Company offers a high yield solution for pharmaceutical proteins that are prone to aggregation and difficult to manufacture
Wacker Biotech will showcase its novel refolding technology for bioengineered pharmaceutical proteins, at BIO-Europe to be held on 2–4 November in Munich, Germany. With FOLDTEC, biopharmaceuticals that tend to aggregate can be produced in their soluble-active form in high yields.
The proprietary process uses specifically developed and optimised bacterial strains and a patented, antibiotic-free expression system. Furthermore, Wacker offers extensive expertise in the targeted screening of optimum refolding conditions to convert the insoluble target protein aggregates into a biologically active form.
Although the company’s ESETEC technology is able to produce soluble proteins and antibody fragments via secretion, some protein classes form aggregated inclusion bodies within the cell that contain incorrectly or incompletely folded target molecules. As such, protein refolding is a key production stage to achieve the desired active properties.
With FOLDTEC, such proteins can now be manufactured and refolded easily and cost-effectively. This proprietary process uses high-expression plasmids and a patented E. coli strain that offers protein yields of up to 12g/L. Post-harvesting, the proteins can be easily and quickly converted to their native conformation.
Furthermore, the bacterial strain features particularly high plasmid stability — without additives or impurities — and the system is antibiotic free. High cell density fermentation and industrial refolding processes are also included in the part of FOLDTEC toolbox.
‘With the new FOLDTEC refolding technology, we’re underlining our longstanding reputation as an innovation driver in microbial systems,’ said Dr Thomas Maier, Managing Director of Wacker Biotech. ‘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.’