platform
allows end-to-end monitoring ofliving cells directly in the incubator and provides detailed insights
into the biological mechanisms inreal time.

Screening identifies the mostpromising antibodies. To dothis, antibody libraries, containing millions of different
candidates, are used. On
average, around 1,000 ofthem are shortlisted. The
iQue® Screener high-­
throughput flow cytometer
helps to analyze cells andtheir products. It combines
speed with great data depth
and can quickly identify andcharacterize drug candidates.
With a combination of data
depth and high speed, it iscapable of quickly identifying
and screening drug candidates.

The antibody candidates areanalyzed in more depth andoptimized. The Octet® systems
are based on biolayer interferometry and provide important
information about the bonding
capabilities of the molecules.
One advantage of this label-freemethod is that no dyes are required. As a result, the sample being
investigated remains unaltered.
The next step involves analyses toprovide a complete description of
the antibody. This includes its
efficacy and toxicologicalproperties. The aim is also to
discover whether changes to themolecule could have an adverse
effect on patient safety.

A stable cell line that reliably
produces the antibody inlarge quantities is required forthe production of the active
compound. A DNA sequencethat is cloned millions of times
with the help of bacteria andserves as a construction manual for the protein is inserted
into the DNA of the host cells.
However, this process, known
as transfection, succeeds inonly some of the cells. The
respective cell populations
are selected and cultivatedusing a special procedure.

The cells from the most promising cultures are isolated for further propagation. This creates the
monoclonal populations requiredfor industrial production. Performance is assessed using parameters such as cell growth, productivity, viability, and the quality ofthe mAbs produced. The search
for the optimum clones is accelerated by the fully automatedAmbr® 15 microbioreactor systemsystem, which performs up to
48 experiments simultaneously.

Prerequisites for the further use
of cell lines are their completecharacterization and the creationof a master cell bank. For thispurpose, clones of a single cell
culture are deep frozen for later
use. This allows each production
process to be started with “fresh”
cells. Sartorius supports thecomplete process from cloning
the DNA sequence to creating
the cell bank.

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Insight

Media | Storage and mixing bags | Virus filter cartridges

Bioreactors | Sensors for process analysis

Depth filters | Centrifuges

Sterile filters | Tangential flow filtration systems (ultrafiltration)

Mixing tanks | Virus filter cartridges

Chromatography (membrane and gels)

Tangential flow filtration systems | Diafiltration |Freeze and thaw systems | Filling systems

Sterile filters

Upstream

Downstream

Cell Culture Media Production & Cultivation

Scale-Up and Production

Separation and Centrifugation

Filtration

Viral Clearance

Polishing | Capture

Concentration and Sterile Filtration

Deep-Freeze Storage and Final Filling

For optimal division of the cells, they need
perfect conditions. The culture medium— adapted to the respective cell culture— plays a critical role. It contains nutrients,
such as proteins and sugars, and provides
the cells with everything they need to thrive.

To produce large quantities of antibodies, thecells are transferred step by step to ever-larger
bioreactors. There, they grow only when theconditions are ideal; influencing factors here
include oxygen content, pH and temperature.
During this phase, the cells begin to release
the required antibodies into the cell culture
medium. To prevent contamination withbacteria or viruses, production takes place
under sterile conditions.

The cells are harvested at the end of a
production run. The multivariate analysis
software Simca®, which can be used to modeland predict production processes, helps todetermine the optimal time for this. During cell
harvesting, the antibodies in the suspension are
freed of cells and cell fragments — for example,
by filtration or centrifugation.

Viruses that may be present in the liquid areremoved and inactivated by virus removal filters,
adsorption or by lowering the pH. Manufacturers must use at least three different methods
for a drug to be approved. The different viralclearance processes must be able to remove a
specific total amount. Sartorius’ portfolio contains products to cover all of these virus removal
methods.

