Business Profiles - BioValley Deutschland eV

DEUTSCHLAND e.V.
BIOVALLEY COMPANIES DAY 2011
Business Profiles
Sponsored by:
www.biovalley.com
Table of Contents
in order of appearance...
VivaCell Biotechnology GmbH
4
Thierry Briand Consulting
4
ATG: biosynthetics GmbH
5
Bureco AG
5
Logopharm GmbH
6
BIA Separations GesmbH
6
SGS M-Scan GmbH
6
Parexel International AG
7
Fraunhofer Institute for Physical Measurement Techniques IPM
7
Laboratoire Altergen
8
Ernst & Young GmbH
8
Dr. Fenning BioMed GmbH
8
aprentas
9
Analytical Services Dr. Ralph Nussbaum
9
Oncotest GmbH
9
anterio consult & research GmbH
10
Eurofins GeneScan GmbH
10
CONFARMA France SARL
11
ProQinase GmbH
11
EUCRAF Ltd.
12
ChemCon GmbH
12
BGA Group GmbH
13
CellGenix GmbH
13
Swiss BioAnalytics AG
14
Zimmer Germany GmbH
14
IEMS
15
Co-Sponsored by:
Dear attendees,
besides the regulars’ table, the CEO meetings and the LifeScience Day, the BioValley
Companies Day is a fundamental building block of the vision to unite the Upper
Rhine Area, reaching from Karlsruhe, Germany, to Basel, Switzerland, into one
BioRegion.
All of the region’s major organizations participate: the three big universities of Basel,
Strassbourg and Freiburg, the universities of applied sciences, the companies in
the life science industry, service providers and public authorities, such as business
developers and schools.
Our goal is to network the enormous potential of this region. The BioValley
Companies Day offers an excellent opportunity for this purpose. Different companies
are presenting their expertise to an interested audience. The BioValley Companies Day
is the perfect event to get in touch with other companies or institutions, and past
experience has shown that such networking platform meetings are the place of birth
of pathbreaking ideas for the future. Sometimes One plus One equals more than Two.
From the evolutionary point of view, it has always been the biotope which survived,
not the strength of the individual. With this in mind, I wish the BioValley Companies
Day, which is one of the fundamental elements of the BioValley Vision, a lot of
success.
Dr. Steve Fenning, President BioValley Deutschland e.V.
3
VivaCell Biotechnology GmbH
Vivacell Biotechnology GmbH is a privately owned contract-based research organisation (CRO)
that provides specialised in vitro and in vivo models for testing and developing pharmaceutical,
nutraceutical and phytopharmaceutical compounds or extracts.
Contact Person:
Dr. Kurt Appel
VivaCell’s preclinical services include standard protocols and protocols adapted to the needs of
the customers using a variety of in vitro and in vivo systems.
Adress:
Ferdinand-Porsche Str. 5,
D-79211 Denzlingen
VivaCell Ltd. is combining highly qualified cellular and molecular biology knowledge and expertise
in various fields with a focus on immunology, CNS, oral care, nutraceuticals and natural products.
Phone:
+49 (0) 7666 902877
info@vivacell.de
www.vivacell.de
At VivaCell Ltd., we offer you complete research projects from basic R&D up to pre-clinical
research (GLP) in one hand. Our clients do not have to gather the research data from various CROs.
We have demonstrated our expertise in a variety of research projects and scientific publications.
We offer services for a large variety of indications:
•• Immunomodulation: inflammation, common cold, arthritis etc.
•• Viral entry/inhibition of neuraminidase (anti-viral)
•• Oral care/Dental care
•• Central Nervous System: Stroke, mood, anxiety, depression etc.
•• Dermatology/Cosmetics/Hair
•• Urinary: benign prostatic hyperplasia etc.
•• Diabetes
•• Oncology / Angiogenesis
•• Muscle
•• ADME (e.g. drug interaction, permeability studies)
•• Toxicology (e.g. genotoxicity, irritation)
•• Animal health/nutrition (pets/horses)
Thierry Briand Consulting
Thierry Briand Consulting offers technical due diligences for biopharmaceutical companies.
