Wacker, a Munich, Germany-based chemical company, has expanded its biologics production facilities in Jena, Germany, with a new microbiology laboratory and equipment for process and product characterization.

“In recent years, we have been continuously expanding our contract manufacturing capacity for biopharmaceuticals in Jena,” said Dr. Guido Seidel, Managing Director, Operations, of Wacker Biotech GmbH, a wholly owned Wacker subsidiary and contract manufacturer of biopharmaceutical proteins based on microbial systems, in a September 13, 2018 company statement. “The new, modern production equipment has further enhanced the site, making our company fit for the future.”

The company invested EUR 2.5 million ($2.9 million) in a fully automated fermentation plant, including a new bioreactor with a capacity of 350 liters, a new separator for isolating cells, and a new GMP cell-bank suite. The suite enables independent cell-bank production and expands storage capacity for customer cell banks.

The site also passed an inspection by the Brazilian national health surveillance agency, Agência Nacional de Vigilância Sanitária (ANVISA), which assessed the site’s quality standards. The inspection by ANVISA experts was arranged because one of Wacker’s customers intends to market its cancer medication in Brazil.

After a five-day inspection of the production facility, the ANVISA team confirmed the Jena, Germany site complies with GMP principles and standards for producing high-quality active ingredients. Wacker also received approval from the European Medicines Agency in February 2016.

Source: Wacker