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BioTOP-Report

2014

Biotech and Pharma in Berlin-Brandenburg

(2)

BioTOPics 47 | May 2014 BioTOP-Report 2014

Editorial

The German Capital Region – Biotechnology and Life Sciences are Ready for the Future

3

Biotechnology

The Capital Region – New Jobs and New Companies

4

Pharma

Attractive Location

14

Glycoscience

Glyco Research for Innovations in Health Industry

18

Bioelectronics

The Joint Lab Bioelectronics – A New Platform for the Integration of Microelectronics into Life Sciences 20

Business Location

Excellent Services for Berlin-Brandenburg

24

Spotlight on European Business and Internationalization

The Enterprise Europe Network Berlin-Brandenburg

26

Biotech Parks

The BioCampus Network Berlin-Brandenburg

34

Addresses 39

Publisher: Berlin Partner für Wirtschaft und Technologie GmbH · BioTOP Berlin-Brandenburg

Fasanenstraße 85 · 10623 Berlin · Germany · Phone +49 30 318622–0 · Fax +49 30 318622–22 · biotop@biotop.de · www.healthcapital.de

Editor: Volker Erb

Design & Production: webersupiran.berlin

Translation: Kate Abbott · Berlin

Photos/Figures: BioTOP or authors and:

Page 14 Paulus Rusyanto/dreamstime.com, Sean Pavone/dreamstime.com Page 21 Warenemy/dreamstime.com, Collpicto/dreamstime.com Page 27 adimas/Fotolia (Profile Alacris), Noah Clayton/co.don (Profile co.don) Page 30 Werner Popp (Profile organobalance).

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3

BioTOPics 47 | May 2014

BioTOP-Report 2014

Editorial

The German Capital Region – Biotechnology and

Life Sciences are Ready for the Future

Berlin-Brandenburg is an extremely attractive location for research and its translation into industrial applications.

The establishment of the Berlin Institute of Health, successful spin-offs and inward investment show that the

Ger-man capital region provides top conditions for the healthcare industry. Berlin is the start-up capital of GerGer-many!

With its new “Healthcare Industries” master plan, the capital

re-gion is setting the course for the sector’s development until 2018.

Basic research, innovation, spin-offs and application – in the

fu-ture, these will remain the four pillars that determine the

success-ful implementation of the cluster strategy in Berlin-Brandenburg.

Biotechnology/pharmaceuticals, medical technology and the

healthcare industries are the focal areas. In the coming years,

biotechnology/pharmaceuticals development will feature:

The creation of new translation platforms in basic research,

clinical research and industrial biotechnology

Max Planck and Fraunhofer Research, as well as the Helmholtz

and Leibnitz Institutes, are drivers of technology transfer and

pio-neers of innovative technologies and products.

Concentration on therapy development through new system

medicine strategies

The Max Delbrück Center for Molecular Medicine and Charité –

Universitätsmedizin Berlin are the umbrella for the new flagship of

German biomedicine.

In diagnostics, focus on the development of companion

diag-nostics

Laboratory medicine, applied research, SMEs and the

pharma-ceuticals industry are pooling their activities for therapy

optimiza-tion in personalized medicine.

In regenerative medicine, concentration on the development of

new cell therapies

The Berlin-Brandenburg Center for Regenerative Therapies

(BCRT), biotechnology SMEs and pharmaceuticals partners in

the international Regenerative Medicine Coalition are part of a

high-performance product development network.

Focus on the sustainable use of biological resources for

medi-cal applications in industrial biotechnology

The Leibniz Institute for Agricultural Engineering, university-related

research and biotechnology SMEs are successfully implementing

the federal government’s bioeconomics strategy and contributing

to the strength of the healthcare industries.

Development of new growth fields in the life sciences with

inter-disciplinary technologies

Cross innovation at the interface of microsystems technology,

mi-croelectronics, photonics and surface engineering and thin films

open up completely new opportunities for analytics, automation

and hardware development and along with this, for growth, value

creation and cost reduction.

Value chain expansion via inward investment and industrial

location expansion

With more than 200 biotechnology companies, over 30 research

institutions and over 130 clinics and hospitals,

Berlin-Branden-burg is already a European hot spot for the life sciences. Growth

in expertise, players and investment will reinforce the capital

re-gion’s leading position in the international markets.

This new edition of the BioTOP Report provides you with an

ex-citing, informative overview of the development in the capital

re-gion’s industries. With themes such as glyco-engineering

technol-ogy and bioelectronics, it underscores internationally outstanding

activities. We wish you reading pleasure and invite you to commit

to Berlin-Brandenburg as a place to develop your business.

Reach out and contact us!

Prof. Dr. Peter Seeberger

Dr. Günter Peine

Expert Circle Spokesman

Head of

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BioTOPics 47 | May 2014 BioTOP-Report Biotechnology

JANUARY 2013

Epigenomics AG hands in fourth module at FDA completes application for approval as planned +++ co.don® AG applied for approval of joint cartilage

product chondrosphere® in the EU +++ Shire discovered the Munich-based RNA

specialist Ethris for itself. In cooperation the two companies want to find therapies for rare diseases

FEBRUARY 2013

Epigenomics receives notice about grant of priority review status and accep-tance of the hand-in of the PMA application for Epi proColon® from the FDA +++

Innovation forum “Biopolymers and Bio-based Plastics” in Schwarz heide

MARCH 2013

BIOTECON Diagnostics GmbH extends its robot segment +++ Epigenomics AG collects 5,0 million Euros through capital increase +++ New research collective INNO-TRACE develops innovative contrast agents for tumour imaging

APRIL 2013

Europe's largest clinical laboratory at Campus Virchow-Klinikum: Labor Berlin inaugurates new site

MAY 2013

Bayer HealthCare presents new incubator model for biotech start-ups in Berlin

JUNE 2013

Alacris Theranostics GmbH announces Illumina CSPro certificate for next gen-eration sequencing +++ Humedics co-founder Martin Stockmann receives Von-Langenbeck Prize for development of LiMAx test

JULY 13

Berlin-Brandenburg Healthcare Industries cluster HealthCapital launches new website: www.healthcapital.de +++ Caprotec expands alliance with Bayer +++

EZAG AG in participation via subsidiary OctreoPharm Sciences GmbH +++ cap-rotec bioanalytics GmbH and Bayer CropScience enter into second research collaboration +++ NOXXON Pharma completes patient recruitment for phase IIa study in diabetic nephropathy +++ Romer Labs® and the Institute for Product

Quality (ifp) launch new AgraQuant® F.A.S.T.

AUGUST 13

Bayer HealthCare concludes partnership and license agreement with Compu-gen Ltd. for the research, development and marketing of antibody-based drugs for cancer immunotherapy. +++ caprotec bioanalytics GmbH and Syngenta Inter-national AG announce research collaboration +++ Epigenomics AG agreement with YA Global Master SPV Ltd. brings funding of up to €5 million

SEPTEMBER 13

Eckert & Ziegler BEBIG s.a. takes over prostate cancer implantation business of American company Biocompatibles Inc. for $5 million +++ Myelo Therapeutics GmbH successfully completes funding round for the development of adjuvant cancer therapy

OCTOBER 13

Epigenomics and Polymedco sign commercialization agreement for Epi proCo-lon® for the North American market +++ Sugar is life: GlycoUniverse successfully

launched in Campus Buch +++ Cell Medica, a leading company in the T-cell

Biotechnology

The Capital Region – New Jobs and New Companies

The growth trend of recent years continues in 2013. Employee numbers have grown by 5.6 % (last year, 6.5 %).

