The upgrade adds a new 1,500-liter fermentation line and new cleanroom structures in an existing 270-liter fermentation line.  After a transition period, the new 1,500-liter line will replace an existing line of the same volume capacity.

Among other improvements, existing cleanrooms will be completely renovated and re-equipped with state-of-the-art equipment, while new utilities, such as water for injection, will be added.

The new projects are designed to help the CDMO prepare the Dutch site to produce new classes of actives such as pDNA and mRNA-based vaccines. The two nucleic acid-based actives classes are currently playing a role in the search for a vaccine against the SARS Cov-2 coronavirus.

The investment at Amsterdam is an “important step in our continued growth in its pharmaceutical business,” Susanne Leonhartsberger, head of Wacker Biosolutions, the group’s life-science division, said. Guido Seidel, head of the Biopharmaceuticals business line and managing director of Wacker Biotech, added that it also will strengthen the German player’s position as one of the leading contract manufacturers in the field of microbial production of biologics.

Acquiring the Dutch premises in 2018 effectively doubled Wacker’s biologics capacity. The portfolio was later expanded to take in vaccines (including polysaccharides) and live microbial products. The two fermentation lines manufacture microbial-derived biopharmaceuticals for clinical testing as well as commercial purposes.

The site’s single-use fermenters with a capacity of 250 liters, together with the ancillary equipment, offer additional manufacturing potential, while the sites service offering includes a fill-and-finish facility for filling and lyophilization.  This enables the complete manufacture of pharmaceuticals from the active agent to the filled product, the group said.

Wacker Biotech maintains three GMP-compliant, FDA- and EMA-certified production plants at its German sites in Jena and Halle as well as in Amsterdam.