Miltenyi Biotec CORPORATE BROCHURE

Miltenyi Biotec CORPORATE BROCHURE

the company
Founded in 1989, Miltenyi Biotec has grown
to over 1,100 employees in 18 countries.

Miltenyi Biotec develops, manufactures, and sells more than 1,000 products and
services for biomedical research; particularly in the fields of cell biology, immunology,
regenerative medicine, and molecular biology. In addition to developing cellular
therapies, Miltenyi Biotec is the leading provider of tools in this exciting area.
Our contract manufacturing divisions manufacture custom biopharmaceuticals,
cellular products, and medical devices.

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Miltenyi Biotec headquarters near Cologne, Germany

Confocal laser scanning microscope images (graphically enhanced) of mature plasmacytoid dendritic cells isolated using the MACS® CD304 (BDCA-4/Neuropilin-1)
MicroBead Kit. Dendritic cells are key initiators of immune responses and therefore are potential targets for vaccination strategies and tolerance induction.

our mission
Our mission is to advance scientific understanding and medicine
by providing tools for biomedical research and cellular therapy.

We are developing cellular therapeutics to meet unmet medical needs and are
committed to delivering the promise of cellular medicine in the fields of organ
regeneration, immune modulation, and transplantation.

Key technologies

• MACS® Technology for cell and biomolecule separation

• CliniMACS® Technology for cinical-scale cell separation applications
• Cell culture, expansion, activation, and differentiation
• Cellular and molecular analysis
• TheraSorb™ Therapeutic Apheresis
• Manufacture of cellular products
• Manufacture of biopharmaceuticals and medical devices
• Transgenic animals

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Miltenyi Biotec CORPORATE BROCHURE

our people
Around the world, Miltenyi Biotec is committed to providing our customers with
the highest quality products for research, clinical, and manufacturing needs.
The technical expertise of our employees is vast. It spans biological and chemical
disciplines, including immunology, cellular and molecular biology, hematology,
regenerative medicine, and organic and inorganic chemistry through physics and
engineering, in­cluding biomedical, electrical, plastics, and software development.

Approximately 30% of our employees work in our R&D

departments, developing new biologics and systems, including
instrumentation for research and clinical applications.

Our clinical and regulatory groups devise regulatory strategies and support regulatory
filings and clinical trials for our clinical products. Our manufacturing groups have
experience in the production of biologics, including antibodies, proteins, peptides,
cells and media, instruments, consumables, and medical devices. Customer support
is provided at multiple levels of the organization: from scientifically trained local sales
representatives, field-based technical support and clinical applications specialists to
country- and headquarters-based technical support, including our R&D groups.

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Capabilities

• Technical expertise: • Worldwide regulatory experience and services:

– Cellular biology and immunology – Development of regulatory strategies
– Molecular biology – Regulatory authority filings
– Chemistry • Quality system, quality assurance
– Physics and engineering (mechanical, electrical, • Clinical trials
biomedical, plastics, software) • Marketing
– Custom tooling • Sales, distribution, logistics
– Bioinformatics • Production of biologics, instruments, and consumables
• cGMP manufacturing

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Miltenyi Biotec CORPORATE BROCHURE

macs® technology
MACS Technology can provide virtually any cell or cell subset
of interest, even very rare cells, for research or cell therapy
purposes, including a variety of stem cells, T cells, NK
(natural killer) cells, dendritic cells, monocytes, and B cells.

MACS Technology enables consistent high-quality cell sorting using either an

automated or manual system—up to 100 million cells per second, with a purity of up
to 99%. In most cases, no further steps are required—even when the cells are used
in cell therapy applications.

MACS Cell Separation

Magnetic labeling: Magnetic separation Elution of the labeled cell fraction

Target cells are magnetically labeled with
MACS MicroBeads (antibody-conjugated
superparamagnetic particles represented
by ). In this case, the purple cells have
been labeled.
Cells labeled with MicroBeads are retained
in the MACS Column due to the presence of
a strong magnetic field and the unlabeled
cells pass through the column. In a deple-
tion procedure the unlabeled cells (orange,
yellow, and green) which pass through the
column are the desired cells.
The column is removed from the magnetic
field and the retained cells are eluted as the
enriched positively selected cell fraction
(the purple cells). In an enrichment proce-
dure, these are the desired cells.

