This agreement follows a feasibility study that the companies conducted, which demonstrated that WACKER’s ESETEC®2.0 technology was superior to existing technologies for the production of Fabs. Fabs are purpose-made constituents of human antibodies and represent a highly promising growth area for the pharmaceutical industry. The ESETEC® 2.0 technology provided a high yield of correctly folded and biologically active Fab. The technology also exhibited enhanced productivity, which outperformed industrially optimized processes for mammalian cell cultures (CHO cells).
Based on this successful study, both parties agreed to produce the Fab at one of WACKER’s cGMP (current Good Manufacturing Practice) facilities.
“We are extremely proud that our innovative secretion system is gaining ever greater market share: less than a year after ESETEC® 2.0 was launched commercially, a leading biotech company -MedImmune – has obtained a license,” said Dr. Thomas Maier, managing director of Wacker Biotech. “In regards to the production of hard-to-manufacture Fab, our proprietary system significantly outperforms commercially established processes. And our customers benefit from time savings and productivity gains compared to conventional CHO mammalian cell techniques.”
The advantages of Fabs over whole antibodies are their ability to penetrate into the tissue and that they can be produced in microbial systems. Their widespread therapeutic use has been hampered by the absence of a low-cost production method – until now. The second-generation ESETEC® secretion technology makes high product yields of several grams per liter possible.
“We are very pleased with the performance of Wacker’s ESETEC® 2.0 secretion technology in our development work to date,” said Gail Wasserman, Senior Vice President, Development, MedImmune. “This technology helps improve productivity and simplifies the purification process, which is critical as we work to bring important medicines to patients as quickly as possible.”
ESETEC® is a proprietary WACKER technology with a track record of cost-effective production of proteins and antibody fragments. It is based on an E. coli K12 strain, which has a particular ability to secrete recombinant proteins into the culture broth in the correct folding conformation during fermentation. Secretion into the broth facilitates purification of the target protein, since complicated process steps such as homogenization and refolding are unnecessary. This makes the entire manufacturing process significantly more efficient and cost-effective. With the enhanced, second-generation ESETEC® system, complex molecules such as antibody fragments can also be produced in high yields and secreted into the culture medium in active form. A number of biologics manufactured with ESETEC® are already being evaluated in preclinical and clinical trials.
About Wacker Biotech
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