Currently, 232 companies employ 4,586 people. The constant momentum is accompanied by many newly founded

businesses.

k

According to the latest BioTOP survey, 232 biotechnology

companies are active in the Berlin-Brandenburg region. This

means the company base has expanded by a total of 10

companies against last year.

k

A total of 14 companies have stopped doing business in the

region, either shutting down completely or relocating.

k

The addition of 24 companies more than compensated for

this loss. Of the new companies, we count 6 additions due

to inward investment and new registration and – particularly

notable – 18 start-ups.

k

The current base of 232 companies has created 352 new jobs.

This translates into a growth rate of over 8 percent.

k

After subtracting the 114 jobs lost due to business shut-downs,

the sector in the region gained a total of 273 jobs, adding up

to regional employment growth of 5.6 % in the sector.

For many years, biotechnology region Berlin-Brandenburg has

been on a steady growth course. One of the sector’s leading

re-gions in Germany and Europe, it hosted 18 start-ups last year

alone – a figure to note. This speaks volumes in favor of the

loca-tion’s general conditions and the commitment of the many players

involved and their start-up-related activities. And above all,

un-derscores the courage of the many company founders who are

seeking their fortune in this highly sophisticated sector.

Smaller companies dominate the region’s business landscape:

139 companies in the sector have less than 10 employees. Only

13% of the total jobs are located in these companies, however.

Over 53% of the sector’s employees in the region work for the 19

companies with more than 50 employees.

The majority of these companies (88%) focus on the areas of new

therapeutic agents, diagnostic products and biopharmaceuticals

services; followed by 19% in the agriculture/food sectors and 13%

in the industrial biotechnology sector (multiple mentions).

The start-ups still have little effect on the job market. At their

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5

BioTOPics 47 | 6. Juni 2014 (3:02)

BioTOP-Report Biotechnology

Key milestones achieved

MOLOGEN

completed a successful fiscal year 2013 with three

different product candidates in clinical development for the first

time. The final evaluations for the completed clinical trials of

MGN1703 and MGN1601 provided very positive data, and with

MGN1404 (a product that combats malignant melanoma), the

company launched the clinical development phase of another

product candidate within the framework of a partnership,

contrib-uting to an expansion of its pipeline. For its most advanced

prod-uct candidate, the cancer immunotherapy MGN1703, MOLOGEN

was also able to present very positive clinical data from the final

evaluation of a phase II trial in colorectal cancer (IMPACT study)

in 2013. For the most part, the preparations for a phase III pivotal

study in this indication were completed in the course of the last

fiscal year.

Glycotope

specializes in the glycosylation of proteins. Glycotope

has a broad portfolio of drugs in clinical development, including

the new cancer drugs, PankoMab-GEX™ and CetuGEX™, both

in phase IIb trials. PankoMab-GEX™ is the first fully glycosylated

and glyco-optimized human antibody for a novel tumor-specific

carbohydrate-protein mixed epitope (TA-MUC1) abundantly

pres-ent in a larger set of tumor indications, metastases and cancer

stem cells. Additional Glycotope products include TrasGEX™,

which has successfully completed its phase I/IIa trial and the

im-proved fertility hormone FSH-GEX™, which is expected to begin

two phase III clinical trials in 2014.

Biopharmaceuticals company

NOXXON Pharma

is a pioneer in

the development of a new class of proprietary therapeutic agents

called “Spiegelmers,” which are chemically synthesized

L-ste-Dr. Matthias Schroff

CEO MOLOGEN AG

We are well aware that our company’s success is also due to

the conditions that Berlin and the capital region offer.

Wheth-er research collaboration (FU BWheth-erlin) or clinical studies with

Charité Universitätsmedizin and its departments – we benefit

from the close scientific network. The availability of qualified

personell is also a key advantage, which surely ties into the

high quality of life in Berlin. Berlin is a city for conferences

and conventions and many of our sector associations have

their headquarters here. This is another reason why Berlin is

an excellent location for medical biotechnology. As a research

company, we appreciate the fact that Berlin is one of the

world's leading regions and innovative locations in the field

of life sciences.

therapy field, opens a central European production facility in Berlin-Buch +++

ProBioGen upholds strong patent position in viral vaccine manufacturing field

NOVEMBER 13

Glycotopes Fully Human and Glycooptimized Recombinant FSH-GEX exhibits superior activity and excellent tolerability in phase II clinical trial for in vitro fertilization +++ The methylated SHOX2 biomarker from Epigenomics shows promising results for therapy-related monitoring of lung cancer patients +++

SCIENION´s sciFLEXARRAYER receives product technology innovation award from Materials Science Society AVS +++ The NeuroPro Alliance, a joint ven-ture between the Technical University of Applied Sciences Wildau, nanoPET Pharma GmbH and AudioCure Pharma GmbH, receives research award.

DECEMBER 13

OMEICOS Therapeutics: new drug for atrial fibrillation in model systems tests positively +++ Contichrom® systems from KNAUER receive

Berlin-Branden-burg Innovation Award +++ ProBioGen announces expansion of commercial licenses with emergent biosolutions for AGE1.CR® viral vaccine manufacturing

production platform

JANUARY 14

Improved diagnostics for sepsis-associated liver dysfunction with LiMAx test from Humedics GmbH +++ Epigenomics starts trading on US OTCQX mar-ket +++ Cell Medica announces European Union orphan drug designation for Cytovir ADV +++ ward-winning Ostendum Lab-on-a-Chip nanodevices are pro-duced with SCIENION's sciFLEXARRAYER SX

FEBRUARY 14

The Swedish-German company Amal Therapeutics SA has acquired investors for a seed financing round +++ mivenion GmbH receives FDA approval for Xiralite® Fluorescence Imaging System X4 for microcirculation visualization +++

€15 million for Mologen

MARCH 14

Glycotope GmbH raises €55 million +++ FDA Advisory Committee Provides Recommendations for Epigenomics' Colorectal Cancer Screening Blood Test

APRIL 14

Alacris Theranostics GmbH announces partnership with Walldorfer SAP AG

+++ On May 14, Bayer HealthCare opened its first German CoLaborator in Berlin-Mitte on the company's premises +++ Bayer Pharma AG participates in the High-Tech Startup Fund II +++ International pharmaceutical company Takeda extends production facility in Oranienburg

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BioTOPics 47 | May 2014 BioTOP-Report Biotechnology 0 100 200 300 400 500 600 700 800 900 1.000 1.100 1.200 1.300 1.400 1.500 1.600 1.700 1.800 1.900 2.000 2.100 2.200 2.300 2.400 2.500 139 companies 1-10 employees

