Wacker Biotech grants MedImmune licence to use Esetec technology to manufacture antibody fragment

To help improve productivity and simplify the purification process

Wacker Biotech, a subsidiary of German chemical company Wacker Group, has signed a licensing agreement with MedImmune for the use of its Esetec technology in E.coli.

No financial details have been released.

The agreement allows the global biologics research and development arm of AstraZeneca to use Wacker’s Esetec 2.0 cell line exclusively for the production and commercialisation of an antibody fragment (Fab). Fabs are purpose-made constituents of human antibodies and represent a promising growth area for the pharmaceutical industry.

A feasibility study conducted by the two firms demonstrated that Esetec 2.0 was superior to existing technologies for the production of Fabs. It provided a high yield of correctly folded and biologically active Fab, as well as exhibiting enhanced productivity, which outperformed industrially optimised processes for mammalian cell cultures (CHO cells), Wacker said.

Based on this study, both firms agreed to produce the Fab at one of Wacker’s cGMP (current Good Manufacturing Practice) facilities.

Dr Thomas Maier, Managing Director of Wacker Biotech, said: '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 with conventional CHO mammalian cell techniques.'

Wacker says the advantages of Fabs over whole antibodies are their ability to penetrate into the tissue and that they can be produced in microbial systems. The second-generation Esetec secretion technology makes high product yields of several grams per litre 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.'

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