Proteins

With fast growth and up to three times lower cost of goods sold (COGS), ESETEC^® is a better alternative to mammalian systems for non-glycosylated proteins.

Like 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 over-expressed 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.

Wacker Biotech offers selection of the best ESETEC^® producer strain with high-throughput screening system. Up to 300 basis ESETEC^® strains and expression plasmid combinations can be screened for identification of the ideal producer strain for your product. (hier auf den Artikel verlinken)

While Wacker Biotech’s own ESETEC^® technology has proven highly efficient at 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 by the production process for recombinant thrombin.

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 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 of up to 20,000 units (DIN 2R to 20R) and bulk lyophilization runs of up to 65 L.

Our production sites are home to state-of-the-art biosafety levels 1 (Halle, Jena) and 2 (Amsterdam) facilities, as well as an explosion-proof room (Amsterdam) for manufacturing vaccine products to ICH and GMP quality guidelines. Our stainless-steel fermenter has a capacity of 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 up to 20,000 vials (DIN 2R to 20R) per batch as well as bulk lyophilization of up to 65 L. Wacker Biotech has produced and released more than 650 GMP vaccine batches for clinical (phases 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.