HCP(host cell proteins)

Polishing removes any remaining contamination,such as DNA or host cell proteins. Unlike filtration,
which uses membranes to filter according toparticle size, polishing is a chromatographic
purification process. In this step, properties suchas charge, hydrophobicity or the binding affinityof the proteins are used to purify the target molecule. MAbs are primarily purified using protein
A affinity chromatography and then rinsed out
for the next process step using buffer solutions(capture). Sartorius’ product range includes resines, chromatography membranes and monoliths, as well as stainless steel and single-use
systems in the hardware sector.

As with all biopharmaceuticals, antibodies
used in cancer therapy are too fragile to passthrough gastric acid without being damaged.
To obtain an injectable drug, the antibody
solution is calibrated to the final concentration,
its pH is adjusted, and the necessary excipientsare added. Before filling, the product once
again undergoes sterile filtration.

Cell propagation

After the harvest, the antibodies are purified
to isolate them from other components of thesolution. A combination of chromatography andTangential Flow Filtration (TFF) is used to achieve
the desired purity. In TFF, the liquid is pumped
across a membrane and pulled out across the
direction of flow to remove water, salts and small
proteins. Sartorius has one of the most extensive
TFF portfolios in the industry. The fully automated,closed-loop single-use systems not only ensure
more flexibility in production, they also reduce
the risk of contamination by viruses and bacteria.

Sartorius has developed innovative freeze &thaw systems so that manufacturers do nothave to fill the drugs into their final containers
immediately after production. With these systems, intermediates and ready-to-use drugs
can be frozen, stored and transported quickly
and evenly in sterile bags and then be thawedout again later. This allows manufacturers to
produce and stockpile large quantities of anactive ingredient to respond flexibly to changes
in demand.

Cell culture
mediumHost cell

Cell fragments

Antibodies

DNA

Inactive virus
Antibodies
Active virus

Antibodies
Active virus

Antibodyof interest

Host cell protein
Polishing

CaptureIn the final production step, the drug issterilely filled into syringes or ampoules.

Insight

Strong Company Values
Sustainability, openness and enjoyment are the values that shape our workwith colleagues, customers and business partners alike. By incorporatingthem into our thinking and actions on a daily basis, we create a positive
corporate culture, which is an important source of long-term economic
success, lasting motivation and above-average performance.

Sustainability
Growing profitably and acting responsibly towards all stakeholders
For Sartorius, sustainability means working towards positive and all-aroundsuccessful relationships with various stakeholders in all business activities.
Customer orientation, excellence and innovation form the basis for this.
We rely on lasting relationships based on trust with our customers andbusiness partners, enabling both sides to benefit. We offer our employees
a working environment in which they can continuously develop, bothprofessionally and personally. Investors can expect a corporate policythat is geared to continuous and sustainable value enhancement. We arecommitted to being a responsible member of society and a good neighborat our sites around the world.

Openness
A source of change and progress
It’s well known that “the better is the enemy of the good.” We regard
openness — both internally and externally — as a basic prerequisite forleveraging our great Group-wide potential, for questioning the tried and true,and for recognizing the better in the new. Combined with our technologicalknow-how, openness is key to developing innovations that really make adifference and create value for our customers.

Enjoyment
A working environment with freedom and appreciation
At Sartorius, hard work and pleasure go hand in hand because our employees not only work with their minds, but also with their hearts. In return,Sartorius offers them plenty of freedom and tasks that allow them to growand realize their personal potential. The company appeals to people who
like working in international teams, who enjoy taking on responsibility andwho appreciate breaking new ground and celebrating their success together. This team-oriented and open manner is also how we work together
with our customers.

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Insight

Intelligently Combined
The pressure to innovate in (bio)pharmaceutical researchand production is intense. For Sartorius, this means improving existing solutions in a user-oriented way, quickly
recognizing the potential of new technologies, forging
partnerships and transforming technologies into groundbreaking innovations through intelligent integration. The
Biostat STR® bioreactor family is the result of successfully
integrating proprietary core technologies, acquisitions andthe products of strategic partners.

Aseptic bags | With the acquisition of Stedim Biosystems,
the “inventor” of bags for biopharmaceutical applications,
Sartorius paved the way in 2007 for the development offully scalable single-use bioreactors with properties thatmatched those of traditional stainless steel stirred vessels.
The sterile, three-dimensional bags form the core of the reactor and are disposed of after production, including all tubes.

