Optimizing Production And De-Risking The Aseptic Drug-Filling Process With Real-Time, Viable Environmental Monitoring

By Nadiyra Walker, Head of Drug Product and Finished Goods Manufacturing; Henrik Herrmann, Director, Manufacturing, Sciences, and Technology Drug Product; and Anders Magnusson, Senior Engineer, Manufacturing Sciences and Technology Drug Product

In response to recent revisions to the European Commission’s Annex 1 regulatory framework, many contract development and manufacturing organizations (CDMOs) are scrambling to retrofit their drug product fill lines with innovative technology that meets new environmental monitoring (EM) standards. In contrast, consider the benefit of partnering with a CDMO whose drug product fill lines were built to fulfill Annex 1 standards and reduce potential contamination risks from the start.

A manufacturer who leverages real time, viable EM aligned with contamination control strategies (CCS) that are supported by quality risk management (QRM) systems, will manufacture safe products and meet regulatory compliance. Download the full article to gain insight into the impact of forming an end-to-end partnership with an Annex 1 compliant CDMO, where your biotherapeutic will be guided seamlessly from drug substance to drug product to finished goods manufacturing while making a long-term investment in high efficiency, quality, and product safety.