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Left: QuadroMACS™ Separator—manual cell separator for laboratory use. Middle and right: Electron micrographs of CD8+ T cells isolated using
MACS® Technology. Middle: MicroBeads are virtually undetectable on the cell surface and do not alter the properties or function of the cell.
Right: The arrows point to MicroBeads on the cell surface. Images courtesy of Prof. Peter Groscurth, Institute of Anatomy, University of Zurich, Switzerland.

MACS® Technology utilizes submicroscopic particles (MACS® MicroBeads) conjugated

to one or more specific antibodies to isolate cells based on unique antigens on the sur-
face of the cell. Since the MicroBeads are superparamagnetic, they are only magnetic
when placed in a MACS® Column that is then inserted into a MACS® Separator to create
a high–gradient magnetic field.

MACS® MicroBeads are approximately 50 nanometers

— about the size of a virus and significantly smaller than a cell.

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Miltenyi Biotec CORPORATE BROCHURE

Left: One method of protein isolation utilizing MACS® Technology (μMACS™ Streptavidin MicroBeads with a biotinylated DNA capture probe).
Right: autoMACS™ Pro Separator — automated cell sorting of multiple samples at up to 10 million cells per second.

Because MACS MicroBeads are made of a biodegradable matrix and do not alter the
structure, function, or activity of cells, removal of the MicroBeads is not necessary
prior to further experimentation or before clinical applications.

MACS Technology allows rapid isolation of a variety of cell types

— even directly from whole blood and bone marrow.

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 MACS® Technology may also be used for a variety of biomolecule isolations,
including isolation of viruses, transfected cells, epitope-tagged proteins, and
biotinylated molecules and their targets. For molecular biology applications
mRNA can be quickly isolated, and the isolation may also be combined with
in-column cDNA synthesis. MACS Technology also enables the isolation of
enzymes and performance of in-column enzymatic reactions.

Right: An isolated CD133+ cell during cultivation. Cells were selected with the MACS CD133 MicroBead Kit. CD133+ cells can be found in liver, kidney,
muscle, prostate, and neural tissues and have been shown in vitro to be capable of induced differentiation to endothelial cells, neural cells, hepatocytes
(liver), myocytes (muscle), and osteoblasts (bone). CD133+ cells are useful for understanding differentiation pathways and their modulation and might
provide insight into tumor formation. CD133+ cells are currently under investigation for use in stem cell transplantation to reconstitute the hematopoie-
tic (blood and immune) system, as well as for tissue regeneration, including regeneration of heart muscle, peripheral vascular tissue, liver, and kidneys.
CD133+ cells may also have potential applications in the regeneration of skeletal muscles and neural cells. The CD133 antibody and antigen have been
patented by Miltenyi Biotec.

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Miltenyi Biotec CORPORATE BROCHURE

clinical applications
Cellular therapy and the CliniMACS® Cell Separation System*

Cellular therapy is being investigated worldwide to treat various diseases and

conditions. Potential targets of cellular therapy include hematological malignancies,
organ failure, cancer and hereditary, autoimmune and viral diseases.

Miltenyi Biotec develops, manufactures, and sells the CliniMACS Cell Separation
System, an automated system based on MACS® Technology, for enriching target cells
or cell subsets or depleting unwanted cells from a patient or donor’s peripheral blood,
bone marrow, or cord blood. With over 25,000 cell separation procedures performed,
the CliniMACS System has become an important tool in advancing this exciting field
of medicine. The system includes the CliniMACS Instrument and a choice of CliniMACS
Reagents and CliniMACS Tubing Sets, depending on the final cellular composition
desired. The CliniMACS System enables the depletion of unwanted cells or the isola-
tion of highly pure cellular products. These cellular products can be administered
directly to a patient or further manipulated prior to delivery.
(* see back cover for regulatory notes)

CD133+ cells isolated from mobilized blood were cultured and differentiated into neural-like cells. CD133+ cells are useful for understanding
differentiation pathways and their modulation. They may also have potential applications in the regeneration of neural cells. Left: Astrocyte-like cells.
Middle: Oligodendrocyte-like cells. Right: Neuronal-like cells. Magnification is 200×. Images courtesy of Dr. Selim Kuçi, Tübingen, Germany.