Bioreactor technology | In 2000, Sartorius acquired
B. Braun Biotech, the world’s leading provider offermentation technology, to expand its portfolio toinclude the central process step in biopharmaceuticalproduction. Although customers with large-volume
applications continue to rely on stainless steel
equipment from Sartorius, the trend for smaller
product batches is driving the use of flexible andcost-effective single-use solutions. The reusable bagholder, which does not come into contact with thecell culture, carries the temperature control system,
the drive motor for the stirrer and the filter holder.

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Filter technology | Filtration has been one of
the core technologies of Sartorius for about acentury. In addition to product quality, simple use
is also important for reliable filtration processes.
With presterilized filters in capsules or preassembled units with hoses and connectors, Sartorius
reduces the risk of user error and contamination.

Control and analysis software | The continuous
monitoring and control of critical parameters are
crucial for bioprocess efficiency and the qualityof the end product. In cooperation with Siemens,
Sartorius developed the cross-product automation
platform Biobrain® that makes it easier for customers to integrate their systems into higher-levelautomation solutions.
The multivariate data analysis software by Umetrics,
a company acquired in 2017, enables customers tomodel and optimize biopharmaceutical development and production processes. The real-time
analysis of production data provides deep insights
into an ongoing process and ensures consistently
high product quality.

Sensors | The sensors of our collaboration partners
continuously provide precise information about
critical process parameters — such as pH, oxygen
content, temperature, glucose, lactate value, living
biomass — without having to interfere with thesensitive cell culture process.

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Insight

At HomeWorldwide
Customer proximity begins with short distances. As a global
player, Sartorius is represented in more than 110 countries
with its own production facilities, sales offices, and local
commercial agencies.

Bohemia, USA

Göttingen, Germany

Kajaani, Finnland

Customers benefit from this geographical presence throughshort delivery times, fast order processing and personal
service. In turn, Sartorius uses its many years of close contact
with its customers to gain a precise understanding of theirprocesses and requirements.
Sartorius concentrates its business activities on the threecore markets of Europe, North America and Asia, with themost closely knit network being located in Europe due to thecompany’s history. Since the company’s foundation in 1870,
the university city of Göttingen in Lower Saxony has been theheadquarters and the largest manufacturing and development location. This is where Sartorius develops and produces
two of its core technologies: membrane filters and laboratory
instruments. Bags and tubing are manufactured at the plantin Aubagne, France. Sartorius serves North America, theworld‘s largest pharmaceutical and laboratory market as wellas the headquarters of many major customers and the sourceof numerous innovations, through its sales and distribution
center in Bohemia, New York. The most important production
facility in the region is the plant in Yauco, Puerto Rico.
Sartorius supplies its American biopharmaceutical customers
with membrane filters and sterile bags from this site.
Sartorius is active in the dynamically growing Asian market
from its sales headquarters in Shanghai, China. Beijing andBangalore are important production sites, where Sartorius
manufactures stainless steel bioreactors, single-use bags
and laboratory balances, among other products. To further
expand its foothold in the region, Sartorius is building a newplant for cell culture media and selected single-use productsin the biopharma hub of Songdo in South Korea.

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Beijing, China

Shanghai, China

Yauco, Puerto Rico

Find a current list of the Sartorius
locations worldwide here

Aubagne, France

Bangalore, India

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More Than 150 Yearsof Innovative Strength
The products have evolved, but what drives Sartorius
at its core has remained unchanged since 1870: the goalof simplifying, accelerating and improving methods,
processes and results based on the latest scientificfindings. In this tradition, we contribute to providing
more people with access to better medicine today.

The company’s success began withshort-beam analytical balances, yetover the years, the firm has evolved
from a precision engineering workshop
into an international group.

