The Microbial CMO: Process Development and Manufacturing of Biologics

Wacker Biotech is “The Microbial CMO” — the partner of choice for contract manufacturing of therapeutic proteins using microbial hosts. Our service portfolio covers molecular biology, process and analytical development, and the GMP production of biologics for clinical trials and commercial supply. Founded in 1999 as a spin-off from the Hans-Knöll Institute in Jena, we are a 100% subsidiary of Wacker Chemie AG since 2005.

The sites in Jena and Halle provide a complete range of services for the development and GMP-compliant manufacture of biopharmaceuticals. Two manufacturing lines with 300-L and 1,500-L fermentation vessels and matching DSP scales are available to suit all possible customers’ needs.

WACKER holds biomanufacturing certificates from the relevant authorities for both sites and follows the ICH Q7A guidelines for GMP-compliant production of biologics. The facility in Halle has been EMA and FDA approved for the commercial production of Reteplase (trade names Rapilysin® and Retavase®), a thrombolytic drug that is indicated to treat acute myocardial infarction. In 2016, the Jena plant received EMA approval for manufacturing of the approved product Spectrila®, a recombinant l-asparaginase for treatment of childhood leukemia.

WACKER rounds out its offering with outstanding Escherichia coli technologies that can significantly increase the bioprocess efficiency and thus reduce cost of goods.

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