In Jena, the Munich-based chemical group WACKER has enhanced its production facilities for biopharmaceuticals – also known as biologics – with new equipment. Furthermore, an inspection by the Brazilian health authority ANVISA assessing the site’s quality standards was a major success.
“In recent years, we have been continuously expanding our contract manufacturing capacity for biopharmaceuticals in Jena. The new, modern production equipment has further enhanced the site, making our company fit for the future,” explained Dr. Guido Seidel, managing director Operations of the wholly-owned WACKER subsidiary Wacker Biotech GmbH. The company invested €2.5 million in, among other things, a fully automated fermentation plant including a new bioreactor with a capacity of 350 liters, a new separator for efficiently isolating cells and a new GMP cell-bank suite. The suite enables independent cell-bank production and expands storage capacity for customer cell banks. Furthermore, analytical capacities were expanded with a new micro-biology laboratory and equipment for process and product characteri-zation. A modern eDMS system now enables the automatic handling of GMP documentation. As a result, Wacker Biotech’s Jena site is fully equipped to supply the fast-growing market for biologics. Future-oriented therapeutic agents now make up 25 percent of the global pharma-ceuticals market.
Another positive signal came with the recent visit from the Brazilian health authority ANVISA. After a five-day inspection of the production facility in April 2018, the ANVISA team confirmed that the Jena site complies with the Good Manufacturing Practice (GMP) principles and standards for the production of high-quality active ingredients. The health authority not only praised the GMP system itself, but also the outstanding organization and the professionalism of the WACKER employees.
The pre-approval inspection by ANVISA experts was arranged, because one of WACKER’s customers intends to market its cancer medication in Brazil. Wacker Biotech has been producing the active ingredient using a new, efficient, recombinant method since 2016. “We already received approval from the European Medicines Agency (EMA) in February 2016. With the successful ANVISA inspection, we now have further confirma-tion from a respected authority that we are able to provide our customers with outstanding products and efficient production processes,” empha-sized Dr. Susanne Leonhartsberger, managing director of Wacker Biotech GmbH. “This positive assessment makes Wacker Biotech an expert and certified partner for all customers who want to sell their products on the Brazilian market.”