Contact Person:
Dr. Thierry Briand
Adress:
9 rue de l’Etoile,
F-68330, Huningue
Phone:
+ 33 3 89 67 98 84
Thierry.F.Briand@orange.fr
www.ThierryBriand.com
Scope of services:
Authenticity and compliance check of data
State-of-the-art analysis and comparison with competitors’ development
Review of business and development plans
Milestones assessments of achievements
Independent assessment of achievements
Prepare rehearsals, dry runs, and data rooms
Lead and coach due diligence teams
Clients:
Biotech and biopharmaceutical companies
Institutional investors (private equity, venture capitalists, etc.)
High net worth individuals (HNWI), business angels, institutions
Types of companies audited:
From semi-virtual SMEs to major international biopharmaceutical companies
Audited Structures: Holdings, companies, portfolios, therapeutic areas, programmes and projects
Audited Entities: Conventional chemical entities
Biologics
Delivery systems and devices
Stages:
From late-research throughout development, commercialization,
and post-marketing
Types of audits:
Before in-licensing, or out-licensing
Milestone reviews, or ad-hoc special focuses
Parts of the audit that are not performed:
Expert analysis of Intellectual Property
Financial or legal analysis
Pure research projects
Academic expertise
Audit Contents:
4
Technical, scientific and regulatory cross-functional detailed assessment of the assets, opportunities, risks, capabilities and skills of the company‘s management teams. In addition, the adequacies of the business plans versus resources and time lines needed to implement the strategies are analyzed.
ATG:biosynthetics GmbH
“Artificial and Technical Genomics”: this is what ATG is about. The company has been active in
the field of biotechnology and synthetic biology since 2001.
ATG is a bio-engineering consultant for planning, operation and controlling of synthetic
biotechnology projects, e.g. in drug discovery for biologics, molecular diagnostics and
bioproducts for pharmaceutical and medical industries as well as applications in the field of white
biotechnology.
Incorporation and development of new technologies to drive integrated synthetic biotech projects.
Product and service portfolio:
•• Synthetic Genes / Gene Synthesis
Contact Persons:
Dr. Hubert Bernauer
Alexander Craig
Adress:
Weberstraße 40,
D- 79249 Merzhausen
Phone:
+49 (0) 761 888 94 24
info@atg-biosynthetics.de
www.atg-biosynthetics.com
•• (Artificial) Pathway Design and Gene Cluster Assembly for all Applications in Synthetic Biotechnology
•• Bioinformatics services, e.g. proprietary top-notch evoMAG software for optimization of genes and gene expression
•• ACEMBL multi-protein recombineering co-expression system (standard - E.coli, insect and mammalian cells; custom systems on demand)
•• Expression cassette modelling for E.coli, insect cells but also other production organisms (yeasts, mammalian cells, etc.)
•• bioPeptide libraries (PepID) for epitope mapping, antibody testing, etc.
•• ACEMBL + PepID: in vivo protein-protein-interaction analyses for drug discovery and target identification and validation
•• Functional enzyme optimization
ATG is member of the International Association of Synthetic Biology (IASB).
BURECO AG
BURCO AG is a GMP and GLP certified bioanalytical service organization serving the Life Science
Industry worldwide, offering immunological, cell based, biochemical, and radiometric technologies. Our services are mainly focussed on biopharmaceuticals linked to pre-clinical and clinical
development.
Many years of experience in assay development and optimization, assay transfer, assay implementation, assay validation and testing of pre-clinical and clinical samples as well as drug substance
and drug product samples, makes us a reliable partner:
•• Biomarker/biopharmaceuticals determination in animal and human samples (GLP)
•• Immunogenicity/Neutralizing Antibodies/Anti-Drug Antibodies (GLP)
•• Potency Bioassays (Release and Stability Testing) (GMP)
Contact Person:
Dr. Bernhard Schnurr
Adress:
Kägenstrasse 17,
CH-4153 Reinach
Phone:
+41 61 487 9500
Bernhard.schnurr@bureco.com
www.bureco.com
•• Endotoxin (LAL) and Monocyte Activation Test (MAT) (GMP)
•• Cytotoxicity
•• Consulting in assay development/validation and selecting strategies
BURECO AG is known as a reliable partner delivering data of outstanding quality and adherence to
timelines. This is proven by long-term relationships with clients worldwide. BURECO AG permanently evaluates and implements new technologies in order to meet customer’s expectations and
the market needs.
