- Polpharma Biologics’ Duchnice facility has received EMA approval as a commercial manufacturing site.
- The site is now authorised for drug substance manufacturing and testing of natalizumab.
Polpharma Biologics has confirmed that its mammalian cell culture facility in Duchnice has been approved by the European Medicines Agency (EMA) as a commercial manufacturing site.
The approval adds Duchnice to the company’s network of authorised locations for drug substance manufacturing and testing. It specifically covers natalizumab, a biologic used in patient treatment.
According to the company, this represents a major step in its biomanufacturing activities and highlights the expertise and commitment of its teams. The development also reflects collaboration with Sandoz.
“This achievement marks a major step forward in our biomanufacturing journey and demonstrates the strength, expertise, and commitment of our teams,” the company stated.
