EDUARD CAYÓN
VP Audit Services, Rephine Ltd, Barcelona, Spain

Abstract

As innovative biotech products and personalised therapies progress from lab-based scientific research to human clinical trials and full-scale production, companies are being forced to adapt their Quality processes. Dr. Eduard Cayón of Rephine/ TDV explains how reimagining Quality processes can help get these potentially expensive emerging therapies to market.

As the emphasis of new drug development gravitates away from chemical synthesis towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working.

Across all of this is the criticality of compliance with Good Manufacturing and Good Distribution Practice (GMP/GDP), and of a fit-for-purpose Quality system. Engineering or redesigning facilities without due consideration of what’s needed, of what may be superfluous, or of how systems and processes will be validated over time, could lead to costly remedial action and delays in getting important and premium new products to market.

Beyond adapting existing sites or engineering new facilities geared to modern drug production, biopharma companies also need to be more cost-conscious than ever before in the way they run and monitor their manufacturing and supply chain operations. That’s because of th ...