5
Logopharm GmbH
Contact Person:
Dr. Uwe Schulte
Adress:
Schlossstr. 14,
D- 79232 March-Buchheim
Phone:
+49 (0) 761 20 35 127
u.schulte@logopharm.com
www.logopharm.com
LOGOPHARM GmbH is a biotech company that provides specialized services in proteomic target
and biomarker R&D with independent discovery projects for CNS indications.
The company located at Freiburg (Germany) was founded by a team of scientists and business
experts. It combines proprietary proteomic technologies, long-term experience in functional
membrane protein analysis and innovative drug development concepts with focus on membrane
proteins and protein complexes. Our proprietary developments include the CompleXio technology
for identification of protein-protein interactions in native tissue, microproteomic analysis with
ultimate sensitivity and label-free quantitative mass spectrometry. The used strategies are broadly
applicable to targets and biomarkers, require very small amounts of sample and show a lower error
rate than current high-throughput approaches.
Based on this we offer advanced proteomic services, research consulting and implementation
of technology, individually adapted to our customers’ needs. In addition, we have established
research collaborations with distinguished academic and commercial partners to promote our
technology and independent development projects.
BIA Separations GesmbH
Contact Persons:
Tobias Bächle
Production of methacrylate monolithic material with 1,5um pore size for separation/purification
of large molecules like Proteins, Viruses, Phages and Endotoxinremovement. Separation from
analytical to industrial scale within several minutes with low backpressure, chromatography redesigned.
Adress:
Europastrasse 8 ,
CH-9524 Villach
Phone:
+49 (0) 171 274 3139
www.biaseparations.com
SGS M-Scan GmbH
Contact Person:
Dr. Pascale Seiter
Office Bonn
Triererstrasse 70-72
D- 53115 Bonn
phone: +49 (0) 228 85 09 145
services.de@m-scan.com
Adress:
Engesserstrasse 4A
D- 79108 Freiburg i.Br.
Phone:
+49 (0) 761 611 677 60
services.de@m-scan.com
www.m-scan.com
6
SGS M-Scan, the world leaders in the application of advanced mass spectrometry techniques for
protein and carbohydrate structural analysis, comprises of four laboratories in Europe and the US.
The German Laboratory SGS M-Scan GmbH is based in the “Biotech Park” Freiburg.
The SGS M-Scan laboratories provide GLP/GMP compliant analyses for bio/pharmaceuticals, from
small molecules/NME’s through to peptides, proteins and glycoproteins such as monoclonal
antibodies, including biosimilar products at all stages of the product development pipeline.
Analyses range from pharmacokinetics, metabolism, impurity analysis, de-novo sequence
determination, to full characterisation to appropriate FDA/ICH guidelines (ICH Q6B), with
particular emphasis on post-translational modifications.
SGS M-Scan laboratories are equipped with a range of some 25 high performance mass
spectrometers and are complemented by gas-phase sequencing, HPLC, CD, SEC-MALS, AUC, 2-AB
labeling analysis and amino acid analysis.
In November 2010, M-Scan became part of the SGS Life Sciences Services group. SGS Life Science
Services is the largest network of contract analytical laboratories with 17 facilities in 11 countries.
The group provides clinical research services, analytical development, biologics characterization,
quality control testing, microbiology and stability studies and extractables and leachables tests
that meet regulatory requirements to biotechnology and medical device manufacturers.
Parexel International AG
PAREXEL International, a leading global biopharmaceutical services organization, has been a
proven, committed partner to pharmaceutical, biotechnology and medical device companies for
the past 28 years.
Together with our customers, we have combined our experience, expertise and innovative insights
in a shared mission to help prevent and cure disease and bring significant life-saving treatments
to patients worldwide. For more than two decades, PAREXEL has been on the forefront of designing
effective partnership models, providing the perfect complement of clinical development expertise,
leading technologies and global access to our customers in order to meet their evolving needs.
