The Microbial CMO – Process Development and Manufacturing of Biologics

Wacker Biotech is “The Microbial CMO” — partner of choice for process development and contract manufacturing of biopharmaceuticals (proteins, vaccines, and live microbial products) using microbial hosts. WACKER’s integrated service portfolio covers molecular biology, process/analytical development, and GMP manufacturing of biologics for clinical and commercial supply.

WACKER operates three state-of-the-art GMP facilities located in Europe (Germany and Netherlands). Manufacturing lines with two 300-L and two 1,500-L stainless steel fermentation vessels, single-use fermentation lines, matching downstream processing scales and fill and finish capabilities are available to suit all possible customers’ needs (BSL 1 and 2).

WACKER holds biomanufacturing certificates from the relevant authorities for all 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.

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