Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with more than 20 years of experience in microbial systems. We offer proprietary technologies (ESETEC^®, DENSETEC^®) that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust and highly efficient processes and GMP-compliant manufacturing for clinical trials and commercial supply. We opened recently a new process-development unit to optimize the entire process-development chain, from gene to purified protein. A second extension at the Jena site came on full stream in March 2010 after a multimillion investment. We doubled the production area in the existing GMP plant and added a brand new downstream processing suite.

Services

We work in close collaboration with our customers. Projects are managed by dedicated project managers supported by cross-departmental teams. Depending on our customers’ requirements, we have the flexibility to perform the whole process, or transfer projects at various stages. Wacker Biotech’s services comprise the full range, from construction and optimization of host–vector systems to filling of the bulk API. Construction and characterization of master and working cell banks, process development in fermentation and downstream processing, and GMP-manufacturing are accompanied by a quality control department equipped with a broad range of analytical methods.

Manufacturing: Wacker Biotech operates a CGMP multiproduct facility accompanied by process development laboratories that reflect the equipment of the GMP facility and high-standard analytical laboratories.

• EMA/FDA-compliant manufacturing
• 20–300 L process scales (further expansion to 1,500 L planned)
• DENSETEC^®: proprietary technology for high–cell-density fermentation
• ESETEC^®: proprietary Escherichia coli–based secretion technology for high-yield recovery of correctly folded proteins from culture broth
• Class 100,000 suites for fermentation and for harvest and primary recovery
• Class 10,000 downstream processing and purification suite
• Class 100,000 media and buffer preparation area.

Cost-Saving Proprietary Technologies: It is our aim to offer customers added value in all aspects. Therefore, we also provide them with technologies that reflect our focus on microbial-derived biopharmaceuticals.

Our customers can take advantage of an innovative and highly efficient ESETEC^®E. coli expression technology that results in high-yield secretion of recombinant proteins in native conformation into the culture broth. It comprises an engineered E. coli K12–derived host strain, optimized vectors, and a toolbox of helper proteins that are co-expressed with the protein of interest to improve secretion. Protein titers >10 g/L have been achieved. Furthermore, Wacker Biotech holds IP rights for a high–cell-density fermentation technology (DENSETEC^®) that allows optimal volumetric productivity in robust and highly reproducible fermentation regimes. Very high product yields have been reached in customer projects (>10 g/L).

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 pharma 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.

Author Details
Dr. Silvana Di Cesare is business development manager at Wacker Biotech GmbH, Hans Knoell Straße 3, 07743 Jena, Germany; silvana.dicesare@wacker.com, www.wacker.com/biologics.