In this regard, PAREXEL has received multiple awards honouring the Company’s performance,
including the biopharmaceutical industry’s Scrip Award for Best Contract Research Organization
in December 2008, which recognized PAREXEL’s consistent achievements in exceeding customer
expectations, as well as the Company’s broad range of services, its truly global nature, and the
positive impact it has had on advancing healthcare worldwide.
Contact Person:
Dr. Dieter Russmann
Adress:
Kartäuserstrasse 47,
D- 79102 Freiburg
Phone:
+49 (0) 761 2828 00
dieter.russmann@parexel.com
www.parexel.com
Headquartered near Boston, Massachusetts, PAREXEL operates in 70 locations throughout 52
countries around the world, and has more than 10,000 employees, including about 100 in
Freiburg, out of 1,500 in Germany.
Fraunhofer Institute for Physical Measurement
Techniques IPM
Fraunhofer Institute of Physical Measurement Techniques (IPM) is a part of Fraunhofer
Gesellschaft (FhG), which is Europe‘s largest contract research organisation. IPM develops
customer-specified measurement systems. The core competences are in the development of optical
components and of optical measurement systems and in thin film technology.
Contact Person:
Dr. Albrecht Brandenburg
In the field of biomedical optics, imaging systems and readout systems for biological chips are
developed. The work on imaging technology includes the development of cell monitoring
systems, which work under cell cultivation conditions. These systems are part of fully automated
cell cultivation systems, which are developed and built by a Fraunhofer consortium. Imaging
technologies have been developed also as a part of automated systems for the specific detection
and counting of aerosol particles, e.g. pollens.
Phone:
+49 (0) 761 8857 306
Adress:
Heidenhofstrasse 8
D- 79110 Freiburg i.Br.
albrecht.brandenburg@ipm.
fraunhofer.de
www.ipm.fraunhofer.de
Very sensitive systems for the readout of fluorescence biochips have been developed at IPM,
which can be produced at low cost. Prototype developments have been made for companies. Small
series of Biochip readers have been fabricated at IPM. Reader for integrated polymer cartridges,
containing fluidics, reagent vessels and microarrays are currently under development.
7
Laboratoire Altergen
ALTERGEN established in Strasbourg in 1989 is a laboratory of scientific and technical services in
the fields of biotechnology, biochemistry and molecular biology.
Adress:
2 avenue de L‘Energie
F- 67800 BISCHHEIM
In a few years’ time ALTERGEN has proved to be inevitable to those who trust efficiency, liability
and rapidity. It all lies in the subtile combination of academic research experience and industrial
knowledge of its founder Dr.-Ing. Iradj Amiri and his selected staff.
Diversity, sophistication and customer support are the values of this dynamic company which
is making constant efforts to adapt to scientific and technological progress while meeting the
involving needs and requests of the customers.
Phone:
+33 (33) 03 88 33 77 33
Service provided in the field of bio-organic molecules production and analysis such as:
Contact Person:
Dr.- Ing. Iraj AMIRI
altergen@wanadoo.fr
www.altergen.net
•• Custom peptide synthesis
•• Preparation of antigenic conjugates
•• Production of polyclonal antibody
•• Protein microsequence analysis
•• Micro-HPLC separation
•• Mass spectrometry analysis
Ernst & Young GmbH
Contact Person:
Dr. Siegfried Bialojan
Ernst & Young is a global leader in assurance, tax, transaction and advisory services. Worldwide,
our 141,000 people are united by our shared values and an unwavering commitment to quality.
We make a difference by helping our people, our clients and our wider communities achieve their
potential.
Adress:
Theodor-Heuss-Anlage 2
D- 68165 Mannheim
Phone:
+49 (0) 621 42 08 11 405
www.de.ey.com
Dr. Fenning BioMed GmbH
We develop and produce Enzyme Immuno Assays (EIA), which are used for diagnosing
various autoimmune diseases.
Contact Person:
Dr. Aline Cossy-Gantner
Our innovative and flexible approach enables us to react fast to changing market trends and to
proficiently implement new developments. This ability is supported by valuable contacts which we
maintain with several universities. Our co-operation with other biotechnology companies further
adds to our range of activities. Certification according to ISO 9001 and ISO 13485 stands for
consistent quality policy.
Adress:
Ottenstraße 6a,
D- 79199 Kirchzarten
The constant positive development of Dr. Fenning BioMed GmbH proves that our business concept
meets the requirements of our customers.
