The biopharmaceutical industry’s core mission is the uninterrupted delivery of high-quality, efficacious drugs. At the same time, the industry is under pressure to make production as sustainable as possible.

To achieve these dual goals, biopharmaceutical companies must be willing to use innovative bioprocessing technologies and embrace the human-centric ideas of the emerging “Industry 5.0” model, according to new research.

The study, by a team at the Sargent Centre for Process Systems Engineering at Imperial College London in the U.K., examined industry efforts to move toward net zero, socially sustainable, and eco-efficient operations.

Novel digital tool development

One key finding is that, although it is hard to quantify process sustainability at present, new digital tools are being developed to help drug companies better understand their environmental impact.

“Currently, it is challenging to pinpoint more or less sustainable products if we consider that processes are product-specific and also differ on a company-basis,” according to lead author Miriam Sarkis, a doctoral student. “The good news is that model-based tools to answer this question exist and have been developed to tackle case studies for other industries.”

“With the recent growing interest in sustainability within biopharma, we are surely going to see a larger volume of comparative studies screen production pathways for a range of products.”

Quantification difficulties aside, the researchers also identified some other common challenges. In upstream processes, for example, the major issue is the large amount of water needed for cell cultivation. For downstream processes, the requirement for resins and solvents is the biggest difficulty from a sustainability standpoint.

“In addition to this,” said Sarkis, “if manufacturing relies on stainless steel equipment additional water is required to sterilize and clean equipment after each batch. Switching to single-use equipment has been shown to help reduce the water requirements for inter-batch cleaning. The industry has seen an increasing uptake of single-use technologies driven by a need to build more flexible and easily scalable facilities.”

Continuous manufacturing

Another finding was that growing industry interest in new production models is, in part, driven by a desire to make processes more sustainable.

“Process intensification through continuous manufacturing helps lower costs and environmental footprint per unit product and is surely the sustainable way forward for the sector,” Cleo Kontoravdi, PhD, professor and co-author of the paper, told GEN.

But companies looking to make processes more sustainable through intensification still face some technical and regulatory challenges.

“At regulatory level, there seems to be a resistance towards switching currently established batch and fed-batch manufacturing to novel continuous technologies. Regulators also expect manufacturers to develop tailored control strategies to monitor their processes and ensure product quality. The sector still has a long way to go before developing truly end-to-end control strategies,” explained Kontoravdi.

“Model-based control solutions are available for a variety of fed-batch upstream bioprocesses; however, these are highly process specific, and the market currently lacks universal and easy-to-use model-predictive control (MPC) options for advanced bioprocess control for an integration of upstream and downstream processes.”

These issues are likely to encourage the adoption of automation and artificial intelligence driven technologies, noted Sarkis.

“Robust process performance can increase process efficiency and support manufacturers in meeting quality, economic and environmental objectives. In this space, automated bioprocessing provides numerous advantages, including improved process control, enhanced product quality, reduced variability, increased efficiency, and cost savings,” she said.

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