Number of Employees According to Company Size

74 companies 11-50 employees 19 companies > 51 employees

'04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 Number of emplo yees

602

1.542

2.442

In comparison to the previous year, the average number of employees per company decreased by 9,2 % in the 1-10 category and increased 15,9 % in the 11-50 category. The average number of employees in the category > 50 employees increased by 3,7 %. (Source: Own survey, BioTOP database, 232 companies questioned, February 2014)

reoisomer RNA aptamers and a non-immunogenic alternative

to antibodies. NOXXON is approaching the completion of

multi-ple proof-of-concept studies with a diversified portfolio of

clini-cal-stage Spiegelmer

®

therapeutic agents exhibiting high safety

and tolerability, and promising signs of efficacy. Emapticap pegol

(NOX-E36), an anti-CCL2/MCP-1 Spiegelmer

®

, is currently in a

phase IIa study in patients with diabetic nephropathy. Olaptesed

pegol (NOX-A12), an anti-CXCL12/SDF-1 Spiegelmer

®

, is

cur-rently in phase IIa studies in two hematological cancers: multiple

myeloma and chronic lymphocytic leukemia. Lexaptepid pegol

(NOX-H94), an anti-hepcidin Spiegelmer

®

, has shown efficacy in

a subset of anemic cancer patients with functional iron deficiency

in a pilot study where the pharmacodynamic parameters of iron

metabolism and erythropoiesis were positively influenced and

hemoglobin levels increased following lexaptepid mono-therapy.

The product will also be evaluated in a phase IIa study in dialysis

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7

BioTOPics 47 | May 2014 BioTOP-Report Biotechnology 0 500 1.000 1.500 2.000 2.500 3.000 3.500 4.000 4.500 5.000 '13

Employees in Biotech SMEs

'04 '05 '06 '07 '08 '09 '10 '11 '12

Number of

emplo

yees

4.586

Employment rose to 4.586 in 2013. This is a growth of 5,6 % in comparison to the previous year. The number of companies went up to 232, reflecting the arrival of 24 companies (18 start-ups) and 14 departures. (Source: Internal survey, BioTOP database, 232 companies questioned, February 2014)

Epigenomics

, a molecular diagnostics company in the process

of developing and commercializing a pipeline of proprietary

products for the screening and diagnosis of cancer, announced

the outcome of a meeting of the Molecular and Clinical Genetics

Panel of the FDA’s Medical Devices Advisory Committee held in

conjunction with its premarket approval for its blood-based

col-orectal cancer screening test Epi proColon

®

. The members of the

Medical Devices Advisory Committee voted favorably,

determin-ing that the benefits of Epi proColon

®

do outweigh the risks for use

in patients who meet the criteria.

Caprotec bioanalytics

and Syngenta International AG announced

a joint research agreement in which Syngenta will gain access

to caprotec’s proprietary capture compound mass

spectrome-try technology. The companies will work together to profile the

interactions of one of Syngenta’s novel active compounds with

the proteome in its relevant plant biological system. caprotec’s

platform enables the unbiased evaluation of the interactions of

small molecules with protein mixtures in a targeted and directed

manner, which facilitates the identification and elucidation of

trac-table targets and accelerates the development of promising leads.

Cell Medica

announced that the European Medicines Agency

(EMA) Committee for Orphan Medicinal Products has issued a

positive opinion on an application for orphan designation of a

novel T cell immunotherapy under development by the company.

The cell therapy Cytovir ADV targets the treatment of adenovirus

infections in patients following allogeneic hematopoietic stem cell

(bone marrow) transplant. It is comprised of adenovirus-specific T

cells derived from allogeneic donor leukocytes, expanded ex vivo.

co.don

is one of the world’s leading specialists in the cultivation

of cells for the joint-preserving treatment of articular cartilage and

intervertebral disk defects. Using the company’s patented

thera-peutic products, doctors are able to avoid joint and intervertebral

disk prostheses in many cases. An increasing number of

orthope-dists, orthopedic surgeons and neurosurgeons are relying on this

regenerative therapeutic procedure. This minimally invasive

meth-od for articular cartilage regeneration has been successful with

approx. 6,000 patients in Germany. Experts estimate the overall

European market to have a potential annual worth of approx. €1.2

billion. With its current infusion of capital, co.don is paving the

way for the EU-wide approval of its biological therapeutic co.don

chondrotransplant

®

DISC – an autologous method for treating

in-tervertebral disk damage.

MetrioPharm

was able to complete the regulatory pre-clinical

study package. The most important outcome was MP1032’s

superior safety profile as confirmed by the results from the

var-ious regulatory pharmacology and toxicology studies conducted

throughout the past year. The results of these tests surpassed

all ambitious expectations. Repeated daily administration of up

to 150(!) times the normal therapeutic dose for 28 consecutive

days did not cause any side-effects or adverse events whatsoever.

A clean safety profile is a highly valuable asset for a new drug.

With the impeccable animal safety data obtained for MP1032 an

important foundation for entering clinical Phase I trials in 2014

was laid. For the first time, MP1032 can now be tested directly in

humans.

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BioTOPics 47 | May 2014 BioTOP-Report Biotechnology

ProBioGen

is an internationally operating technology

provid-er and contract development and manufacturing organization

(CDMO) with almost 20 years of experience in cell culture,

pro-cess development and GMP manufacturing. A competent and

reliable CDMO partner, ProBioGen offers customized solutions

for even the most challenging development and manufacturing

requirements. ProBioGen has signed its latest GlymaxX

®

ADCC

technology deal with a top-10 pharmaceuticals company for a

therapeutic antibody platform.

Investment in the Region

In recent months, these companies have acquired financing of

almost €100 million. Glycotope GmbH has led the field with a

new financing round of €55 million. Investors have supplied the

company with €130 million in the past few years. One of the

larg-est in Europe, the latlarg-est round of financing has attracted

inter-national attention. It will be exciting to see how Glycotope’s

fu-ture develops. The listed companies have also obtained a new

infusion of money. Mologen and Epigenomics have been able to

financially safeguard their next steps with new capital increases,

for example. High-Tech Gründerfonds (HTGF) and IBB

Beteiligu-ngsgesellschaft, one of the most active venture capital financiers

in Germany, were among the most responsive financiers in the

early-stage area again in 2013. Subsidies from the states of

Ber-lin and Brandenburg, which contributed project-related funding

volumes of 42 Mio. Euro to life sciences companies alone,

supple-mented private funding. Investment helps not only the companies

involved, but is also relevant for the development of the overall

biotechnology region, generating useful growth effects above and

beyond its benefits to individual companies.

Conclusion

The Berlin-Brandenburg biotechnology region has enjoyed a

con-stant growth trend for years. The companies in the sector have

again proven their competitiveness in 2013/2014. After many years

of developing products and conducting the studies required by

the certifying authorities, the near future will show whether the

investments have paid off. Most of the biopharmaceutical

com-panies are doing so well that is safe to be optimistic, although the

risk remains high. The region’s pool of highly specialized service

providers is only one of the factors upon which this excellent

eco-nomic development is based. The companies in the sector grow

organically and are typically less dependent on external investors.

They important sector delivers constant, sustainable growth for

the Berlin-Brandenburg region.

Relatively strong fluctuation is typical of the still-young

biotech-nology sector. Established companies go and new ones come to

take their place. The high number of start-ups, which ultimately

compensate for failed business ventures, is another reason for

optimism. To ensure the successful development of these young

companies, private investors must actively participate in

ear-ly-stage financing again.