Phone:
+49 (0) 7661 9331-0
contact@fenningbiomed.de
www.fenningbiomed.de
8
aprentas
aprentas is the leading cooperative training association for basic and further education of
scientific, technical and commercial professions. It was founded ten years ago by the three patron
companies Ciba (now BASF), Novartis and Syngenta. Their goal was to maintain a sustainable,
continuous and inexpensive way of training people throughout the entire chemical and
pharmaceutical industry.
Meanwhile, many more companies have joined aprentas, and not only chemical-pharmaceutical
companies but also many technical and service enterprises. On behalf of its more than 60 member
companies, aprentas teaches more than 600 trainees in 13 different professions.
In addition to the basic education, aprentas also offers further vocational training. This range
of educational services is also open to non-members and encompasses around 200 courses
in the fields of laboratory, production, further management training, leadership and personal
development and the teaching of in-company trainers. Individually tailored courses can also be
ordered to suit specific company needs.
Contact Person:
Dr. Rolf Knechtli
Adress:
Mauerstrasse, Postfach
CH- 4002 Basel
Phone:
+41 61 696 10 39
rolf.knechtli@aprentas.com
www.aprentas.com
Analytical Services Dr. Ralph Nussbaum
Analytical Services is a privately held company located in Aachen, Germany. Analytical Services
provides analytical support, reference standards and technical writing for the Pharmaceutical
Industry. We are specialized in characterisation of impurities, method development, method
validation and CMC-documentation. Our analytical experts are supported by an efficient Project
Management.
What makes us different:
•• Handling of highly potent drugs
•• Permission for controlled drugs
•• Expertise for genotoxic impurities, leachables and extractables
•• Supply and qualification of reference standards
•• EU batch release by Qualified Person
•• Efficient Project Management
Contact Person:
Dr. Ralph Nussbaum
Adress:
Pauwelsstrasse 19,
D-52074 Aachen
Phone:
+49 (0) 241 963-2150
ralph.nussbaum@analyticalservices.com
www.analytical-services.com
Oncotest GmbH
Oncotest is a globally acting contract research organization (CRO) based in Freiburg, Germany.
Beside own preclinical research on human, patient derived cancer models and cancer therapeutics,
Oncotest offers its capabilities and unique tumor collection of more than 200 human tumors
to customers. We perform preclinical research projects for pharmaceutical and biotechnology
companies engaged in anti cancer drug development.
Contact Person:
Dr. Ingmar Peitz
Adress:
Am Flughafen 12,
D- 79108 Freiburg
Phone:
+49 (0) 761 51 55 942
ingmar.peitz@oncotest.de
www.oncotest.de
9
anterio consult & research GmbH
Contact Person:
Tassilo Eckerle, Sales Manager
Adress:
Augustaanlage 23,
D-68165 Mannheim
Phone:
+49 (621) 400 41-34
www.anterio.com
anterio has three different areas of expertise: IT Consulting, Research IT and Pharmaceutical
Research. We design IT architectures, offer remote as well as on-site support and act as your
strategic IT outsourcing partner.
For more than 10 years anterio develops independent and customer-oriented solutions. Our
customers benefit from the experience of anterio’s experts in manifold IT environments in several
industries.
We manage software installations, test new versions and manage the environment around it.
Customers benefit from our contact network. Our services are designed to cover your specific needs
by an individual configuration based on modules as:
•• Services for all common OS
•• Monitoring and remotes support
•• Full service or support on demand
•• Individual IT concepts for your business
•• Hosting and housing
•• Backup and recovery sceneries for your data
•• Development of software and data bases solutions
•• Administration and tuning of data bases
•• Independent delivery of hardware
•• Stereoscopic 3-D solutions
You always benefit from:
•• Flexible contract times, modular contract layouts
•• No call centre redirect: always a system engineer for you available
•• Definition of individual SLA; conformity to ITIL
•• Trouble ticket system for precise handling and accounting of service times
Eurofins GeneScan GmbH
Contact Person:
Christoph Bahrdt
Adress:
Engesserstr. 4
D- 79108 Freiburg i.Br.
