Wacker Biotech B.V.

With the acquisition of SynCo Bio Partners B.V. in Amsterdam, the Netherlands, in 2018, WACKER strengthened its pharmaceutical protein CDMO business and expanded its portfolio – an important step to keep pace with the rapidly growing biologics market. Wacker Biotech B.V. is a full-service contract manufacturer of live microbial products and biopharmaceutical proteins based on microbial systems as well as RNA-based nucleic acid medicines. It has special expertise in conjugation such as PEGylation.

The site’s history began in 1989 with the founding of EuroCetus B.V. by the US Cetus Corporation, targeting commercial production of the cancer drug ProLeukin II in Europe. Shortly after approval for the active was obtained in 1992, the company was taken over by Chiron Corporation and renamed Chiron B.V. After Novartis acquired Chiron Corporation in 2000, SynCo Bio Partners B.V. was spun off as an independent full-service contract manufacturer. WACKER then took over 18 years later.

Some 180 employees work at the Amsterdam site today. The plant consists of two GMP stainless steel fermentation lines (350 L and 1500 L), a 250 L single-use bioreactor and new facilities for RNA in vitro transcription (IVT) and lipid nanoparticle formulation. Additionally, the Amsterdam site has a lyophilization facility, where active ingredient solutions can be freeze-dried. This often improves their stability, i.e., their shelf life. Amsterdam’s production lines have a combined fermenter volume for pharmaceutical actives of some 2,000 liters.

A unique feature of the Amsterdam site is expertise in the production of live biotherapeutic products and other live microbial products. These represent a promising new class of actives, offering innovative treatments for serious illnesses and new vaccines against diseases such as cholera. To this end, the site has production rooms that are categorized as BioSafety Level 2 (BSL 2) and comply with the highest cleanroom classification – Class A. This means that there must be only very few organisms in each cubic meter of air, and there are extra precautions taken to work with materials presenting potential biohazards.