Wacker Biotech and XL-protein Sign Long-Term Cooperation Agreement to Produce PASylated Biopharmaceuticals

Munich / Freising / Jena, October 30, 2012

Wacker Biotech GmbH and XL-protein GmbH are to collaborate more intensely on the production of PASylated therapeutic proteins. Today, the two companies announced the signature of an agreement to this effect. Through this collaboration, WACKER and its customers will gain access to XL-protein’s PASylation® platform. The PASylation® technology enables the development of biopharmaceuticals with extended plasma half-lives, which require less frequent injection and thus are more patient friendly. In a recent feasibility study, PASylated human growth hormone was successfully produced in high yields using WACKER’s E. coli-based ESETEC® technology.

In a feasibility study, Wacker Biotech and XL-protein tested WACKER’s patented ESETEC® technology for the production of large-sized PASylated therapeutic proteins. The study showed that ESETEC® produced a PASylated human growth hormone – correctly folded and fully functional – in high yields (3 to 4 g/l). Moreover, WACKER successfully used its secretion technology to develop an E. coli cell line for manufacturing the PASylated hormone. The production process is easy to implement on an industrial scale.

“Following the successful feasibility study, we are very much looking forward to intensifying our collaboration with XL-protein,” said Dr. Thomas Maier, managing director of Wacker Biotech GmbH. “More and more pharmaceutical companies are looking for efficient ways of prolonging the therapeutic effect of biologics. With this cooperation agreement with XL-protein,” he continued, “we can now offer our customers feasibility studies for the production of PASylated variants of their therapeutic lead candidates. Thanks to our innovative ESETEC® technology, we can supply research quantities of PASylated active ingredients for pre-clinical studies within a couple of weeks.”

“After our positive experience with WACKER’s innovative secretion technology in producing PASylated therapeutic proteins,” said Prof. Arne Skerra, XL-protein’s co-founder and CEO, “we want to continue our collaboration in this field on a long-term basis. By partnering with Wacker Biotech, we can offer access to our innovative technology to a much wider circle of customers,” he emphasized. “As an experienced GMP manufacturer, WACKER can ensure that PASylated proteins are produced quickly and professionally.”

ESETEC®, WACKER’s patented E. coli-based secretion system, is a well-established technology for producing proteins and antibody fragments cost-efficiently. It is based on a patented strain of E.coli, K12, which is capable of secreting recombinant proteins in their native conformation directly into the culture broth during fermentation. This facilitates the subsequent 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. A number of biologics manufactured with ESETEC® are already being evaluated in preclinical and clinical trials.