Our GMP plants in Jena and Halle provide a complete range of services for the development and manufacture of biopharmaceuticals. Production is based on microbial systems, for example FOLDTEC® E.coli protein refolding technology, ESETEC® E.coli secretion technology or a microbial system selected by customer. Based on these technologies, we produce biopharmaceuticals for applications ranging from clinical test samples to commercial market supply. Two manufacturing lines with 300-liter and 1,500-liter fermentation vessels and matching DSP scales are available to serve your production needs. We use our extensive experience to expertly guide you through the validation of your process.
Wacker Biotech GmbH holds certificates from the relevant authorities for its GMP-compliant production of recombinant proteins and follows the ICH Q7A guidelines for GMP-compliant production of active pharmaceutical ingredients (APIs). Our quality systems are continuously assessed by a combination of internal, customer and official audits.
High quality standards are our maxim. With years of experience in process technology and GMP, our experts are highly committed to transitioning your product from development through to commercial success.
Since 2012, the facility in Halle is EMA- und FDA-inspected for the commercial production of Reteplase (trade names Rapilysin®, Retavase®), a thrombolytic drug that is indicated to treat acute myocardial infarction. Very recently, the Jena plant received EMA approval for manufacturing of the approved product Spectrila®, a recombinant L-asparaginase for treatment of childhood leukaemia.