cGMP manufacturing for (pre-)clinical trials ... - Eurogentec

Therapeutic
Oligonucleotides
cGMP manufacturing
for (pre-)clinical trials

New from Eurogentec: Therapeutic Oligonucleotides
Oligonucleotide-based drugs are now rapidly establishing themselves as important tools
in both research and treatment of genetic disorders. Recent knowledge about RNA
interference has boosted interest in this field. An increasing number of oligonucleotidebased
pharmaceutical products are now in in various stages of clinical development for
the treatment of life-threatening so far incurable diseases. As a result, the production of
synthetic oligonucleotides has become increasingly important, with applications in
antisense-, aptamer-, immunostimulatory CpG molecule- and RNAi-related therapeutics.
In response to this development, Eurogentec Biologics, leader in GMP manufacturing of
biopharmaceuticals and Eurogentec Genomics, expert in oligonucleotide synthesis and
purification, have joint forces to offer a new service: cGMP manufacturing of
oligonucleotides for therapeutic use.
Global solution in one company: from target discovery to
clinical trials
Eurogentec’s approach in building a new team with synergistic expertise has resulted in a
unique service that helps minimize the risks attached to outsourcing manufacturing in
oligonucleotide drug development. By offering small-scale non-cGMP oligonucleotides for
target discovery and pre-clinical toxicology studies (typically less than 1 gram) and
mid-scale cGMP oligonucleotides for human clinical trials (up to 10 gram), we deliver an
integrated manufacturing program that enables seamless transition from target discovery
and pre-clinical studies to clinical trials.
� Expertise to produce complex and modified oligonucleotides (siRNA, LNA, 2’OMe…).
� Expert advice on oligonucleotide design and delivery systems.
� Dedicated cGMP facilities for RNA and DNA production.
� Capacities from milligrams to 10 gram and beyond.
� Lab and industrial scale purification systems.
� Ultra filtration and freeze drying.
� Clean rooms for purification and isolation.
� Full range of QC release testing specific to oligonucleotides.
� Biodistribution and design services
About Eurogentec Biologics
The Biologics Division of Eurogentec is a leading contract manufacturer of
biopharmaceuticals for clinical trials and market supply. We offer cell banking, process
and analytical development and production of bacterial vaccines, recombinant or natural
proteins and plasmid DNA according to current GMPs of European and US regulatory
authorities. To date, Eurogentec Biologics has manufactured more than 270 clinical
batches of over 60 different drug substances. For the past 12 years, we have successfully
served small start-ups and large pharmaceutical companies in Europe and North America
and are committed to expand our services worldwide.
About Eurogentec Genomics
With over 20 years of experience in oligonucleotide synthesis, Eurogentec has grown into
a leading provider for genomic research as well as DNA- and RNA-based diagnostic
testing. Eurogentec maintains a proven track record of manufacturing the widest range
of oligonucleotide modifications in the industry. Being a healthy and professional
company, we are able to offer reliable, flexible and cost-effective solutions for research,
R&D and clinical use of oligonucleotides.

Eurogentec, your oligonucleotide partner of
choice in drug development.
For inquiries, please contact the EUROGENTEC Diagnostic Oligonucleotide Team:
IND-THERAPOLIGO-0507-V3
Customers in Europe and USA:
Tel.: + 32 (0)4 372 7437 (Muriel Craynest, Ph.D.)
Tel.: + 32 (0)4 372 7635 (Peter Haima, Ph.D.)
therapeutic.oligo@eurogentec.com
Customers in Asia:
Tel.: + 81 (0)76 411 02 77 (Japan)
info@n-egt.com
Tel.: + 65 (0)6778 9388 (Singapore)
therapeutic.oligo@eurogentec.com