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The CliniMACS® Cell Separation System — cell sorting up to 100 million cells per second in a closed, sterile system.

Several CliniMACS Reagents utilize antibodies that are proprietary to Miltenyi Biotec,
including CD133, CD1c (BDCA-1), and CD304 (BDCA-4). CD133-selected stem cells may
have greater regenerative potential than other types of adult stem cells. Early clinical
trials involving more than 150 patients have shown statistically significant improve-
ment in heart function when CD133+ cells are administered after myocardial infarction.

CliniMACS CD1c (BDCA-1)-Biotin and CD304 (BDCA-4) MicroBeads

are suited for isolating myeloid and plasmacytoid dendritic cells,
respectively, directly from peripheral blood, without the need for
generating dendritic cells from monocytes.

In addition, the proprietary CliniMACS Cytokine Capture System (IFN-gamma) can

isolate antigen-specific T cells, which are being investigated for adoptive immuno-
therapy. Other CliniMACS Reagents target several types of T cells, CD34+ stem cells,
NK (natural killer) cells, monocytes, and B cells. A flexible labeling system for use
with any primary biotinylated antibody is also available.

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Miltenyi Biotec CORPORATE BROCHURE

CD133+ cells isolated from mobilized blood were cultured and differentiated into hepatocyte-like (liver) cells. CD133+ cells are currently under
investigation for use in tissue regeneration. CD133+ cells are also useful for understanding differentiation pathways and their modulation.
Magnification is 200×. Images courtesy of Dr. Selim Kuçi, Tübingen, Germany.

Miltenyi Biotec is currently sponsoring clinical trials for several of its products in
hematological malignancies and cardiac tissue regeneration in the United States.
In addition, the company is supporting more than 35 cell therapy clinical trials
(mainly in the United States and Europe) for a wide variety of applications.

Clinical trial applications include:

• Hematopoietic stem cell transplant (cancer and autoimmune diseases);
• Regenerative medicine (heart and vascular tissue, liver, kidney, and cells of the
nervous system);
• Adoptive immunotherapy (antigen-specific T cells for immunocompromised
patients with cytomegalovirus, adenovirus, Epstein-Barr virus, and cancer),
particularly following allogeneic stem cell transplantation and organ transplant;
• Regulatory T cell therapy (allogeneic stem cell transplantation, autoimmune
diseases and cancer);
• Dendritic cell therapy (cancer and viruses);
• Gene therapy (hereditary defects, AIDS and cancer).

Miltenyi Biotec is excited to work with many of the leading researchers and companies
around the world to advance this emerging field and develop products that address
significant unmet medical needs.
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TheraSorb™ Therapeutic Apheresis

The TheraSorb Therapeutic Apheresis System* is a system directly connected to a

patient, designed to remove pathogenic substances from human plasma by immuno-
adsorption. The system consists of the LIFE 18™ Apheresis Unit and a pair of adsorbers
for capturing the undesirable substances. Adsorbers are currently available for the
following applications:
• Removal of LDL and Lp(a), a possible treatment for patients suffering from severe
hypercholesterolemia;
• Removal of pathogenic antibodies, a potential therapy for patients suffering from
autoimmune diseases and organ transplant rejection or as a pre-treatment
before transplantation;
• Removal of fibrinogen, fibrin, and C-reactive protein, a possible therapy for
treating microcirculation disorders and ischemic tissue damage.
* TheraSorb Products are not available in the United States.

LIFE 18 Apheresis Unit

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Miltenyi Biotec CORPORATE BROCHURE

cell analysis tools

Miltenyi Biotec offers a selection of products and services for
in vitro cell analysis to support basic and cell therapy research.

More than 200 fluorochrome-conjugated antibodies are available for flow cytometry
applications. The MACSQuant™ Analyzer, a compact flow cytometer, will be released
in 2008. The analyzer, with its bar code reader for identifying reagents and setting
programmed features, will make immunofluorescent analysis and quantitation of cells
fast and uncomplicated, even for those with no flow cytometry experience.

MACS® Cytokine Secretion Assay technology enables the analysis and enumeration
of viable cytokine-secreting leukocytes, particularly antigen-specific T cells by flow
cytometry. The cytokine-secreting cells can be magnetically enriched using MACS
Technology, resulting in detection frequencies of cells as low as one cell in a million.
Importantly, function is not altered in cells isolated using this system, making them
available for downstream applications.