Dr. Karen Uhlmann

COO/Co-CEO Omeicos Therapeutics GmbH

Dr. Robert Fischer

CSO/Co-CEO Omeicos Therapeutics GmbH

OMEICOS Therapeutics is working on a new drug for the treatment of atrial fibrillation, and would like to implement the clinical

devel-opment by the end of 2016. The demand for a new atrial fibrillation treatment is high – and with it, its commercial potential. All of the

medicines available now to the majority of patients have a limited effect, and some of them go hand in hand with highly problematic

side effects. Working with their partners at the Texas Southwestern Medical Center, scientists at the Max Delbrück Center for Molecular

Medicine (MDC) Berlin-Buch have identified a metabolism product of the Omega 3 fatty acid with an anti-arrhythmic effect. Based on

this product, they have synthesized drug candidate OMT-33. The fact that the active ingredient can be further developed for

commer-cial use as part of a start-up is due to the very good general conditions existing before the company was even established. OMEICOS

received its initial financial support from the MDC PreGO-Bio funds and Helmholtz Enterprise, the spin-off support project of the

Helmholtz Association. The company received seed financing through a High-Tech Gründerfonds participation and ProFIt funding

from the state of Berlin, which is co-funded with capital from the European Fund for Regional Development (EFRE). With its BioTech

Park, Campus Berlin-Buch provides the ideal framework conditions and an outstanding infrastructure for our product development

phase. Of course the direct proximity to MDC is essential to our success. OMEICOS and MDC will continue to work in close

partner-ship. And our cooperation with the Campus' BBB Management GmbH also makes the location very attractive for us.

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vfa bio represents the biotech interests within the German Association of

Research-Based Pharmaceutical Companies (vfa). vfa campaigns for the

interests of 45 worldwide leading pharmaceutical companies in the fields

of health, research and economy.

vfa bio seeks to exploit the therapeutic and economic potential of

bio-technology to make Germany the leading biotech location in Europe.

Medical biotechnology is vfa bio’s topic. We primarily deal with:

▪ Medical progress provided by biopharmaceuticals -

benefit for patients, physicians and society as a whole

▪ Access to biopharmaceuticals for patients

▪ Business location Germany and regulatory and economic framework

for research, development and production of biopharmaceutical

▪ Biosimilars

▪ Orphan medicinal products (medicines for rare diseases)

▪ Advanced therapies such as gene and cell therapy and tissue

engineering products

Bild: © vfa / Mar tin Joppen
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BioTOPics 47 | May 2014 BioTOP-Report Biotechnology

But they will only do so if the general conditions for venture capital

are significantly improved. The political decision makers seem to

agree on this objective – now all they have to do is adopt relevant

new laws.

The Start-Up Capital is Booming

For many years, the Berlin-Brandenburg region has been

gener-ating international headlines as the start-up capital of Germany.

Hardly a week goes by without a new start-up being founded, a

major financing round being concluded or a major corporation

committing to act as an accelerator or incubator. The region is

booming; it’s an international hot spot. However, this has more to

do with IT and web-based applications start-ups.

Till Erdmann

Managing Director Myelo Therapeutics GmbH

Dirk Pleimes

Managing Director and Chief Medical Officer Myelo Therapeutics GmbH

We are a young pharmaceutical company that develops new

therapies in fields of application with high medical needs. With

a clear strategy for developing our innovative active ingredient

Myelo001 for treating chemotherapy-induced neutropenia, we

have successfully obtained the support of a series of strategic

investors, including IBB Beteiligungsgesellschaft, Eckert Life

Science Accelerator (ELSA) and Valenta Pharmaceuticals.

The German capital region provides a high concentration of

science and research, clinics and business, as well as a high

quality of life. It is predestined to be a location for

pharma-ceutical companies. The technology parks and networks that

are part of the Healthcare Industries cluster represent an

out-standing infrastructure for translating the latest scientific

find-ings into innovative products.

0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 Agriculture/Food

Market Segments of Companies

White Biotechnology /Environmental Biotechnology Biomedicine

'13 '04 '05 '06 '07 '08 '09 '10 '11 '12 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 Number of companies

31

14%

45

19%

204

88%

Most companies focus on biomedicine. A total of 88 % of companies, focus primarily on development in the areas of new diagnostics, drug development and associated services or technologies. 13 % of the companies are active in the agriculture / food sector, white biotechnology / environmental biotechnology amounts to 19 % of all entries. (Source: Internal survey, BioTOP database, responses from 232 companies, multiple entries, February 2014)

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BIOCOM AG | Lützowstraße 33–36 | 10785 Berlin | Germany www.biocom.de | Tel. +49 (0)30 264921-0 | Fax +49 (0)30 264921-11

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G T T A C T AC G T C C TGC AT G T T G C GA T T G GGA AGA A A A C T C

(12)

12

BioTOPics 47 | May 2014 BioTOP-Report Biotechnology

Does this status relate at all to start-ups in the life sciences? At first

glance, perhaps not. But take a closer look: The large number of

players (founders, investors and incubators), the university

sup-port programs and many start-up competitions, and the range of

various activities create a start-up-compatible atmosphere, which

has a positive impact on the start-up scene in the life sciences.

Putting it simply, the spillover effect is high.

There have not been as many life sciences start-ups in years as

there were in the last half of fiscal year 2013/2014. And the

strik-ing thstrik-ing about them is that some of the new companies are

focus-ing on new drug development. Here are a few examples of recent

start-ups and their concepts:

OMEICOS

Therapeutics

is a spin-off of the Max Delbrück

Cen-ter for Molecular Medicine. It develops synthetic compounds with

innovative modes of action for the treatment of various human

diseases. The company is working on a new drug for the

treat-ment of atrial fibrillation, the most common type of human

car-diac arrhythmia.

Myelo Therapeutics

has developed a drug for

the prophylactic treatment of post-chemotherapy patients whose

blood contains too few white blood cells (neutropenia) or platelets

(thrombocytopenia). Venture capital investors IBB

Beteiligungs-gesellschaft with their VC Fonds Technologie Berlin, Eckert

Wag-niskapital und Frühphasenfinanzierung and JSC Valenta

Phar-maceuticals are in the company’s financing consortium.

Amal

Therapeutics

, a company with facilities in Geneva and Berlin, is

developing a vaccine consisting of a recombinant protein with a

cell-penetrating peptide acting as a vector. The unique property

of this platform is its ability to trigger a highly integrated,

multi-epi-topic cellular immune response to cancer cells.

DexLeChem

, a

TU Berlin spin-off, provides development services to the

chemi-www.takeda.de

For more than 230 years, Takeda has been serving society

with innovative medicines. Now, with new healthcare solutions

from prevention to care and cure, we are determined to help

even more people enjoy their lives to the fullest. Of our 30,000

employees worldwide, 1,700 are working in Germany to

develop, produce and market a broad range of medicines to

help patients reclaim valuable moments of life from illness.

Our Business: Committed to Improving Health

(13)

13

BioTOPics 47 | May 2014 BioTOP-Report Biotechnology

cal-pharmaceutical industries for making production processes

more chiral, meaning to convert substances with spatially complex

designs into water-based processes. The catalyst is not modified

before re-use. With this resource-conserving reaction process

control, customers – drug and fragrance manufacturers – benefit

from more cost-efficient, environmentally friendly production

pro-cesses.

