In its search for an efficient process capable of industrial-scale production of its antibody fragment for an apheresis application, Fresenius Medical Care 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 Medical Care'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 utilizes specifically developed and optimized 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.
Not only did the results confirm that the FOLDTEC® technology is suitable for the production of the single-chain variable fragment (scFv) from Fresenius Medical Care. The new process was also found to slash buffer volumes while enhancing yields and boosting purity. Since then, WACKER has already succeeded in rendering the industrial-scale production process GMP-compliant. The upscaled, efficient process is essential for ensuring security of supply for Fresenius Medical Care and ultimately ensuring that the apheresis product is available in sufficient quantities for patients.
“We are delighted with the successful collaboration with Fresenius Medical Care,” said Dr. Thomas Maier, managing director of Wacker Biotech GmbH. “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,” emphasized Maier.
“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,” said Dr. Wolfram Strobl, General Manager of Fresenius Medical Care Adsorber Tec GmbH.
About Wacker Biotech: The Microbial CMO
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, Germany. Above all, Wacker Biotech offers proprietary technologies that satisfy market needs for cost-efficient production and maximum quality. Based in Jena and Halle, Wacker Biotech is a wholly-owned WACKER subsidiary.
For further details, visit the following website: http://www.wacker.com/biologics