Phone:
+49 (0) 761 5038 100
c.bahrdt@genescan.com
www.genescan.de
Eurofins is an international group of laboratories across 150 sites in 30 countries, providing an
unparalleled range of testing and support services to the pharmaceutical, food, environmental and
consumer products industries and to governments. Through research and development, the group
draws on the latest developments in the field of biotechnology and analytical sciences.
As one of the world‘s leading commercial GMO testing laboratories, Eurofins GeneScan has
extensive experience in DNA extraction from a broad range of sample types and made significant
contributions to the development of standardized methods for GMO analysis by PCR.
Eurofins GeneScan has more than 10 years of experience in Residual DNA testing applying highly
sensitive state-of-the-art techniques. Testing can be performed from research level to testing
regulated according GMP.
We offer Residual DNA analysis by PicoGreen and qPCR assays, with sensitivity well below the
mandated detection limit for Residual DNA assays. For specific detection and quantification of
Residual DNA from current host organisms (e.g. E. coli, CHO cells) qPCR assays are available.
Furthermore we offer customer-specific development of DNA extraction methods and qPCR
assays including automated solutions for higher throughput and implementation in the testing
laboratory.
10
CONFARMA France SARL
CONFARMA was founded 1972 as a neutral scientific services provider for the pharmaceutical,
biotech, cosmetic and medical device industries.
Now, CONFARMA is an international company with sites in Switzerland, Germany and France and
approx. 70 employees.
The range of services expanded over the years and includes physico-chemical, microbiological,
biological, biochemical, immunological, pharmacological-toxicological analysis, stability studies
and consulting.
The 1600 m2 and 600 m2 laboratory facilities are up to date, particularly in areas of rapid
technology development such as immunology, biochemistry, cell and molecular biology.
The group offers scientific services compliant with the latest requirements of authorities. Recently
CONFARMA developed services for Biotec and Biopharmaceutical. CONFARMA operates worldwide
with more than 250 clients.
Contact Person:
Ralf Holzinger
Adress:
ZI, rue du Canal d‘Alsace
F- 68490 Hombourg
Phone:
+33 389 833 720
rholzinger@confarma.fr
www.confarma.ch
CONFARMA has all necessary technological platforms for R & D activities, preclinical and clinical
phases, CMC, stability studies and quality control:
•• In vitro, Ex vivo, In vivo models
•• Electrophoresis and Blotting
•• PCR and Sequencing
•• Typing and analysis of fragments
•• Chromatography
•• Atomic absorption
•• Mass spectrometry MALDI-TOF-TOF
•• Spectrophotometry
•• Microscopy
•• Isolators and clean room
•• 8 ICH stability chambers
CONFARMA possesses c-GMP compliance by FDA, GMP and GLP certifications from AFSSAPS and
SwissMedic, and ISO 9001, 17025, 14001 and OHSAS 18001.
ProQinase GmbH
ProQinase is a leading service provider dedicated to support Pharmaceutical and Biotech
companies in the development of novel therapies for cancer treatment. The company has a longlasting scientific experience in the fields of tumour angiogenesis and protein kinase research.
ProQinase offers a product panel of more than 200 recombinant protein kinases, a broad panel
of biochemical, cellular and in vivo off-the-shelf services, and also custom-tailored solutions for
many steps of preclinical drug development in oncology.
The off-the-shelf service portfolio comprises profiling with 340 biochemical kinase assays,
cellular protein kinase assays, a variety of functional cellular assays (e.g. cell migration assays,
soft agar assays and an angiogenesis assay), as well as subcutaneous in vivo tumour models
(xenografts), orthotopic in vivo tumour models with bioluminescence imaging, and a unique in
vivo angiogenesis model.
Contact Person:
Dr. Christoph Schächtele,
Managing Director
Adress:
Breisacher Str. 117,
D- 79106 Freiburg
Phone:
+49 (0) 761 206 1710
c.schaechtele@proqinase.com
www.proqinase.com
11
EUCRAF Ltd.
Contact Person:
Lisa Weiss (Program Manager)
Adress:
Wippertstr. 2
D- 79100 Freiburg i.Br.
