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BIO-EUROPE 2015: WACKER Presents Proprietary FOLDTEC® Refolding Technology for the Cost-Efficient Manufacture of Highly Pure Pharma Proteins

Munich and Jena, Sep 09, 2015

At this year’s BIO-Europe, Wacker Biotech is showcasing its novel refolding technology for bioengineered pharmaceutical proteins. With FOLDTEC®, biopharmaceuticals that tend to aggregate can be efficiently produced in their soluble-active form in high yields. The proprietary process utilizes specifically developed and optimized bacterial strains and a patented, antibiotic-free expression system. Furthermore, Wacker Biotech offers extensive expertise in the targeted screening of optimum refolding conditions in order to convert the insoluble target-protein aggregates into a biologically active form. Thanks to FOLDTEC®, WACKER can now cost-efficiently and reliably produce pharmaceutical proteins that are prone to aggregation, and thus difficult to manufacture, in high yields and utmost purity for its customers. BIO-Europe takes place in Munich, Germany, from November 2 – 4, 2015.

Proteinrückfaltung im industriellen Maßstab
Industrial-scale protein refolding: with the novel FOLDTEC® refolding technology, microbially produced pharmaceutical proteins can be manufactured cost-efficiently and reliably in high yields, without the need for antibiotics or phage components.

At the BIO-Europe tradeshow, WACKER is launching its proprietary refolding technology for microbially produced pharmaceutical proteins that form aggregates – so-called inclusion bodies – during their manufacture. While WACKER’s own ESETEC® technology has proven highly efficient in producing soluble proteins and antibody fragments via secretion, some protein classes (such as cysteine-knot proteins and some single-chain antibody fragments) form aggregated inclusion bodies within the cell, which contain incorrectly or incompletely folded target molecules. So, protein refolding is a key production stage in order to achieve the desired active properties.

With the novel FOLDTEC® technology, such pharmaceutical proteins can now be manufactured and refolded easily and cost-effectively. This proprietary process utilizes high-expression plasmids and a patented E.coli strain that produce the desired proteins in high yields of up to 12 grams per liter. After cell harvesting, the proteins can be easily and quickly converted to their native conformation. Furthermore, the bacterial strain features particularly high plasmid stability – without any unwelcome additives or impurities. While conventional systems usually depend on antibiotics, FOLDTEC® can do without them entirely. It also completely avoids phage components, which are generally needed by comparable systems. Both of these aspects contribute to the new technology’s high safety and environmental compatibility and meet the strictest of regulatory requirements.

Beside the patented E.coli host strain, WACKER offers extensive experience and expertise in high-cell-density fermentation and industrial refolding processes as part of its FOLDTEC® toolbox. This knowledge is applied directly to customer projects for the rapid identification of optimum process parameters and folding conditions. Extremely high yields of correctly folded protein actives can thus be achieved. This makes FOLDTEC® an extremely efficient and safe production method.

“With the new FOLDTEC® refolding technology, we underline our longstanding reputation as an innovation driver in microbial systems,” said Dr. Thomas Maier, managing director of Wacker Biotech GmbH. “Alongside our established ESETEC® secretion technology, FOLDTEC® now offers our customers a unique solution for proteins prone to aggregation – it further strengthens our position as a full-service provider for the cost-efficient and safe microbial production of pharmaceutical proteins.”

About Wacker Biotech

Wacker Biotech GmbH is a full-service contract manufacturer of bio-pharmaceutical 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

Visit WACKER at BIO-Europe 2015.

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Wacker Chemie AG
Media Relations & Information
Nadine Baumgartl

Tel. +49 89 6279-1604
Email nadine.baumgartl@wacker.com
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