2024 | January / February 2024

Navigating the chemical revolution: A roadmap for sustainable and digitally-driven manufacturing

by cyb2025

ANDREW RUTTER
rutterdesign

ABSTRACT

This is a time of change for makers of chemicals; a mixture of political, economic, and ecosystem pressure is creating stresses on the way complex chemical products are made for society. News feeds provide a daily reminder of how climate change, growing resource scarcity, and supply issues are challenging and creating shortages in the supply of important products like medicines….

This is a time of change for makers of chemicals; a mixture of political, economic, and ecosystem pressure is creating stresses on the way complex chemical products are made for society. News feeds provide a daily reminder of how climate change, growing resource scarcity, and supply issues are challenging and creating shortages in the supply of important products like medicines.

 

My personal belief is that manufacturing will be radically different in 30 years’ time. We will have made significant progress to address the imbalances in our ecosystems. First, we will have reduced consumption demand by embracing products that are durable and in medicine by moving towards cures. Where we do consume, production will be increasing circular with integrated up and down cycling common place.

 

Second, production will be at worst regionalised but typically localised to the city scale, reducing transportation, and becoming responsive to demand. The use of AI in a future state that is more responsive is described by Dr Anil Kane in his commentary article, “Artificial Intelligence (AI) in Pharma Supply Chain, Logistics, and more”. Further, automation of factories will reduce the energy consumption of the production space and increase the precision of manufacture (another source of waste).

 

This seems like science fiction, but we see many technological advances emerging that may provide the solutions. Many of the articles in this issue do just this, they describe elements of a new manufacturing landscape where digital technologies support the design and operation of future processes.

Why is this important? In a highly regulated environment for complex chemical entities, the societal outcomes of sustainable manufacture require an increase in productivity to support the economic investment required to transition to new supply chains. Further, our expectations for safety and efficacy of these molecules, be they actors that enter the food chain or our bodies, will not lessen.

 

Digital technologies are needed to support speed and productivity in exploring the design space (to get a product and process to market in time), driving efficiency (affordability) in the supply chain. Rob Crook, Director and Jean-Baptiste Vendeville of CatSci ltd consider the positive impact of modelling to support better chemical routes for manufacture of high potency molecules, like ADCs. In a similar space, Cenk Ündey, Head of Data and Digital, Pharmaceutical Technical Development, Genentech, Roche describes the wider organisational workflows that link the capture of data to a network of computational and machine learning modelling tools to enable speed to patients, efficiency in operations with increased productivity.

 

As businesses drive forward Sustainability and Net Zero agendas, digital tools designed to bring transparency will also become foundational. Supply chains for complex molecules be they advanced chemical intermediates, small molecule drug substances, biopharmaceutical, gene therapies or drug constructs will need to be reordered to take advantage of new feedstocks, advance catalysts, and tie into broader up and down cycling networks that link multiple manufacturers. This will need frameworks and standards to make the optimal decisions in a world of complex choice of chemical synthesis route. Peter Saling, Director Sustainability Methods at BASF shares the work of the TfS Scope 3 GHG emissions programme in setting a better carbon accounting methodology to support decisions on sustainability. Further, Dr. Eduard Cayón of REPHINE outlines how Digitalisation of manufacturing operations and associated quality control have become competitive imperatives.

 

Finally, there is the question of affordability. Manufacturers making a product that is valuable to society would always wish that it helps as many people as possible. In this issue Kai Lipinski explores the impact of technology in enhancing affordability for gene therapies. This illustrates a key point: that regulatory frameworks need to evolve to support and incentivise positive change.

 

There is much to do to change manufacture. It feels the component parts of the solution are gaining momentum.

ABOUT THE AUTHOR

Andrew Rutter is a Fellow of the Royal Academy of Engineers and an independent consultant with expertise in the application of Advanced Manufacturing Technologies, particularly in Medicine Manufacture. A Chemical Engineer by training, he spent 20 years developing new manufacturing processes for GSK. Recognising his expertise in Continuous Manufacture of Active Ingredients he was appointed as EFPIA representative, to the Expert Working Group for ICH Q13, Guidance on Continuous Manufacture. Prior to working in Pharmaceutical manufacture he worked on Large Scale Petrochemical processes, and Process Economics for IBM. He currently advises many major Pharma companies, and Government organisations.

Login