The Microbial CDMO: Process Development and Manufacturing of Biologics

Wacker Biotech is “The Microbial CMO” — the 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 good manufacturing practice (GMP) manufacturing of biologics for clinical and commercial supply.

WACKER operates three state-of-the-art GMP facilities located in Europe (Germany and The 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 active pharmaceutical ingredients (APIs) and drug products (DPs). All three GMP production facilities are approved for commercial manufacturing by EMA, US FDA, and/or ANVISA.

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

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