Miltenyi Biotec also offers several products for tumor cell detection and enrichment
from blood or bone marrow for research use, including carcinoma, melanoma, and
epithelial tumor cells.

CD133+ cells isolated from mobilized blood were cultured and differentiated into skeletal muscle-like cells. CD133+ cells are currently under investigation
for use in tissue regeneration. CD133+ cells are also useful for understanding differentiation pathways and their modulation. Magnification is 200×.
Images courtesy of Dr. Selim Kuçi, Tübingen, Germany.

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MACSQuant™ Analyzer — a state-of-the-art flow cytometer

Many of the Miltenyi Biotec cell analysis tools can also be manufactured
as in vitro diagnostics or for quality control of cellular therapeutics.

Miltenyi Biotec also provides gene expression profiling services based on our own
topic-defined and custom microarrays or Agilent whole genome microarrays.
Additionally, for samples with very few cells, the SuperAmp™ Service enables gene
expression profiling with as little as one cell. Bioinformatics services are also available
in conjunction with the gene expression profiling services or as stand-alone services.

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Miltenyi Biotec CORPORATE BROCHURE

macs® cell culture

Miltenyi Biotec has developed a portfolio of products
dedicated to culturing, expanding, and analyzing cells.

These products include media, activation and stimulation agents, and culture bags.
We are also developing instrumentation for expanding and differentiating cells.

The products may be incorporated into processes for the manufacture of cellular
therapeutics and biopharmaceuticals, as well as benchtop research. In addition,
we can customize the products for specific applications.

We produce a variety of cell culture media for cell expansion, differentiation, cell
analysis, and for biopharmaceutical production; including media which contain com-
plex formulations and recombinant cytokines. Stem cell differentiation and expansion,
T cell activation and expansion, and culturing of dendritic cells are among the appli-
cations for which we have media available. We are continuing to develop applica-
tion-specific media for cell expansion and differentiation research, as well as for the
manufacture of cells for cell therapy applications.

Two natural killer (NK) cells attacking a tumor cell. NK cells are the first line defense against viral infections and solid tumors. Clinical trials are under way
to investigate the potential of NK cells in leukemia patients to induce graft versus leukemia effect following stem cell transplantation. The image was
taken on a Zeiss epiluminescent microscope fitted with a Sony CCD at 400× magnification. Image courtesy of Dr. Mark W. Lowdell, The Royal Free and
University College Medical School, London, UK.

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Miltenyi Biotec also manufactures a variety of recombinant GMP
cytokines and antigens, including recombinant proteins and
peptide pools, and is continuing to develop additional products in
this field. To activate and expand T cells, Miltenyi Biotec offers both
MACSiBead™ Particles and CytoStim, which mimics a superantigen.

We produce culture bags for cells with adherent or non-adherent properties.

Our T cell expansion bags are unique, having multiple compartments and breakable
seals for expanding cell culture volumes. Miltenyi Biotec also offers cell culture and
freezing bags.

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Miltenyi Biotec CORPORATE BROCHURE

industrial services
Contract manufacturing

Miltenyi Bioprocess, the contract manufacturing division of Miltenyi Biotec, provides

a full range of services for the development and manufacture of biopharmaceuticals,
affinity matrices, GMP media and solutions, and medical devices.

Our biopharmaceutical experience includes the production of recombinant proteins

(antibodies, antigens, and cytokines) in prokaryotic and eukaryotic expression systems.
Antibodies may be humanized utilizing our patented transgenic mice. We also offer
aseptic filling, lyophilization, and finishing of formulated bulk material.

We design and manufacture custom reagents and disposables for the CliniMACS®
Cell Separation System. Based on our extensive experience in cell processing, we can
develop and manufacture custom closed systems to meet virtually any cell process-
ing need, including cell washing, cell culture, cell expansion, and activation and gene
transduction.

In conjunction with contract manufacturing, the services of our QC, QA, and Regulatory
Affairs professionals are also available.