Phone:
0176 13 73 44 24
lisa.weiss@eucraf.eu
www.eucraf.eu
EUCRAF (European Center for Regulatory Affairs Freiburg) offers the postgraduate Master
Programme “Regulatory Affairs for Biopharmaceuticals” and Workshops on specific current topics
in the field of pharmaceuticals.
The Programme was founded by Dr. Gabriele Dallmann together with experts from Universities, the
EDQM, Agencies and the pharmaceutical Industry to train young people in the field of Regulatory
Affairs. For the first time in Europe the Programme has been dedicated to Biopharmaceuticals
which become more and more important for the pharmaceutical industry.
The programme is of interest to graduates of pharmacy, other life sciences or health subjects. It
can be completed within 1-2 years part-time collaterally to professional responsibilities.
The training of EUCRAF is very practice-orientated and teaches the essential skills of a regulatory
affairs professional. It allows the attendees to pursue a career in pharmaceutical companies of all
sizes and health authorities involved in the development and authorization of medicinal products.
ChemCon GmbH
Contact Person:
Mr. Reinhard Hirsch
Adress:
Engesserstraße 4b,
D-79108 Freiburg
Phone:
+49 (0) 761 5597-443
reinhard.hirsch@chemcon.com
www.chemcon.com
ChemCon - Good Manufacturing Partner:
Chemical excellence at work for your project’s success
Custom Project Research – Contract Manufacturing
ChemCon´s emphasis is in custom project research as well as chemical synthesis and GMP
manufacturing. Important areas of expertise are the transfer of a developed process to GMP in
scales from milligram to multi-kilogram, active pharmaceutical ingredients for clinical studies
up to commercial grade, specialty chemicals, bioinorganic reference substances and research
chemicals.
ChemCon GmbH is still a private company owned by its founders, a company in the area of
industrial production which, through its innovative technical services, has developed a process to
enable rapid market introduction of new medical substances for countless companies.
Continuous and customer-oriented expansion of our services and quality standards for the
pharmaceutical and biotech industries is our focus. In December 2009 we successfully passed a
certification audit based on ISO 9001:2008 without any discrepancies. DEKRA Certification GmbH
certified ChemCon GmbH and ChemCon America, Inc. with an extensively developed and practiced
quality management system with structured processes.
Multiple GMP inspections by the health authority of the USA, FDA (2000 and 2007), and the
Regional Administrative Authority of Tübingen (2006 and 2007) were likewise passed without
major observations.
12
BGA Group GmbH
BGA Group is a modern, forward-thinking, full-service, business communication agency. This
means that we have the full range of capabilities in-house to allow us to oversee every stage of
the creative process. Owner-managed, inter-cultural and highly motivated, we strive to deliver the
perfect solutions for our clients’ needs.
The company’s USP is founded on our core qualities; German precision, international experience
and a global culture. With offices in four strategic locations in Germany, the UK, the Netherlands
and the USA, we are strategically placed to fulfill the demands of our customers.
BGA Group has its core focus on companies and organizations working in the life sciences,
technology and medical healthcare markets, with clients ranging from Fortune 50 corporations
to non-profit organizations. BGA Group associates include former top executives from major life
science companies and organizations; we speak the language of our clients and understand their
products and markets. Our team of over 40 employees has a track record of delivering optimal
services for our clients. with a focus on delivering results and sales driven solutions.
Contact Persons:
Helga Mirring, Ian Boult
Adress:
Munzinger Str. 1,
D-79111 Freiburg
Phone:
+49 (0) 761 40086 0
info@bgagroup.net
www.bgagroup.net
BGA Group covers the complete marketing spectrum from initial market analysis, through to
strategic campaign management for all your print, internet, multi-media, e-commerce and video
requirements.
CellGenix GmbH
CellGenix GmbH is a biopharmaceutical company active in the field of cellular therapies and
regenerative medicine. CellGenix was founded in 1994 and is located in Freiburg, Germany.
The company develops, manufactures and markets cell therapy products and high-quality reagents
for ex vivo cell culture. CellGenix is a leading supplier of GMP (Good Manufacturing
Practice) manufactured cytokines and serum-free media for cell therapy applications worldwide.
As the first European company to obtain a GMP manufacturing authorization for cell processing in
Europe CellGenix continues to build on more than 15 years of in-house experience in clinical cell
therapies.