GlycoUniverse

is a technology spin-off of the Max Planck

Institute of Colloids and Interfaces. The company specializes in

the automated development and synthetic production of complex

sugars. With GlycoUniverse’s state-of-the-art oligosaccharide

synthesizer GLYCONEER

®

, the process of synthesizing complex

carbohydrates that formerly took months or years can be

complet-ed in a matter of days or even hours.

The high number of start-ups is the result of a critical mass of

players, activities and initiatives in the start-up area, its

well-developed infrastructure and excellent location factors as

well. These include the seven biotechnology parks that make

affordable laboratories and technical infrastructure available,

and the many scientific institutes that produce highly skilled

specialists. The universities join in with comprehensive spin-off

support programs, some of which are triggered by the federal

government’s “EXIST-Gründungskultur - Die Gründerhochschule”

competition. Pharmaceuticals giant Bayer Healthcare has

also discovered the region’s potential, providing the technical

infrastructure, professional support and expertise of an

established pharmaceuticals company to young companies via

its CoLaborator, opened in May. Another important element is the

many business plan competitions in which founders receive initial

feedback for their business concepts. With 140 events, a network

of over 200 consultants and over 500 business plan submissions

per year, the Berlin-Brandenburg Business Plan Competition is

one of the largest competitions of this type in Germany.

The momentum in the Berlin-Brandenburg region is powerful –

especially at the interface of IT and the life sciences. There are

a variety of names for this new area, including eHealth, itHealth,

dHealth and mHealth. What they all designate is the successful

fu-sion of the two fields, facilitated by web-based applications in the

medical sector. This development is still young, but with its unique

density of IT and life sciences players, the Berlin-Brandenburg

location is particularly suitable for generating new companies.

The first companies have already been founded; take

Caterna

, an

online school for visual exercises, or

NeuroNation

, the new digital

brain-jogging platform for example. There are many new

compa-nies in this new field, and in XL Health, it even has a financially

strong investor specialized in digital health.

Financing and Added Value

VC Fonds Technologie Berlin was set up as a joint initiative of Investitionsbank Berlin (IBB) and the State of Berlin. It is co-financed by the European Regional Development Fund (ERDF).

Venture Capital

for companies in Berlin

IBB Beteiligungsgesellschaft mbH offers equity

financ-ing for high tech companies in Berlin. For our fund

VC Fonds

Technologie

Berlin

(

52m) we are looking

for investment opportunities in the biotechnology and

medical technology sector.

Our investment approach is based on hands-on

invol-vement and active management support for each

portfolio company, delivered by our highly

expe-rienced investment team.

VC Fonds

Technologie

Berlin

not only provides capital, but also helps execute the

business plan.

Are you interested? Please do not hesitate to contact us.

IBB Beteiligungsgesellschaft mbH

Mrs. Ute Mercker / Mr. Christian Seegers

Bundesallee 210

10719 Berlin / Germany

Phone: +49 (0)30 2125-3201

www.ibb-bet.de

(14)

BioTOPics 47 | May 2014 BioTOP-Report Pharma

Pharma

Attractive Location

The capital region has developed into one of Germany’s most important, attractive centers for the medical and

healthcare industries. Based on the significant growth of the pharmaceuticals industry in Berlin, these sectors are

the growth engine of the regional industry. Currently, the sectors employ approx. 10,000 people in the German

capital region. This means that pharmaceuticals companies account for around one in every 10 jobs in the regional

industry – and every 11th employee in the pharmaceuticals sector in German works in Berlin.

Globally active corporations are located along the Spree River:

Bayer Healthcare, Berlin-Chemie, Pfizer Deutschland, Sanofi

Deutschland and since 2011, Takeda. The capital region is also

home to over 20 medium-sized pharmaceuticals companies,

in-cluding several world market leaders.

Above all, the sectors benefit from the capital region’s excellent

scientific environment and clinical research landscape, the

prox-imity to decision-makers in the healthcare system and the ready

availability of well-educated skilled specialists. A steadily growing

number of global players and medium-sized companies are

set-ting up business here or moving their corporate headquarters to

Berlin and the capital region, to take advantage of these location

assets. With over 220 companies, Berlin is also a leading global

location in the biotechnology sector and the pharmaceuticals

in-dustry has created a close, innovative network with these partners.

The Berlin-Brandenburg region has an outstanding position in

sev-eral sectors that the experts certify as having a strong growth

outlook due to their excellence in innovation.

The pharmaceuticals sector's innovative excellence pays doubly

for Berlin-Brandenburg, which is also one of the country's

lead-ing research locations. The partnership between pharmaceuticals

companies, clinics and hospitals and scientific institutions

guar-antees ultra modern patient healthcare of a uniquely high quality,

and the innovations of the pharmaceuticals companies are

creat-ing and securcreat-ing the jobs of the future for the region.

The current investment and activities of the local

pharmaceuti-cals sector are proof of Berlin's appeal and bear witness to the

companies' commitment to the capital region.

Bayer

has paid

billions to conclude the takeover of Norwegian cancer treatment

specialists Algeta. Bayer made the move to strengthen its position

in the tumor medication area. The company is also increasing its

commitment to young, innovative technology companies. In May

2014, it launched the CoLaborator incubator program. An

incu-bator model for biotechnology start-ups, CoLaborator was tested

in San Francisco (Mission Bay) two years ago. In the specially

equipped research building, up to 10 innovative biotechnology

companies can now get to work – thanks to Bayer.

Within the next two years,

Berlin-Chemie

will invest €40 million in

the expansion of its location, continuing to develop its position as

one of the sector's leading employers.

In Berlin, we find an excellent scientific and commercial

envi-ronment. This is an important basis for further investments and

the expansion of our location in the south-east of the city. In

addition required extensions are planned, among others a new

building for the quality control, a new staff canteen, an

exten-sion of the office capacity for the administrative area and the

resulting infrastructural measures in the form of new roads,

paths and parking facilities for our employees.

Dr. Rainer Uppenkamp

(15)

Innovation for better health.

Our commitment

is to bring to patients around the world quality

medicines for use in diag nosing, combating and

preventing disease. Every day we work against time,

researching new pathways, new molecules, new

technologies – complementing our own capabilities

with exper tise of innovative partners from science

and industry.

The success of this work is evidenced in new

med­i­cines­for­areas­with­significant­unmet­medical­

need such as oncology, cardiovascular and blood

diseases, as well as gynecology and ophthalmology.

Our aim is a better quality of life for all.

You need commitment, focus and

passion to find new ways to fight the

diseases of this world: innovation

is at the heart of it.

www.bayerhealthcare.com

www.bayerpharma.com

(16)

BioTOPics 47 | May 2014 BioTOP-Report Pharma

The partnership between

Sanofi

and Charité that began in May

2010 with a focus on the area of stroke research has proven

fruit-ful. The partners have signed an agreement to a second joint

research partnership, this time with a focus on diabetes. The

scientists and clinicians of both parties will also collaborate in a

diabetes alliance in the future. The alliance aims to improve

un-derstanding of the medical requirements and approaches to the

disease of diabetes and, in joint projects, to implement them as

therapies and make them available to patients more quickly.