GMP manufacturing facility in Teterow (Mecklenburg-West Pomerania), Germany

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Aseptic vial filling station

Cell processing
The Miltenyi Biotec Cellular Products Division provides the biotech industry and
clinicians with clinical-grade cellular products for clinical applications within Europe.
These cellular products include cells derived from bone marrow, peripheral blood, and
cord blood; including CD133+ stem cells and antigen-specific T cells against viruses or
tumors. The Cellular Products Division also has experience in genetically transducing
cells and can transduce cells for gene therapy clinical trials.

Gene expression profiling and bioinformatics services

Miltenyi Biotec offers gene expression profiling services using our own topic-defined
or custom PIQOR™ Microarrays or Agilent whole genome microarrays. The additional
SuperAmp™ Service overcomes the problem of having only a few cells to analyze and
enables gene expression profiling with as little as one cell. Bioinformatics services are
also available, with or without gene expression profiling.

Transgenic animals
Miltenyi Biotec provides a variety of transgenic mouse models for research use and for
production of commercial products, including knockout mice for generating chimeric
antibodies with human constant regions and against highly conserved targets. We can
also develop chimeric antibodies on a contract basis.

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Miltenyi Biotec CORPORATE BROCHURE

SALES and DISTRIBUTION

Miltenyi Biotec sells products directly in 18 countries in North America, Europe, and
Asia/Pacific. In addition, an extensive distributor network supports our products in
37 additional countries.

In many of our major markets, Miltenyi Biotec can deliver

products within 24 hours. In 2007, we introduced a web shop
to enable customers to order products over the internet.

Miltenyi Biotec employs a worldwide SAP® system to control internal processes,

including production, finance, sales, and distribution. The company maintains
product inventory on four continents.

Miltenyi Biotec Inc., Auburn, California, USA

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Miltenyi Biotec direct sales Miltenyi Biotec offices

Sales through distributors Miltenyi Biotec headquarters

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Miltenyi Biotec CORPORATE BROCHURE

growth strategies
Our goal is to continue to be the leading provider of
products for cell biology, immunology, and regenerative
medicine and tools for cell therapy applications.

In-house development

The 300 members of our R&D teams are actively engaged in all phases of product
development—from the discovery of monoclonal antibodies to the design of
complete systems combining cell isolation and culture. Each year we release more
than 100 products developed at Miltenyi Biotec, including reagents and instruments.

Our belief in the promise of cellular therapy has led us to focus our research on
optimizing cell populations for transplantation and tissue regeneration, as well as for
immunotherapies, including adoptive immunotherapy, regulatory T cell suppression,
and dendritic cell therapy. Our tissue regeneration effort includes the development of
media, cytokines, and other additives for differentiation and expansion of progenitor
cells into transplantable tissue. As part of our immunotherapy program we are also
developing recombinant proteins and peptide pools for antigen presentation, as well
as molecules for activation and expansion.

Representative SPECT (single-photon emission computed tomographic) scans from a patient in a clinical trial who underwent bypass surgery, as well
as injection of CD133+ stem cells isolated using the CliniMACS® System in the posterior wall infarction area. From left to right: preoperative and 2 weeks,
6 months, and 1 year postoperative. The arrows indicate the site of injection of the CD133+ stem cells. At 2 weeks, tracer activity in the infarct area was
still diminished, but at 6 months (second from right), perfusion had virtually returned to normal and remained normal at 1 year.
Courtesy of Prof. Gustav Steinhoff, Rostock, Germany.

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 We expect to begin clinical studies soon with our patented CD 303 (BDCA-2) antibody,
recognizing a novel plasmacytoid dendritic cell–specific type II C-type lectin, for inhi-
bition of type I interferon production. Preclinical testing suggests that this molecule
may be useful in the treatment of autoimmune diseases, including systemic lupus
erythematosus, psoriasis, and rheumatoid arthritis and for tolerance induction.

Partnering
In the past few years, we have developed and manufactured products for United
States and European companies, including products for clinical trials. We can assist in
all phases of development and manufacturing and welcome discussions regarding
co-development of products utilizing our technology.

Product distribution
Miltenyi Biotec is well-positioned to meet product distribution needs with a direct
sales organization in 18 countries and a distribution network in 37 additional coun-
tries including the United States, Canada, Europe, Asia, Latin America, and the Middle
East. We continue to be interested in distributing products for cell isolation, culture
and expansion, activation, differentiation, and analysis for both research and clinical
applications.

