Integrating Eco-Design in Bioprocess Development
BioSolve ProcessTM
Integrating Eco-Design in Bioprocess Development: A Pathway to Economic Sustainability
In recent years, the discussion surrounding environmental sustainability has grown more intense, focusing on reducing greenhouse gas (GHG) emissions.
The push towards sustainability is not just a trend; it’s a crucial step in combating climate change and preserving our planet for future generations. Every sector, including the healthcare and pharmaceutical industries, which account for 4.4% of global net emissions, is called to contribute. However, reducing the environmental impact of the biopharmaceutical industry presents unique and complex challenges, especially during early process development.
Today, the metric to address these challenges to guide eco-efficient bioprocess design is Process Mass Intensity (PMI). However, PMI measures the total mass efficiency and doesn’t account for the energy demands of production, which is a significant oversight.
At Biopharm Services, we have recognized the need for BioSolve ProcessTM to predict sustainability metrics accurately.
Client feedback has helped identify those metrics that are important to users.
We launched a version of BioSolve ProcessTM that can predict Total Facility Energy usage, GWP, and economics based on limited small-scale process information seen in early development.
These digital models are tools that bridge the gap between environmental goals and process development, optimizing processes for reduced GHG emissions and costs. See the attached table comparing predictions with published data.
With little published data, we rely on feedback from our industrial partners and support our client’s participation in the NIIMBL Process Intensification Program sustainability team. Over the past three years, NIIMBL members have been using BioSolve ProcessTM to evaluate the environmental impact of process intensification. They have provided feedback to enhance software accuracy and compared the output to actual facilities.
BioSolve ProcessTM ability to estimate the process’s total energy requirements opens new opportunities to address economics and environmental impact all in one package.
In the example shown in the figure, we compare mAb manufacture using three different technologies over a range of capacities. This provides valuable insights into key drivers and, through sensitivity analysis, evaluates the impact of titer, recoveries, etc. This allows users to target improvements by assessing the effects of intensification strategies, closed processing, optimization of cleanroom operation, evaluation of the impact of WFI generation options, and scale on the process’s cost and environmental impact.
BioSolve ProcessTM software contribution to understanding cost and sustainability in early process development represents a significant step towards ensuring our industries’ sustainability for our planet’s health.
The pharmaceutical industry’s efforts to reduce its environmental impact through the adoption of innovative methodologies and technologies are a testament to the broader commitment required from all sectors to achieve the ambitious goals set by the Paris Agreement.
- Karliner, J., Slotterback, S., Boyd, R., Ashby, B., Steele, K., & Wang, J. (2020). Health care’s climate footprint: The health sector contribution and opportunities for action. European Journal of Public Health, 30 (Supplement_5). https://doi.org/10.1093/eurpub/ckaa165.843
- Data used for the comparison table comes from Budzinski K, Constable D, D’Aquila D, Smith P, Madabhushi S, Whiting A, et al. Streamlined Life Cycle Assessment of Single Use Technologies in Biopharmaceutical Manufacture. N Biotechnol 2022; 68:28-36,
- NIIMBL is a public-private partnership focused on advancing biopharmaceutical manufacturing, solving industry challenges, and developing the skilled workforce of the future. https://www.niimbl.org/projects-programs/process-intensification/#:~:text=Develop%20decision%20tools%20and%20models%20that
