Amsterdam
In addition to recombinant protein manufacturing, Wacker Biotech Amsterdam is the center of excellence for live microbial products, microbial and mRNA-based vaccines and fill & finish within the manufacturing network. The facility is certified to biosafety level 2.
Process transfer & development capabilities:
7 – 20 L glass, stirred-tank fermenters
GMP manufacturing:
250 L stirred single-use bioreactor, 1,500 L stainless-steel stirred-tank fermenter, dedicated purification lines
The site in Amsterdam has been a licensed manufacturing plant for active pharmaceutical ingredients and small volume parenterals (SVPs) since 1992. In 2016, the Amsterdam site received FDA approval for production of a cholera vaccine (trade name: VaxchoraTM) marketed by PaxVax.
In addition, the facility has been inspected and approved by several other international regulatory authorities, such as Korea's MFDS, Brazil's ANVISA and Health Canada. The site in Amsterdam is licensed by the Dutch authorities for the production of biopharmaceuticals for clinical use and market supply.