After the acquisition of Nycomed in 2011,

Takeda

moved its

Ger-man headquarters to Berlin and took over the Oranienburg-based

production plant. Oranienburg has a long tradition as a location for

pharmaceuticals production. In the past 20 years, the plant there

has expanded continuously. It now has a production capacity of

7.6 billion pills and capsules per year – 98 percent of which are

exported worldwide. The Oranienburg facility is considered one

of the main competence centers within Takeda's global

produc-tion network. Takeda plans to expand the Oranienburg facility's

production capacity within the next few years.

An important new player,

Teva Specialty Medicines

, has recently

set up business in Berlin. Newly founded Teva Specialty

Medi-cines is Teva Pharmaceuticals' Original Products division in Berlin.

Its primary area of success is neurology. Teva is the leader in

generics in Germany and an expert in innovative brand business.

At a January 2014 press conference in Berlin,

Aristo Pharma

pre-sented a new formulation of a proven drug for treating severe and

extreme pain. The special formlulation was designed for targeted

retardation and 24-hour continuous analgesia when taken once a

day. Founded in 2008, the company belongs to a growing group

of German companies headquartered in Berlin.

DR. KADE

acquired Takeda’s OTC business for the German

mar-ket in April 2013. With this move, the traditional Berlin company

has added well-known brands to its current OTC portfolio and

made an investment in the future. In conjunction with the

expan-sion of its OTC business, the company has added new employees

in its Berlin and Constance locations.

PharmaMar

is a Spanish member of the Zeltia Group, a leader in

the development of anti-tumor drugs of marine origin. PharmaMar

started its activities in Germany in 2007, when the EMA granted

it marketing authorization for Yondelis

®

in the treatment of soft

tis-sue sarcomas. Two years later, Yondelis

®

was approved for the

treatment of ovarian cancer. In 2013, the company established

PharmaMar GmbH in Berlin.

These current examples are only an indication of the

pharmaceu-ticals industry activity in Berlin-Brandenburg – but they illustrate

the extent to which the opportunities here are multi-faceted. They

range from close partnerships with regional biotechnology

start-ups and partnerships with science to location expansion and

inward investment. The range of opportunities and the strategic

options they generate make the Berlin-Brandenburg region highly

attractive.

Dr. Hans-Christian Meyer

Site Manager

Takeda Plant Oranienburg

Pharmaceutical development and production has a long

tradi-tion in the area of Berlin-Brandenburg. The roots of our

pro-duction plant in Oranienburg trace back to the 19th century.

Today, our site plays a pivotal role as a competence center for

solid forms such as tablets and capsules within the worldwide

pharmaceutical production network of Takeda. The support

of the Investitionsbank des Landes Brandenburg helps us to

further expand production capabilities, be prepared for future

growth and create new jobs.

Alfonso Casal

CEO

PharmaMar GmbH

Our presence in Germany, the European State Member with

the largest population in the EU and strong research

capa-bilities is an important step in our European expansion. From

our offices in Berlin we coordinate our commercial operations

as well as supporting other corporate activities in Germany.

Berlin as Capital city, with important competence centers for

the treatment of cancer and strong international orientation

represents a very good opportunity for the development of our

activities.

(17)

For more information:

BERLIN-CHEMIE AG · Glienicker Weg 125 · 12489 Berlin

Phone: +49

30

6707-0 · www.berlin-chemie.de

Modern research, development and manufacturing

of innovative medicines in Berlin-Adlershof – this is

what BERLIN-CHEMIE stands for. Research and

production are based not only on our experience of

over one hundred years but also on our successful

search for new therapeutic pathways and

possibili-ties. The success we have gained around the world

and the growth of BERLIN-CHEMIE are an

endorse-ment of our high standards.

(18)

BioTOPics 47 | May 2014 BioTOP-Report Glycoscience

Glycoscience

Glyco Research for Innovations in Health Industry

Alongside genome and proteome research, the study of sugars glycoscience, is increasingly gaining importance.

As our knowledge about the function of sugar structures in a variety of biological processes grows, the areas of

application for glycoscience are also growing and affecting other fields in the Healthcare Industries cluster such as

diagnostics, drug development, regenerative medicine and industrial biotechnology. Sugars can develop complex

structures, glycans, and can be even bound to proteins – in which case they are called glycoproteins. Glycans

are important for a wide variety of biological processes. They control cell-cell communication and the function and

stability of proteins, and play an important role in the immune response. Carbohydrate metabolism malfunctions

are typically associated with neurodegenerative diseases, infections and cancer.

Exploiting high potential for interdisciplinary

technologies

Glycan structures, as molecules expressed due to illness, can

be used as significant diagnostic parameters and can serve as

differentiation markers for regenerative medicine. Glycan-based

molecules can also be used as vaccines e.g. for malaria and HIV.

Glycoscience also contributes to the development of drugs,

in-novative foods and human-compatible biomaterials. When

con-sidering the diverse application fields of glycoscience, it is

ap-parent that the capital region occupies an outstanding position.

Berlin-Brandenburg is a technology leader in the chemical

syn-thesis of glycans, and in glycan analytics it offers

international-ly significant expertise. We also provide excellent conditions for

applications in the fields with high cross-innovation potential. The

region is a leading international location for research and

devel-opment in diagnostics and the implementation of clinical studies

and also has highly productive drug and nutrition research. With

the university hospital Charité Universitätsmedizin Berlin globally

acknowledged medical expertise is also present in the region.

Establishing a glyco hub in the capital region

Research, whether university-related, independent or clinical,

forms the outstanding scientific basis of the region. The Charité

has been honing its expertise in the fields of glycoanalytics and

glycodesign for many years. The director of the Max Planck

In-stitute of Colloids and Interfaces in Potsdam (MPIKG) and

inter-nationally renowned glycoscientist Professor Peter Seeberger

discovered and developed the total synthesis of complex

carbo-hydrates. GlykoUniverse, a spin-off company, will distribute the

completely automated carbohydrate synthesizer. There are other

excellent companies in the region as well. Located in Berlin,

Scie-nion GmbH is distinguished in the field of glycan microarray

tech-nology for molecular diagnostics. Glycotope GmbH is specialized

in optimizing sugar structures of glycoproteins and developing

therapeutic antibodies for cancer cells. In the wake of a strong

growth period in recent years and the acquisition of €55 million

in venture capital, Glycotope now has over 180 employees and

is a world leader in glycobiotechnology. The objective is to turn

Berlin-Brandenburg into a leading international center for

glyco-science research and translation for the development of

diagnos-tic and pharmaceudiagnos-tical products, cell-based therapies and new

materials for medical applications by employing an expansion

strategy. We will also be working to intensify the technology

trans-fer based on regional networks and stabilize the communication

between science and industry.

GlycanForum, the international conference that takes place in

Ber-lin every year, presents the current status and outlook for

glycosci-ence in biomedicine. It is organized with the support of the Center

for Molecular Diagnostics and Bioanalysis (ZMDB) and BioTOP

Berlin-Brandenburg. The most important conference in the world

with regard to glycoscience, GlycanForum is an outstanding open

exchange platform for business, industry and users. With a

sub-theme of "The leading scientists of Asia," the 7th conference in

2013 was focused on the topics of healthcare, material science,

analytics and synthesis.

