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Microbial Technologies

Wacker Biotech offers innovative technologies for the efficient and cost-effective production of biologics, also including plasma half-life extension, if desired. According to the properties of the target protein, we recommend the most suitable expression strategy using ESETEC® and FOLDTEC® technologies.

With fast strain development and up to 3 times lower cost-of-goods, ESETEC® is the better alternative to mammalian systems for non-glycosylated proteins.

Similar to mammalian cells, the ESETEC® secretion strains can transfer proteins in their biologically active form across the outer cell membrane into the culture medium. ESETEC® is routinely used in biopharmaceutical manufacturing and has been scaled up to 4,500-liter fermentation batches. Secreted product titers can reach up to 14 g/l, depending on the protein of interest. More complex molecules such as single-domain antibodies and antibody fragments have been successfully produced with yields of up to 5 g/l. In any case, ESETEC® allows the fully functional molecule to be recovered from the culture broth, simplifies downstream purification and reduces manufacturing costs.

ESETEC® perfectly combines the benefits of secretion with the fast growth of microbial systems, enabling more cost- and time-efficient production of any non-glycosylated therapeutic protein. Based on cutting-edge process simulations, ESETEC® reduced the cost of goods by a factor of 3 compared to mammalian cells (assuming identical titers and process yields). The annual output of a dedicated 1,500-liter CHO facility was 30 kg compared to 111 kg using ESETEC® on the same scale. This significant advantage in productivity and costs is mainly driven by the shorter fermentation times and the fact that no viral depletion steps are needed.

More about ESETEC®

While Wacker Biotech’s own ESETEC® technology has proven highly efficient in producing soluble proteins via secretion, poorly soluble biologics form aggregated inclusion bodies within the cell. Here protein refolding is a key production stage for achieving the desired active properties. FOLDTEC® – our proprietary E. coli strains, complemented by our years of experience in refolding and a tailored screening approach – offers better efficacies, smaller folding volumes and fully scalable manufacturing processes, without the need for antibiotics or undesired phage components.

Folding optimization with FOLDTEC® can increase space / time / yields by 20-fold compared to state-of-the-art processes, as shown for production process of recombinant Thrombin.

More about FOLDTEC®

The LIBATEC® platform is suitable for a wide range of LMPs and fermentation regimes, allowing aerobic as well as specific anaerobic bacteria to be used. Wacker Biotech can set-up and run closed production systems (monoseptic processing), ensuring maximum culture purity and allowing specific routes of application, such as parenteral administration.

Our proven track record and experience in the LMP field allows us to meet the requirements of any project at every development phase. Our expertise extends to:

  • Replacing animal component-containing media
  • Maintaining cell viability throughout the production process by developing new freeze-drying cycles if necessary
  • Process characterization, process validation, clinical and commercial GMP manufacturing experience with LMPs

Following upstream and downstream processing, the bulk drug substance or drug product can be filled into vials or LYOGUARD® freeze-drying trays. Integrated drug product production, including lyophilization, provides a seamless manufacturing process, which may be critical in cases where there are limited hold times between cell harvesting, filling and storage. Wacker Biotech performs aseptic filling within the GMP fill-&-finish facility, which includes both formulation / preparation and the main filling area. It supports batch sizes up to 20,000 units (DIN 2R to 20R) and bulk lyophilization runs up to 65 L.

More about LIBATEC®

PASylation®

A major limitation of most biopharmaceutical proteins and peptides is their fast clearance from circulation via kidney filtration, which strongly hampers their efficacy in human therapy. In collaboration with the German company XL-protein GmbH, Wacker Biotech offers the production of PASylated biopharmaceuticals using ESETEC®. The great synergy results in high yields of PASylated biologics, with titers of several g/l. For example, PASylated Fabs can be produced with yields > 4 g/l.

Visit www.xl-protein.com to learn more about PASylation®.

PEGylation

Wacker Biotech has extensive expertise in the development and performance of the PEGylation step of biologics and synthetic peptides in our GMP facilities.

Wacker Biotech GmbH

Hans-Knöll-Strasse 3
07745 Jena
Germany
+49 3641 5348-0

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