Wacker Biotech, Fresenius collaborate produce antibody fragments

Wacker Biotech, Fresenius collaborate to produce antibody fragments

6:25 AM, 9th March 2017
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MUNICH/ JENA, GERMANY: Wacker Biotech GmbH, a wholly-owned subsidiary of Wacker and Fresenius Medical Care Adsorber Tec, a subsidiary of the globally active healthcare Wacker Biotech GmbH Group Fresenius, have reached an important milestone in their collaboration aimed at producing a scFv-class antibody.

Using its E. coli-based FOLDTEC technology, Wacker completely overhauled a process employed by Fresenius Medical Care to facilitate production on an industrial scale. Wacker's proprietary refolding technology was able to produce the desired recombinant product in enhanced yields and higher purity than was hitherto possible while slashing buffer volumes.

Furthermore, the new process has already been transferred into a GMP-compliant industrial-scale production. The manufactured antibody fragment is used in apheresis products for selective dialysis.

In its search for an efficient process capable of industrial-scale production of its antibody fragment for an apheresis application, Fresenius turned to Wacker for assistance. Wacker was tasked with developing a stable process which would employ microbial systems to produce the therapeutic candidate and which could be scaled up from the laboratory to the industrial level.

Wacker subsequently completely overhauled Fresenius's existing process and deployed its own proprietary FOLDTEC refolding technology. With this technology, microbially produced pharmaceutical proteins, which form inclusion bodies during production, can be manufactured cost-effectively and reliably in high yields and extremely high purity. The patented process utilises specifically developed and optimised E.coli bacterial strains and a patented, antibiotic-free expression system.

The FOLDTEC toolkit gives Wacker Biotech extensive expertise in the targeted screening of optimum refolding conditions needed for converting the insoluble target-protein aggregates into a biologically active form.

“Having successfully established our ESETEC technology for Fab fragments, FOLDTEC demonstrates what we can now do for scFv fragments – and underscores our leading position in the efficient production of antibody fragments. Our customers really appreciate our unique technological solutions for these new product classes because it means they can provide their patients with better products faster,” emphasised Maier,” said Dr Thomas Maier, managing director of Wacker Biotech.

“In Wacker, we have found a highly competent partner for ensuring that we have a secure supply of raw materials for our industrial scale production,” added Dr Wolfram Strobl, general manager of Fresenius Medical Care.

© Worldofchemicals News 

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