Dr. Véronique Blanchard

Head of Glycoanalytics working group at the Institute of Laboratory Medicine, Clinical Chemistry and Pathobiochemistry, Charité – Universitätsmedizin Berlin

As a location for glycoscience, the capital region is unique in

Europe. You find the entire spectrum here, from basic research

to manufacturing industry, which creates the ideal conditions

for efficiently translating research innovations to industry and

clinics. At Charité, we are researching the potential of

glycan-based biomarkers in tumor diagnostics and in bioanalytics for

the quality assurance of stem cell preparation, and developing

a glycan microarray platform for diagnostics.

With more than 15 years of experience, Portus

Corporate Finance supports technology focused

companies in all areas of financing. We base our work

on solid know-how, years of experience and reliable

business partners.

If you are looking for advise and support in the

areas of

• Company and Project Funding

• Company Succession / M&A

• Finance Management / CFO-Services

• Consulting and Coaching

• Establishment of Businesses

please don‘t hesitate to contact us!

Corporate Finance Consulting for Life Science Companies

www.PortusCo.com

Portus Corporate Finance GmbH

Friedrichstr. 81

D-10117 Berlin

Tel

(030) 700 800 900

Fax

(030) 700 800 901

Email info@PortusCo.com

(19)

With more than 15 years of experience, Portus

Corporate Finance supports technology focused

companies in all areas of financing. We base our work

on solid know-how, years of experience and reliable

business partners.

If you are looking for advise and support in the

areas of

• Company and Project Funding

• Company Succession / M&A

• Finance Management / CFO-Services

• Consulting and Coaching

• Establishment of Businesses

please don‘t hesitate to contact us!

Corporate Finance Consulting for Life Science Companies

www.PortusCo.com

Portus Corporate Finance GmbH

Friedrichstr. 81

D-10117 Berlin

Tel

(030) 700 800 900

Fax

(030) 700 800 901

Email info@PortusCo.com

We have offices in Berlin/Bremen/Cologne/Frankfurt/Hamburg/Munich/Stuttgart

For further information please contact Dr. Ulla Peters

UHY Deutschland AG · Wirtschaftsprüfungsgesellschaft · Zimmerstraße 23 · 10969 Berlin

Phone +49 30 226593-0 · Fax +49 30 22679050 · www.uhy-deutschland.de · www.uhy.com

UHY Deutschland AG is a joint venture of long established

auditing and consulting firms with a total of 250 employees

and partners.

As a member of UHY International, a global association of

independent accounting and consulting firms with over

7,600 employees, we can provide audit, accounting, tax

and consulting services in 275 business centres across the

globe.

UHY Deutschland AG has extensive experience in financial

and consulting services for life sciences companies for

many years.

We offer the following services:

• Audits of financial and consolidated statements

under the German Commercial Code (HGB) and IFRS

• Accounting & Reporting

• Due diligence (financial and tax) and business valuations

• Consulting services on IPOs

• Business Advisory

• Mergers & Acquisitions (M&A)

• German and international taxation

(20)

BioTOPics 47 | May 2014 BioTOP-Report Bioelectronics

Bioelectronics

The Joint Lab Bioelectronics –

A New Platform for the Integration of

Microelectronics into Life Sciences

The introduction of new experimental techniques causes a major advantage in the field of biology. Well-known

examples are the invention of optical and electron microscopy, without which the fundamental structures of life as

cells and cell organelles could not have been discovered. The next paradigm shift may very well be triggered by

applying microelectronics – and its developing field of bioelectronics – at its interdisciplinary interface with the life

sciences.

This positive outlook is mainly a result of the phenomenon called

“scaling” in microelectronics: for the last few decades, minimum

feature dimensions have continuously become smaller by a

fac-tor of around two every second year. At first glance, this seems

to be a minor development relating to an uninteresting technical

parameter, since we have become accustomed to working with

increasingly powerful computers and to storing higher and higher

data volumes on a single flash memory. For the life sciences,

how-ever, scaling is a major advance. It has taken microelectronics or

more accurately, nanoelectronics, to the same structural levels at

which the molecular mechanisms of life operate.

Particularly interesting perspectives arise for biosensorics, in

which semiconductor preparation technology can be applied to

the fabrication of cost-effective diagnostic systems.

Bioelectron-ics is also significant for the process analytical techniques (PAT)

for monitoring, regulating and increasing the efficiency of

biopro-cesses. The Berlin-Brandenburg region is eager to take

advan-tage of this development and therefore, IHP in Frankfurt (Oder)

and the TU Berlin Institute of Biotechnology have founded Joint

Lab Bioelectronics. This step will intensify the interdisciplinary

ex-change between the two disciplines and expand biotechnology

students’ knowledge of the basics of microelectronics.

JANUARY 2013

Charité and FU are jointly successful in the competition "EXIST-Gründungskultur – Die Gründerhochschule" of the German Federal Ministry of Economics and Technology +++ German Research Foundation extends collaborative research centre (SBF 650) at Charité – ten million Euros for research on immunological therapy

FEBRUARY 2013

Humboldt research award gets Ivy-League professor Klaas van Wijk to Potsdam

+++ Biopolymers – strong future field with high potential for innovation presents itself in Schorfheide

MARCH 2013

Hasso-Plattner-Institut speeds up personalised medicine with new data bank technology +++ Integrative Research Institute for Life Sciences (IRI) founded in Berlin +++ Paul Ehrlich- and Ludwig Darmstaedter Prize goes to MDC scientist Dr. James Poulet

APRIL 2013

Charité and Sorbonne found Virchow-Villermé Centre for Public Health +++ EU-OPENSCREEN included in the new BMBF-roadmap for large research infrastruc-tures

MAY 2013

New laboratory building of MDC opened – named after physiologist Max Rubner

+++ Stem cell researchers in Germany pool their expertise. They found the Ger-man Stem Cell Network (GSCN) on May 7th 2013 +++ Evaluators praise Berlin

Institute of Health (BIH). Enst Theodor Rietschel becomes chairman

JUNE 13

BIH officially opened +++ Charité – Universitätsmedizin Berlin once more reach-es rank 1 of Focus-ranking "Germany's breach-est hospital"

JULY 2013

Prof. Angelika Eggert receives Einstein professorship and takes over as head of the Children's Clinic with focal areas of oncology and hematology +++ Scien-tists from the A*STAR Genome Institute Singapore and the Max Planck Institute for Molecular Genetics (MPIMG) in Berlin decode the communication network in human embryonic stem cells +++ Scientists from Charité and the MDC, working in cooperation with colleagues in Kiel, Boston, Zurich and London, discover a new gene for hereditary heart failure +++ Scientists working with Peter Seeberger (MPIKG) in Potsdam-Golm have developed a simple, cheap and reliable test for Yersinia pestis, the bacteria that caused the plague

AUGUST 2013

1000th protein structure decoded at BESSY II +++ The World Health Summit 2013 in Berlin in August 2013 discussed solutions for global healthcare with regard to “Research and Innovation.” +++ BPI and vfa present national plans of action for

the quick diagnosis and more effective treatment of rare diseases

SEPTEMBER 2013

Scientists at Charité and MDC discover sugar withdrawal as an innovative cancer therapy approach +++ Technische Universität Berlin and Leibniz Institute IHP Frankfurt (Oder) have established Joint Lab Bioelectronics, a laboratory for joint interdisciplinary research +++ Charité and Harvard sign a cooperation agree-ment aimed at accelerating clinical translation, primarily in the cell and tissue technology field +++ Prof. Annette Grüters-Kieslich, Charité Dean, receives the

Prof. Dr. Peter Neubauer

Technische Universität Berlin Institute for Biotechnology Chair for Bioprocess Engineering

The Joint Lab Bioelectronics aims to advance the field of

Bio-Process Analytical Technologies by connecting sensor

spe-cialists and bioengineers.

