Full-service contract manufacturer of biopharmaceutical proteins, Wacker Biotech, has obtained US Food and Drug Administration (FDA) approval to manufacture reteplase — the active ingredient in the drug Retavase.
Approval
Retavase, a thrombolysis medication which will be marketed by the pharmaceutical company Chiesi, was recently approved by the FDA for the treatment of acute myocardial infarction in adults.
Successful transference and implementation of the entire manufacturing process for reteplase to a GMP site in Germany has already been achieved by Wacker Biotech in agreement with the original manufacturer of the medication, Roche. Additionally, the company has obtained approval from the European Medicines Agency (EMA) in 2012.
Approval by the FDA for the manufacture of the ingredient was achieved three months after the agency inspected the German site.
“We are very pleased with the FDA approval of Chiesi’s product Retavase for the US market. This allows us, as a contract manufacturer, to contribute to the treatment of serious illnesses such as a heart attack,” said Dr Susanne Leonhartsberger, managing director of Wacker Biotech. “I am very proud of the entire WACKER team that spent years establishing and implementing the required production process at our plant and has now achieved FDA approval for manufacturing, too. This confirms that our plants and processes are fully compliant with the most stringent of requirements. All of our customers can profit from this extensive expertise and know-how — from generating the cell line, to the transfer and optimization of existing manufacturing processes, to commercial market supply.”
“This approval represents a significant milestone in Chiesi’s work to bring Retavase back to the US market,” added Alan Roberts, senior vice president, Scientific Affairs for Chiesi USA. “WACKER is a proven leader in microbial technology. The collaborative effort and partnership have been outstanding.”