ESETEC® 2.0 Market Launch: WACKER Achieves Successful Results in Project with MedImmune

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Munich / Jena, October 21, 2014 – Wacker Biotech GmbH, a subsidiary
of the WACKER Group, has recently completed a feasibility
study with MedImmune, the global biologics research and
development arm of AstraZeneca, for an antibody fragment using
WACKER’s improved proprietary secretion technology,
ESETEC® 2.0. MedImmune commissioned this work in an effort
to identify a cost-effective methodology for antibody fragment
production for future therapies. The yields achieved with this
enhanced version of the E. coli-based secretion system exceeded
those of the original ESETEC® technology by a factor of four.

WACKER has profoundly refined its patented ESETEC® system, which is based on Escherichia coli bacteria, for the manufacture of
pharmaceutical proteins. Targeted genetic modifications and process optimization measures led to the development of new, extremely productive cell lines and fermentation procedures. As a result, complex molecules such as antibody fragments (Fab) can now be produced in yields of several grams per liter and can be secreted into the culture medium in active form. In July 2014, this advancement was awarded the “Alexander Wacker Innovation award,” which distinguishes outstanding research work within the WACKER Group.

Within only six weeks after obtaining the genes, WACKER was able to successfully produce MedImmune’s Fab antibody fragment and has achieved significant yields with its established ESETEC® technology. The new ESETEC® 2.0 version managed to surpass even
these results: it delivered four times higher yields of correctly folded, fully functional antibody fragments in the culture medium when compared to the established ESETEC® system. MedImmune has confirmed that the secreted fab was correctly assembled and bound to its target in vitro.

The results not only verify that, for the production of antibody fragments that are difficult to manufacture, ESETEC® technology is superior to established technologies. The findings also show that the new ESETEC® 2.0 version offers advances in productivity that exceed industry optimized processes for mammalian cell cultures (CHO cells). Alongside the high yields that could be demonstrated for a variety of Fab antibody fragments, the production speed offers considerable advantages. With the new system, it only takes a few weeks to establish an efficient and industrial-scaled fermentation process for the manufacture of a Fab antibody.

“We are very pleased that our intensive research is now bearing fruit and that ESETEC® 2.0 can unfold all of its benefits for our customer MedImmune,” says Dr. Thomas Maier, managing director of Wacker Biotech. “Compared to the development with mammalian cell cultures, our customers can save time on the long product-development journey with ESETEC® 2.0 and additionally profit from cost-effective bacterial manufacturing processes. We are proud that our innovation, paired with our extensive GMP experience, is gaining acceptance on the market.”

Fab antibody fragments are purpose-made variants of human antibodies and represent a highly promising growth area for the pharmaceutical industry. Their advantages over whole antibodies are chiefly their greater ability to penetrate into the tissue and production in microbial systems. Their widespread therapeutic use has been hampered by the absence of a low-cost production method – until now. The second-generation ESETEC® secretion technology makes high product yields of several grams per liter possible.

About ESETEC®
ESETEC® is a proprietary WACKER technology with a track record of cost-effective production of proteins and antibody fragments. It is based on an E. coli K12 strain, which has a particular ability to secrete recombinant proteins into the culture broth in the correct folding conformation during fermentation. Secretion into the broth facilitates purification of the target protein, since complicated process steps such as homogenization and refolding are unnecessary. This makes the entire manufacturing process significantly more efficient and costeffective. With the enhanced, second-generation ESETEC® system, complex molecules such as antibody fragments can also be produced in high yields and secreted into the culture medium in active form. A number of biologics manufactured with ESETEC® are already being evaluated in preclinical and clinical trials.

About Wacker Biotech
Wacker Biotech GmbH is a full-service contract manufacturer of biopharmaceutical products based on microbial systems. The company’s services range from molecular biology, analytical services and process development through to the GMP-compliant manufacture of clinical test samples and pharmaceutical actives for the commercial market at the GMP-compliant production plants in Jena and Halle. Above all, Wacker Biotech offers proprietary technologies that satisfy market needs for cost-efficient production and maximum quality. Based in Jena and Halle, Germany, Wacker Biotech is a wholly-owned WACKER subsidiary.

For further details, visit the following website:
http://www.wacker.com/biologics

För mer information, vänligen kontakta:

Wacker Chemie AG

Media Relations & Information

Nadine Baumgartl

Tel. 49 89 6279-1604

 Fax 49 89 6279-2604

 nadine.baumgartl@wacker.com

Företaget i överblick: WACKER är en globalt verksam kemikoncern med cirka 16.000 anställda och en årsomsättning på cirka 4,48 miljarder € (2013). WACKER har 25 produktionsanläggningar, 21 technical competence centers och 52 försäljningskontor över hela världen.

WACKER SILICONES Silikonoljor, silikonemulsioner, silikongummi och silikonhartser, silaner, pyrogena kiselsyror, termoplastiska silikonelastomerer

WACKER POLYMERS Polyvinylacetat- och vinylacetat-kopolymerer i form av dispersionspulver, dispersioner och fasthartser som bindemedel för byggkemiska produkter, färger, lim, lacker, putser och fiberdukar samt i polymera material baserade på återvinningsbara resurser.

WACKER BIOSOLUTIONS Bioteknologiska produkter såsom cyklodextriner, cysteiner och biologiska produkter liksom finkemikalier och PVAc fasta hartser

WACKER POLYSILICON Polysilicium för halvledar- och fotovoltaikindustrin

Siltronic Wafers av högrent silicium och enkristaller för halvledarkomponenter.

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