The event, coordinated by the Quality Innovation Group (QIG) and its Listen and Learn Focus Group (LLFG), brought together industry representatives, academics and regulators, including the European Commission, EDQM, FDA, PMDA and Swissmedic. The main conclusion was that sustainability can be integrated into pharmaceutical development and manufacturing through a gradual, science-based approach that preserves product quality, safety and efficacy.
Among the case studies presented, a consortium led by Imperial College London showed how digital tools combining techno-economic modelling and Life Cycle Assessment (LCA) can support evidence-based sustainability decisions. Researchers highlighted applications ranging from lentiviral vector production to monoclonal antibody manufacturing, while also pointing to the need for shared, non-confidential datasets to improve sustainability benchmarking.
Packaging and energy under the spotlight
Packaging emerged as another major focus area. Discussions covered the potential adoption of bio-based drop-in plastics, chemically identical to fossil-derived polymers, which could simplify regulatory implementation if supported by appropriate risk assessments. Participants also examined pathways to replace PVC blister packs, with industry groups proposing harmonised methods based on water vapour transmission rate (MVTR) to reduce the burden of product-specific stability studies.
Energy efficiency in manufacturing was another recurring theme. Data presented by GSK indicated that HVAC systems can account for up to 60% of a pharmaceutical site’s energy consumption. Adaptive HVAC technologies capable of adjusting airflow in real time could reduce energy use by more than 30% in Grade C and D environments, provided qualification and monitoring requirements can be adequately addressed.
Green chemistry and alternative methods
The Horizon Europe IMPACTIVE project showcased mechanochemistry as a viable alternative to solvent-intensive synthesis processes. One case study reported an 85% reduction in CO₂ emissions and environmental toxicity, together with lower production costs, through the use of twin-screw extrusion for nitrofurantoin manufacturing.
Additional discussions focused on predictive models for solvent recovery and recombinant alternatives to traditional bacterial endotoxin testing. Industry representatives highlighted recombinant Factor C (rFC) and recombinant Cascade Reagent (rCR) methods as more sustainable alternatives to tests relying on horseshoe crab-derived reagents.
Looking ahead, workshop participants agreed that sustainability should not become a standalone fourth regulatory pillar alongside quality, safety and efficacy. Instead, regulators and industry will continue working on targeted guidance, scientific alignment and international collaboration to facilitate the adoption of sustainable technologies across the pharmaceutical sector.
