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Microbial Technologies

Wacker Biotech offers innovative technologies for the efficient and cost-effective production of biologics, including live microbial products, vaccines and plasmid DNA. Via collaboration with XL protein, Wacker Biotech can offer unique solutions for 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.

The production site in San Diego is equipped with 30 L single-use bioreactors and 500 L stainless steel fermentation vessels, including continuous cell lysis. Corresponding primary recovery and downstream capabilities are available to suit various customer needs along the manufacturing path. Our team is highly experienced and has been manufacturing GMP-compliant pDNA since 2003 (more than 100 GMP batches released).

With strain development and up to three times lower cost of goods sold (COGS), ESETEC® is a 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 L fermentation batches. Secreted product titers can reach up to 14 g/L depending on the protein of interest. For more complex molecules, we created a new controlled product release technology based on decoupling the production phase from the release phase. In controlling the exposure time to overexpressed chaperones and isomerases in the periplasm, Wacker Biotech has succeeded in optimizing the folding step and maximizing the level of secretion, leading to the best possible results for each target protein. 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 process simulations, ESETEC® reduced the cost of goods by a factor of 3 compared to mammalian cells (assuming identical titers and process yields) due to the faster growth of E. coli. The annual output of a dedicated 1,500 L CHO system 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 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, supporting batch sizes up to 20,000 units (DIN 2R to 20R) and bulk lyophilization runs up to 65 L.

More about LIBATEC®

Our production sites are home to state-of-the-art biosafety level 1 (Halle, Jena) and 2 (Amsterdam) facilities, as well as an explosion-proof room (Amsterdam) for manufacturing vaccine products under ICH and GMP quality guidelines. Our stainless-steel fermenters range in capacity from 270 L to 1,500 L, and our single-use reactors can accommodate volumes of up to 250 L. Furthermore, at our site in Amsterdam, we operate a modern GMP fill-and-finish facility for aseptic filling operations of DIN 2R to 20R up to 20,000 vials per batch as well as bulk lyophilization up to 65 L. Wacker Biotech has produced and released more than 650 GMP vaccine batches for clinical (phase I to III) and commercial applications. We provide efficient solutions for customer-specific process development and process transfer, complemented by tailored analytics for quality control.

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: THE MICROBIAL CDMO Expands into the U.S.

Wacker Biotech GmbH

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

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