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Insight

1870

1900

1920

1940

1950

1970

1980

1990

2000

2010

2020+

Company Foundation

New Generation

Developments for the Future

World War II

The German Economic Miracle

Pacesetters

Worldwide Network

Focus on Biopharmaceuticals

Single-Use Technologies

Total Solutions Provider

Simplifying Progress

In 1870, at just 24 years old,

In the 1890s, his craftsmanship

In 1927, Sartorius co-founds a

During World War II, produc-With its traditionally highly

After the successful Apollo 11

Since its foundation, Sartorius

To facilitate sustainable growthSingle-use technologies not only

With in-house developments,

In the future, automation, digi-

Florenz Sartorius founds theand scientific curiosity leadcompany to manufacture novel

tion increasingly switches toskilled workforce, Sartorius

mission in 1969, Sartorius emp-

has been operating interna-and broaden its financial base,make pharmaceutical production

strategic acquisitions andtalization, and networking will

plays its part in the German

loyees analyze 20.2 milligrams

tionally, advertising at trade

Sartorius goes public in 1990.

more environmentally friendly;

a steadily growing productincreasingly shape processes“Feinmechanische Werkstatt

Florenz Sartorius to develop

synthetic membrane filters that

armaments, such as automatic

F. Sartorius” in Göttingen. The

incubators for poultry breeding.

completely retain particles,

devices for releasing sticks of“Wirtschaftswunder” (economicof precious lunar rock to deter­

fairs abroad and concluding

Since the mid-1990s, Sartorius

lower initial investments andrange, Sartorius evolves into

in biopharmaceutical researchcompany soon focuses on a

They are followed by heating

bacteria or other pathogens

bombs from aircraft. Sartorius

miracle): production is resumed

mine its absolute surface. In thebusiness deals in the USA,has been focusing on biotechno-

more flexible processes also

a total solutions provider forand production. Sartorius istechnology Florenz had learned

cabinets for bacteriologicalabove a certain size. The

profits from these orders. The

shortly after the end of the war.

1970s, electronics finally makeFrance and the UK. First withlogy, still a new technology at that

accelerate the production of bio-the entire process chain in thedeveloping solutions centeredabout during his apprenticeshippurposes. Sartorius uses profits

company develops a processcompany also uses forced labor

Against the backdrop of post-

their way into balances andsales offices and later – from thetime. As the first biopharmaceu-

logics, making it less expensive.

biopharmaceutical industry:around artificial intelligenceand continued to develop: hisfrom the balance manufactu-

for large-scale manufacturing.

and prisoners of war. Sartorius

war reconstruction, the demand

simplify the weighing process.

1980s onward – through its own

ticals – such as human insulin –In 2007, Sartorius merges its bio-from molecule development

and is working on assistanceshort-arm analytical balancesring business to buy companies,

With the advent of biotechno-later had independent resear-for high-performance equip-

The portfolio of single-use

production sites, the company

reach market maturity, indus­trial-

technology division with French

to production to final filling

and automated data ma-

reduced the time required

expanding his portfolio withlogy at the end of the 20thchers examine its role during

ment increases. The Selecta

products in membrane filtration

expands its global presence toscale production facilities are

Stedim Biosystems S.A. intoof medical drugs. Milestones,

nagement systems to enable

for precise measurements intheir technologies. Florenz

century, membrane filter tech-

the Nazi era; the results werebalance series is a great successgrows. Pleated filter cartridges

be close to its customers.

needed for the first time.

Sartorius Stedim Biotech — thus

especially with regard to thetechnological breakthroughs

pharmacies and laboratories.

Sartorius’ sons join the businessnology proves to be the core of

published in November 2019.

at home and abroad. Various

are launched on the market,

becoming a global technology

field of advanced therapies,

in biopharmaceuticals andThey win numerous awards atfrom 1906.

today‘s bioprocessing business.

industries discover applications

providing a large filter surface inleader for the biopharmaceuticalinclude the acquisition oflife sciences more quickly andfor membrane filtration.

a compact design.

industry.

selected parts of Danaher‘sefficiently.

international trade fairs.

life science business and theacquisition of BIA Separationsin 2020.

Sartorius Campus, Göttingen

Sartorius Corporate Administration GmbH
Corporate Communications
Otto-Brenner-Straße 20
37079 Göttingen, Germany
www.sartorius.com

Simplifying Progress