Scale Up on Efficiency in Biologics Contract Manufacturing

View PDF



Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with over 20 years of experience in microbial systems. Our customers benefit from a comprehensive service for the development of robust and highly efficient production processes and GMP-compliant manufacturing for clinical trials and commercial supply.

Service

Wacker Biotech’s services cover the whole process chain: from construction and optimization of host/vector systems to delivery of the bulk API. A well-equipped quality control department supports characterization of master and working cell banks and development of fermentation and downstream processing as well as GMP-manufacturing. Apart from routine lot-release testing, the quality control department also performs ICH-compliant stability studies. For more flexibility, we can develop the entire production process and analytical methods or transfer projects at each stage.



Projects are managed by dedicated project managers assigned to each project. They coordinate cross-departmental project teams and ensure that the project is executed as planned. These project managers are the customers’ primary points of contact.

Manufacturing

Wacker Biotech operates a GMP multiproduct facility in Jena, Germany:

  • EMA- and FDA-compliant manufacturing

  • Process scales from 20 L to 300 L (with further expansion to 1500 L planned)

  • DENSETEC® proprietary technology for high-cell-density fermentation

  • ESETEC® proprietary E. coli-based secretion technology

  • Class 100,000 suite for fermentation

  • Class 100,000 suite for harvest and primary recovery

  • Class 10,000 downstream processing and purification suite

  • Class 100,000 media and buffer preparation area

  • GMP manufacturing and process development equipment is highly aligned to ensure smooth process scale-up.

Cost-Saving Proprietary Technologies

To enrich its contract biomanufacturing activities, Wacker Biotech also offers technologies that reduce the overall cost of goods and help developing novel biopharmaceuticals.

The innovative and highly efficient ESETEC® Escherichia coli expression technology results in high-yield secretion of recombinant proteins in native conformation into the culture broth. With ESETEC®, several low-yield process steps (e.g., refolding) are no longer necessary, so downstream processing becomes much easier and more cost effective.

Wacker Biotech also holds IP rights for DENSETEC®, a high-cell density fermentation technology. DENSETEC® allows optimal volumetric productivity in robust and highly reproducible fermentation regimes. Product yields >10 g/L have already been reached.

PASylation® is an innovative technology from the German company XL-protein GmbH, which enables the development of biopharmaceuticals with extended plasma half-life. WACKER offers access to this technology for the production of PASylated proteins using the ESETEC® secretion system. For PASylated Fabs, yields of 4.3 g/L have been achieved with ESETEC®.

Regulatory Affairs and Track Record

Our quality assurance system is based on the ICH Guidelines and European and US regulatory requirements and has been approved in numerous inspections by authorities and in client audits. Wacker Biotech holds a manufacturing license for the production of recombinant proteins and has experience with a large number of pharmaceutical and biotechnology companies located in Europe and the United States. Wacker Biotech has a strong track record and experience from clinical phase 1 to phase 3.

About the Author

Author Details
Dr. Silvana Di Cesare is Business Development Manager at Wacker Biotech GmbH, Hans Knoell Str. 3, 07743 Jena, Germany; silvana. dicesare@wacker.com, www.wacker.com/biologics.

Leave a Reply