Scale Up on Efficiency in Biologics Contract Manufacturing July 2008

Wacker Biotech has a 20-year track record in manufacturing microbial-derived biopharmaceuticals, giving us a deep understanding of such products and of our customers’ needs. We provide comprehensive contract-manufacturing services and proprietary technologies that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust, highly efficient, and readily scalable processes and GMP-compliant manufacturing for clinical trials and commercial supply.

Service

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 of production strains, 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.

cGMP manufacturing is accompanied by process development laboratories, reflecting the equipment in the GMP facility and high-standard analytical laboratories.

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 E. coli expression technology that results in high-yield secretion of recombinant proteins in native conformation into the culture broth. It comprises a special E. coli K12-based host strain and high-expression plasmids. Furthermore, Wacker Biotech holds IP rights for a high-cell density fermentation technology. It allows optimal volumetric productivity in robust and highly reproducible fermentation regimes. Very high product yields have been reached in customer projects (>10 g/L).

Efficient purification processes are the result of systematic selection of the chromatography media, specification of chromatography parameters in direct liaison with the process development analytical team, and our employees’ experience. ()

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 phase 1 to phase 3 clinical supplies. Commercial development and production of recombinant proteins has been the company’s focus since 1999. Wacker Biotech is a 100% subsidiary of the WACKER Group, which generated sales of €3.781 billion in 2007.