Acquisitions
We have obtained certain of our technology and several of our facilities through
acquisitions. These include our GMP manufacturing facilities in Teterow, Germany;
TheraSorb™ Therapeutic Apheresis technology; and the gene expression profiling and
bioinformatics program. We plan to make further acquisitions in fields related to our
current business.

Licensing
Miltenyi Biotec continues to have interest in in-licensing technology related to our
strategic focus. We are also open to licensing Miltenyi Biotec developments to parties
with the resources and commitment to further develop and commercialize them.

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Germany/Austria/ Benelux Italy Spain
Switzerland Miltenyi Biotec B.V. Miltenyi Biotec S.r.l. Miltenyi Biotec S.L.
Miltenyi Biotec GmbH Postbus 85183 Via Persicetana, 2/D C/Luis Buñuel 2,
Friedrich-Ebert-Straße 68 3508 AD Utrecht 40012 Calderara di Reno (BO) Ciudad de la Imagen
51429 Bergisch Gladbach Netherlands Phone +39 051 6 460 411 28223 Pozuelo de Alarcón (Madrid)
Germany Phone +32 9 244 0554 Fax +39 051 6 460 499 Phone +34 91 512 12 90
Phone +49 2204 8306-0 macs@miltenyibiotec.nl macs@miltenyibiotec.it Fax +34 91 512 12 91
Fax +49 2204 85197 macs@miltenyibiotec.es
macs@miltenyibiotec.de China Japan
Miltenyi Biotec Shanghai Office Miltenyi Biotec K.K. United Kingdom
USA/Canada Fareast International Plaza A Nittsu-Eitai Building 5F Miltenyi Biotec Ltd.
Miltenyi Biotec Inc. Rm. 2301, No. 319 Xianxia Rd. 16-10 Fuyuki, Koto-ku, Tokyo, Almac House, Church Lane,
12740 Earhart Avenue Shanghai 200051, P.R.China 135-0041, Japan Bisley, Surrey GU24 9DR
Auburn, CA 95602 Phone +86 21 62351005 Phone +81 3 5646 8910 Phone +44 1483 799 800
Phone 800 FOR MACS Fax +86 21 62350953 Fax +81 3 5646 8911 Fax +44 1483 799 811
Phone +1 530 888 8871 miltenyibiotec@china.com macs@miltenyibiotec.jp macs@miltenyibiotec.co.uk
Fax +1 530 888 8925
macs@miltenyibiotec.com France Singapore
Miltenyi Biotec SAS Miltenyi Biotec Asia Pacific Pte Ltd.
Australia 10 rue Mercoeur 100 Beach Road
Miltenyi Biotec Australia Pty. Ltd. 75011 Paris #28-06 to 28-08 Shaw Tower
Unit 16A, 2 Eden Park Drive Phone +33 1 56 98 16 16 Singapore 189702
North Ryde NSW 2113 Fax +33 1 56 98 16 17 Phone +65 6238 8183
Phone +61 02 8877 7400 macs@miltenyibiotec.fr Fax +65 6238 0302
Fax +61 02 9889 5044 macs@miltenyibiotec.com.sg
macs@miltenyibiotec.com.au

www.miltenyibiotec.com

The CliniMACS® System components (Reagents, Tubing Sets, Instruments and PBS/EDTA Buffer)
are manufactured and controlled under an ISO 13485 certified quality system.
In Europe, the CliniMACS System components are available as CE-marked devices.
In the USA, the CliniMACS System components including the CliniMACS Reagents are available for use
only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
CliniMACS® MicroBeads are for research use only and not for use in humans.
MACS and CliniMACS are registered trademarks of Miltenyi Biotec GmbH. autoMACS, LIFE 18, MACSiBead,
MACSQuant, μMACS, PIQOR, QuadroMACS, SuperAmp, and TheraSorb are trademarks of Miltenyi Biotec GmbH.

130-092-209.04
On the cover: Rendered scanning electronic microscope images of dendritic and T cells. Dendritic cells are key
initiators of immune responses and therefore are potential targets for vaccination strategies and tolerance
induction. T cells are major effectors of the immune system. Potential applications include the transfer of immune
cells from one person to another to confer immunity and the up- or down-regulation of the immune system to
fight cancer, overcome viruses, and treat autoimmune diseases.

© 2008 Miltenyi Biotec GmbH