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