I am a senior researcher in the Health Group at AIMPLAS, the Instituto Tecnológico del Plástico in Valencia, Spain. There I am responsible for leading the development of pharmaceutical dosage forms by hot melt extrusion, biocompatible materials for bone and tissue regeneration, and medical devices. Previously I was responsible for the nanomaterials Research group at AIMPLAS and I have extensive experience developing polymer formulations in a variety of contexts and applications including nanocomposites, fire retardants, biopolymers, natural fibers composites, and PVC.
I guess it might not seem immediately obvious why a centre specializing in plastics processing would be leading a project which is mostly about sustainably making, supplying and using pharmaceutical products, but for me, ETERNAL is a natural step forwards in AIMPLAS’s interests in demonstrating how innovative process options like hot melt extrusion can open up new possibilities for pharmaceutical manufacturers, enabling them to design and make high quality products whilst reducing process complexity and the environmental burden of traditional batchwise, solvent-based technologies.
ETERNAL is also a fantastic opportunity to work for an extended period with the diverse mixture of talents and perspectives represented in our sixteen-partner consortium. Our partnership includes large international-scale pharmaceutical manufacturers as well as innovative contract research, development and manufacturing organizations who make much of the chemistry and biochemistry in the pharma value-chain possible. Working alongside these end users are technology- and knowledge-driven business specializing in things like digital technology and process automation, environmental engineering, whole process design for sustainability, and scientific and regulatory affairs. Finally, we are fortunate to be able to draw upon the expertise of several academic and public sector research institutions in relevant areas such as Environmental and Ecotoxicity Assessment, Green Chemistry, Mechanochemistry and Standardization.
There is a huge amount of detailed work going on right across the project already but there are four main themes that all this work can be traced back to. First, Green Manufacturing: options like continuous manufacturing for Active Pharmaceutical Ingredients (APIs) and Drug Products, Mechanochemistry, solvent reduction, recycling, and replacement with greener alternatives, removal of impurities including potential carcinogens, and more energy-efficient process design and practice all feed into this. Secondly enabling Digital Transformation: digitization of work and information flows, Process Automation (PAT) for Quality by Design and continuous manufacturing, and harnessing AI and Digital Twin technologies for competitive and scalable production methods. Thirdly, we’ll be thinking about Safe Use and Disposal: how to make products intrinsically less environmentally harmful, building our understanding of ecotoxicity of current and new pharmaceuticals, and developing new ways to better capture impurities in wastewater streams. Finally, there is the human dimension of Social Awareness: working with everyone from regulators and public authorities around how legislation can be a lever for sustainable innovation, through to business decision makers, and medical practitioners and dispensers as influencers and supporters to the role of ordinary citizens in responsible use and disposal of drugs.
Well, practically speaking the project is organized into several work packages. At the heart of the project is the progression of a set of six case studies identified by our industrial partners as being relevant to their priorities and challenges around process sustainability. The multidisciplinary team involved in each case study has got together to identify technological approaches, innovation targets and to co-create a workplan appropriate to their identified challenge. Taken together the case studies give an excellent cross-section of the sorts of issues encountered right across the pharma industry in greening their manufacturing processes and products.
Alongside the progress and scale-up of the case studies from bench to demonstration, we are also looking to develop the enabling digital tools involved in many of them, as well as building a bigger picture of opportunities and barriers around digitalization of the European pharmaceutical industry. Smarter and better digital tools for process automation and digital twin approaches hold great potential especially when they are developed with regulatory compliance in mind, but so does streamlining data and information flows between organizations in the pharma value chain.
Finally, we are looking to contribute to generating new scientific knowledge on the environmental fate and eco-toxicological effects of pharmaceuticals, performing targeted studies assessing the toxicity of pharmaceuticals and their by-products to ecosystems, using mathematical models to predict their transport into and around the environment, collating monitoring data, and producing a roadmap to integrate new scientific knowledge into regulatory risk assessment. Ultimately this will allow us to target mitigations, modifications and management strategies towards a greener, more sustainable environment.
I can sense a coming green paradigm shift in the pharmaceutical industry.
ETERNAL will demonstrate that is possible to include different continuous process, PAT technologies and other improvements to obtain greener products. It is also necessary to increase the knowledge of practitioners about medicines and their impact upon the environment, but that will only be possible if the industry can provide specific and standardized data about sustainability. ETERNAL and our sister projects are working on different specific aspects of what is needed but in the same overall direction to make all of this real.
Moreover, there is a growing concern stemming from the presence of pharmaceutical residues that can enter the environment at all stages of their life cycle (via effluents from manufacturing, natural excretion, or improper disposal). ETERNAL will monitor all stages of the life cycle, ensuring that citizens can access safe, high quality and effective pharmaceuticals without the environment paying the price.
I hope that ETERNAL will be the start of the change.