(21)

21

BioTOPics 47 | May 2014 BioTOP-Report Bioelectronics

The Leibniz Institute IHP – Innovations for High Performance

Micro

electronics – in Frankfurt (Oder) is part of the Leibniz

Association and has a long tradition in the area of silicon-based

microelectronics. The IHP has a clean room at its disposal for the

pilot serial production of 200-mm Si wafers in which microchips

are processed at the 0.25 and 0.13 µm structure levels. A family of

SiGe: C-based hetero bipolar transistors for realizing frequencies

in the low 100 GHz range is the core of IHP technology. As part

of IHP’s multi-project wafer services, external customers may use

the technology for the fabrication of application-specific

integrat-ed circuits.

The TU Bioprocess Engineering chair conducts research on the

characterization of industrial-scale bioprocesses and methods for

consistent, faster bioprocess development. The chair runs a

bio-process pilot plant with advanced analytical instruments, on-line

instrumentation and an analytical laboratory for comprehensive

metabolomics analysis. Its key instruments are proprietary,

scale-down two- and three-compartment bioreactors, which enable the

simulation of large-scale industrial processes in the lab. The

char-acterization of biogas plants, brewery reactors and reactors in

industrial biotechnology with new PAT and model-based process

control for improving their robustness are a major focus. For this

highest honor offered by ESPE, the European Society for Paediatric Endocrinol-ogy: the Andrea Prader Award +++ New Helmholtz post-graduate school for researching biomaterials opens

OCTOBER 2013

Fraunhofer researchers receive an international award for ArtCornea®, their

artificial cornea +++ The capital has healthcare in focus: Berlin Health Week celebrates its launch +++ Sanofi endows two new professorships in the public health field at Centre Virchow-Villermé, the newly established German-French research institute, in its Berlin and Paris locations +++ Charité opens the inten-sive care station of the future

NOVEMBER 2013

NeuroProAllianz receives Technical University of Applied Sciences Wildau research award Dr. Jean-Yves +++ K. Tano from the University of Toledo arrives in Berlin after receiving an Alexander von Humboldt fellowship +++ Charité coordinates the national network of biobanks +++ Immunologist Prof. Klaus Rajewsky from MDC Berlin awarded the Society for Signal Transduction medal of honor

DECEMBER 2013

Charité opens pioneering robotics operating room +++ Scientists from Charité present new approaches toward improving breast cancer therapy as part of the RESPONSIFY EU research project

JANUARY 2014

Under the leadership of Cornelia Weikert from the German Institute of Human Nutrition (DIfE), a team of scientists has discovered a new biomarker for heart

failure in the general population +++ Researchers at MDC Berlin have acquired new knowledge of the body's regulation of insulin production for insulin resis-tance, the root of type 2 diabetes +++ The biochemist and protein crystallogra-pher Prof. Oliver Daumke from MDC Berlin-Buch receives European Research Council funding worth millions +++ BTU Cottbus-Senftenberg strengthens bio-materials research network with Helmholtz Center Geesthacht in Teltow

FEBRUARY 2014

MPIKGPotsdam director Prof. Peter Seeberger and the director of the NII in New Dehli, India agree to intensify their partnership for researching infec-tious diseases +++ Researchers at MDC decipher the creation of new forms of hereditary Alzheimer’s disease and discover new protective mechanisms

+++ Researchers at the Max Planck Institute for Moldcular Plant Physiology in Potsdam-Golm discover new adapter proteins for the reception of substances in plant cellss +++ The Berlin Institute of Health (BIG) acquires Thomas Südhof, Noble Prize for medicine co-awardee, as visiting fellow

MARCH 2014

Two dozen Fraunhofer Society institutes establish the Big Data Alliance +++

MDC receives 3-Tesla MRI scanner for the largest long-term German popula-tion study +++ MDC researchers discover the molecular switch for epilepsy

APRIL 2014

Berlin Institute for Health Research launches first research projects +++ Hans-Hilger Ropers awarded with the “EURORDIS Scientific Award 2014” for his research on rare diseases

PD Dr. Mario Birkholz

Head of Joint Lab Bioelectronics IHP GmbH

Leibniz-Institut für innovative Mikroelektronik

By establishing the IHP and TUB Joint Lab Bioelectronics, we

have created the opportunity for a successful interdisciplinary

partnership. Through it, we will be able to translate the

prog-ress made in microelectronics directly into biotechnological

applications and university education.

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BioTOPics 47 | May 2014 BioTOP-Report Bioelectronics

purpose, new lance- and rope-based mobile sensor and

sam-pling systems that can be directly applied to analyze

concentra-tion gradients have been developed.

A robot-based mini pilot plant has also been established for

pro-cess development in micro-plate and mini-bioreactor cultures.

This highly automated facility focuses on processes with

genet-ically engineered microorganisms. Extensive analyses are

au-tomatically performed on tens to hundreds of cultivations in μl

and ml formats. The laboratory pioneered the EnBase

®

controlled

substrate delivery technology, which is instrumental for consistent

bioprocess development and a key element in this

high-through-put (HT) automated industrial reference laboratory.

Joint Lab Bioelectronics’ mission is to introduce new biosensor

technologies. This work focuses on the adaption of the sensor

system to the particular biotech application. The starting point is

the sensor chips developed at IHP, including a fully embedded

microelectromechanical system (MEMS) for affinity assays and a

cell sensor operated via impedance spectroscopy (see Fig. 1).

However, the biochips fabricated in semiconductor fabs require

special packaging before being introduced into bioprocesses

with an emphasis on hermiticity and must be shielded against

corrosion from the liquid bio milieu.

The demand for microsensors for applications in microfluidic

platforms has jumped in recent years. Many applications rely on

polymer devices, because most companies and scientific

work-ing groups have almost no access to microelectronic fabrication

techniques. Joint Lab Bioelectronics follows the approach of

de-veloping and supplying biotechnological platform modules that

combine equal shares of microelectronic and microfluidic

com-ponents.

Bioprocess engineering is one promising field of application for

miniaturized sensors. Industrial bioprocess development faces

the challenge of reducing the risks, costs and timeframe of new

product launch. In the pharmaceuticals industry in particular, the

regulatory authorities expect dossiers to be based on knowledge

that derives from careful sensing (PAT). Consequently, future

bi-oprocess development will consist of HT technologies based on

miniaturizing, parallelization, automation and intense monitoring.

Joint Lab Bioelectronics is a perfect match for the Bioprocess

Engineering chair’s HT lab, where platform technologies are

de-veloped to comply with the above-mentioned needs. This lab is

Figure 1. Affinity-viscosimetric microsensor chip with fully embedded

MEMS (X-shaped beams on the left) und calibration curves for glucose concentration measurements it has taken, Birkholz et al., J. Appl. Phys. 113 (2013) 24

References

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