- WACKER invested €2.5 million in new biopharmaceutical production equipment in Jena.
- The investment includes a 350-liter bioreactor, a new separator, and a GMP cell-bank suite.
- ANVISA's April 2018 inspection confirmed compliance with GMP standards.
- Wacker Biotech has been producing a cancer medication's active ingredient since 2016.
Investment in Biopharmaceutical Production
WACKER has invested €2.5 million to enhance its biopharmaceutical production facilities in Jena. The investment includes a fully automated fermentation plant with a 350-liter bioreactor, a new separator for cell isolation, and a GMP cell-bank suite. This suite allows for independent cell-bank production and increased storage capacity for customer cell banks. Additionally, analytical capacities have been expanded with a new microbiology laboratory and equipment for process and product characterization.
ANVISA Inspection
In April 2018, the Brazilian health authority ANVISA conducted a five-day inspection of the Jena site. The inspection confirmed that the facility complies with Good Manufacturing Practice (GMP) standards for producing high-quality active ingredients. ANVISA praised the GMP system, organization, and professionalism of WACKER employees.
Market Expansion
The ANVISA inspection was arranged because one of WACKER’s customers plans to market its cancer medication in Brazil. Wacker Biotech has been producing the active ingredient for this medication using a recombinant method since 2016. The site had already received approval from the European Medicines Agency (EMA) in February 2016. The successful ANVISA inspection further validates WACKER’s capability to provide high-quality products and efficient production processes, making it a certified partner for customers targeting the Brazilian market.