Today, CellGenix‘ fully owned subsidiary Metreon Bioproducts GmbH continues to provide GMP
allogeneic cord blood stem cells and CartiGroTM autologous chondrocytes to our cooperation
and distribution partners.
Contact Person:
PD Dr. Felicia M. Rosenthal
Adress:
Am Flughafen 16,
D- 79108 Freiburg
Phone:
+49 (0) 761 88889-0
info@cellgenix.com
www.cellgenix.com
Our products are used by leading experts and proven in clinical trials throughout the world.
With the unique background in GMP manufacturing of both cell therapy products and recombinant
protein pharmaceuticals and the track record in clinical application CellGenix is ideally positioned
to become Your Partner for Clinical Cell Therapy.
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Swiss BioAnalytics AG
Swiss BioAnalytics (SBA) is a privately owned bioanalytical Contract Research Organization
based in Basel-Birsfelden. SBA provides quantitative and qualitative analytical services for the
pharmaceutical industry across all phases of the drug development and registration process. This
includes
Contact Person:
Winfried Wagner-Redeker
Adress:
Sternenfeldstrasse 14
CH- 4127 Birsfelden
Phone:
+41 (61) 317 2390
w.redeker@swissbioanalytics.com
www.swissbioanalytics.com
•• Pharmacokinetic and toxicokinetik studies in preclinical trials
•• Pharmacokinetic studies in clinical phases 1, 2 and 3
•• Bioanalysis for bioequivalence studies
•• Metabolite profiling and metabolite identification
•• Total mass balance studies
•• Formulation studies, including identification of byproducts, degradation products
The company was founded in 1999. Currently it operates 11 HPLC/MS workplaces. Nine of these
workplaces are equipped with triple stage quadrupole mass spectrometers and two with ion traps
(LTQ, LTQ-Orbitrap). Sample preparation covers all modern techniques including on-line methods.
The staff has the skills and the equipment to process highly specialized assays with limited
number of samples as well as large studies with thousands of analyses involved. The company
currently has 30 employees, chemists, pharmacists, laboratory technicians and staff with an
administrative and business education.
Zimmer Germany GmbH
Zimmer Holdings, Inc. was founded in 1927 and is headquartered in Warsaw, Indiana. Zimmer
engages in the design, development, manufacture, and marketing of orthopaedic reconstructive
implants, spinal and trauma devices, dental implants, and related surgical products.
Contact Person:
Lothar Kiontke
Adress:
Merzhauser Strasse 112
D- 79100 Freiburg
Phone:
+49 (0) 761 45 84 01
lothar.kiontke@zimmer.com
www.zimmergermany.de
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Zimmer owns subsidiaries in more than 25 countries and sells its products in more than 100
countries. In 2009 the company generated netsales of 4.1 billion USD and has more than 8000 full
time employees.
Albert-Ludwigs-University Freiburg - Intelligent
Embedded Microsystems (IEMS)
The University of Freiburg offers a wide range of advanced extra-occupational courses for working
engineers, developers or researchers in the field of embedded systems.
Contact Person:
Martina Welte,
Student Advisory Service
Each course takes six months and is mostly held online with few and short attendance periods, so
you are extremly flexible regarding the time and location of your studies. The courses are mostly
in step with actual practice and you can individually select the topics of your interest: there are
some basic courses in Computer Science and Engineering as well as specialized courses in a variety
of core areas of embedded systems; you can also take additional courses in project management or
industrial property protection.
Adress:
Georges-Köhler-Allee 51
D- 79110 Freiburg i.Br.
Participants profit from a transfer of knowledge and newest research results from the University
into their companies, which therefore also benefit from the training. The courses conclude with a
certificate of the University of Freiburg, that is be recognized, if the participant decides to do the
Masters Course “Intelligent Embedded Microsystems“.
Phone:
+49 (0) 761 203 4436
iems@weiterbildung.unifreiburg.de
www.masteronline-iems.de
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BioValley Companies Day
Financed by:
Impressum
Herausgeber:
Gestaltung:
Abbildungen:
BioValley Deutschland e.V.
Ulrike Claassens Grafik Design
Ulrike Claassens