Biotop-report 2013

47

BioTOPics 46 | September 2013 

BioTOP-Report

ProBioGen AG

ProBioGen AG is an internationally operating 

Contract Development & Manufacturing 

Organization (CDMO) and Technology Pro-

vider, focused on animal cell line engineer-

ing and process development including GMP 

manufacturing of biopharmaceutical drug 

substances (therapeutic proteins and vac-

cines). 

Almost 20 years of experience in mammali-

an cell culture and biopharmaceutical manu-

facturing make ProBioGen a competent and 

reliable contract partner. The comprehensive 

technological skills and the outstanding sci-

entific excellence, reflected in a strong intel-

lectual property base, qualify ProBioGen to 

manage even the most challenging develop-

ment and manufacturing projects. 

The pharmaceutical cell line development 

program is based on proprietary expression 

vector technology, optimized clone selection 

and screening workflow complemented by 

an in-house chemically defined cell culture 

media platform. Two preselected CHO host 

cell lines (DG44- and K1-strains for optimal 

product quality) fit perfectly into the rapid 

upscale processes and achieve excellent 

product yields and stability. Comprehensive 

analytical methods development and valida-

tion goes hand in hand with state-of-the-art 

GMP manufacturing programs.

All services and technologies are embedded 

in a total quality management system to 

assure compliance with international ISO 

and GMP standards (EMA/FDA).

An experienced project management 

ensures that projects are completed strictly 

in time and on budget.

Besides the state-of-the-art services, ProBio-

Gen develops innovative technologies, such 

as: 

 

k

GlymaxX

®

 

This fucose-targeted glyco-engineering 

technology increases the binding of 

antibodies to NK cells and thus enhances 

ADCC. As a permanent modification it 

can be rapidly applied to any existing 

antibody producer cell lines or to entire 

expression platforms. 

 

 

k

Pathway Modulator Technology 

This permanent cell modification increas-

es productivity even for difficult to 

express proteins. It is applicable to new 

and pre-existing producer cell lines. 

 

k

AGE1 Designer Cell Lines 

The AGE1 cell line family was created by 

defined immortalization of primary cells 

for different purposes. 

 

k

The AGE1.CR

®

 cell line originates from 

the Muscovy Duck and was established 

to replace primary chicken cells in vac-

cine production. The cell line allows 

GMP-complaint production of a wide 

spectrum of vaccines and viral vectors.  

 

k

The AGE1.HN

®

 human neuronal cell line 

supports complex specific glycostruc-

tures (highly sialylated, highly branched). 

It is used for glycoproteins which require 

manufacturing in human cells.  

 

k

Human Artificial Lymph Node 

(huALN)  

The huALN is a fully human mini-

bioreactor system to assay drug-related 

effects on the immune system in vitro. 

This unique 3-D matrix-based technology 

uses primary lymphocytes to emulate in 

vivo conditions of the human immune 

system and allows long-term analyses of 

immunogenicity, immunofunction and 

immunotoxicity. 

Founded in 1994, ProBioGen is located in 

Berlin, Germany, and enjoys a global cus-

tomer portfolio ranging from small biotech 

firms to large pharmaceutical companies.

Address

ProBioGen AG

Goethestraße 54

13086 Berlin · Germany

Contact

Dr. Gabriele Schneider

VP Business Development

Phone [phone]

Fax 

[phone]

[e-mail]

www.probiogen.de

---

48

BioTOPics 46 | September 2013 

BioTOP-Report

syneed medidata GmbH

Are you getting the whole picture? 

We Do.

syneed medidata GmbH is an independent, 

privately owned contract research organiza-

tion (CRO) that has been providing end-to-

end services for phase I to phase IV clinical 

trials and for observational studies for more 

than 25 years. Since 1995, we have also 

excelled in trials with medical devices, and 

in trials involving medical imaging, including 

all responsibilities of an Imaging Core Lab 

(ICL). With our exceptionally low staff turn-

over, project teams usually remain stable, 

even throughout multi-year projects, and as 

such facilitate project delivery in time and 

highest quality.

syneed medidata GmbH combines experi-

ence with the quality, dedication and 

flexibility of a midsized organization. Our 

proprietary EDC system, tailor-made for 

multinational observational studies, gets 

enthusiastic feedback from both customers 

and end-users. Its advantages are, among 

others, unlimited flexibility in study design 

and multilingualism, compatibility with iPad 

and Android tablets, and an attractive price/

performance ratio. 

So, for almost any trial you can think of, we 

provide the expertise you need for turning 

data into results.

Address 

syneed medidata GmbH

Cicerostraße 21

10709 Berlin · Germany

Phone [phone]

www.medidata.de

[e-mail]

Contact 

Dr. Achim Zinggrebe

CEO

Medical Director Imaging 

[e-mail]

syneed imaging

syneed imaging, the Medical Imaging Core 

Lab of syneed medidata GmbH, offers solu-

tions for study planning, protocol develop-

ment, site evaluation, image collection and 

processing and conduct of central indepen-

dent reviews with a wide variety of criteria 

(i.e. RECIST, 1.0 and 1.1, Choi, Cheson, irRC, 

RANO, PERCIST, mRECIST).

Since 1995, we have managed trials involv-

ing medical imaging (oncology, neurology, 

radiology, devices) and conducted central 

reads in our offices in Constance and Berlin 

as well as remotely. Our experience, flexibil-

ity and pricing especially for early phase tri-

als are highly valued by Biotech clients. All 

study data are hosted solely in Germany on 

our servers maintained by own IT staff.

Address

syneed imaging & syneed medidata GmbH

Cicerostraße 21

10709 Berlin · Germany

Phone [phone]

 

Contact

Isabel Kloer

MD

Medical Director Imaging 

[e-mail]

Full-service for clinical trials

Proprietary EDC system

Very high staff retention

Tailor-made services instead of 

one-size-fits-all approaches

High experience of staff

High quality delivered while being 

reasonably priced

---