As we develop new processes and evaluate new technologies it is important to consider sustainability and the environmental impact and how this can be improved. It is an area that we have been actively considering since the early days of BioSolve Process; when the focus of the industry was on the environmental impact of Single Use Technologies (SUT) compared to stainless steel-based processes. At that time, using BioSolve Process & working with Lindsey Leveen et al from Genentech[1] we were able to evaluate carbon footprint taking account of facility size, water consumption, energy use from all process steps. In this case, SUT had a lower carbon footprint which improves their sustainability metrics.
Later, in two studies[2],[3] carried out over several years with GE Healthcare, BioSolve Process provided resource usage and key utility data to input into Life Cycle Analysis exercises. These analyses were based on ISO standard approaches. This work provided detailed insights into the environmental impact of SUT for Monoclonal Antibodies and AAV manufacturing processes.
Our user community provides feedback on improvements to BioSolve Process, and Jack Gavin (Director, Environmental Sustainability at Merck) suggested to us that we should consider including a Process Mass Intensity Index (PMI) measure in BioSolve Process. The methodology was developed by the American Chemical Society (ACS)[4] in 2011 to benchmark and quantify improvements towards greener manufacturing processes. Initially focused on chemical syntheses, the PMI evaluates the quantity of all materials that must be utilized to make the desired product. We worked with Jack and the ACS working group to incorporate this methodology into BioSolve Process Version 7 giving the Biopharm community for the first time a sustainability metric to rapidly assess process and technology options.
We are now seeing our user community using the PMI measure to provide a quick measure of environmental impact when assessing new technologies. In a recent paper[5], the impact of continuous manufacturing from both an ecological and an economic perspective was modelled, using Biosolve Process. The authors compared two antibody production capacities and a fixed bioreactor volume of 1000 L. They were able to demonstrate that significant amount of water can be saved in downstream processing when using SUT. Overall economic and ecological impact is governed by the product titre and there is a good economic case for continuous integrated biomanufacturing. However, perfusion has a higher environmental PMI as a result of higher water consumption compared to fed-batch.
BioSolve Process will continue to support the Biopharm community in providing insights into the environmental impact of manufacturing processes and supply chains. To this end we will be enhancing the capabilities in future releases focussing on clean room energy requirements. If there is something you would like to consider please contact me at info@biopharmservices.com.
[1] Biopharm International November 2, 2008, The Environmental Impact of Disposable Technologies by Andrew Sinclair, Lindsay Leveen, Miriam Monge, Janice Lim, Stacey Cox http://www.iqpc.com/media/7763/11363.pdf
[2] Journal of Cleaner Production 41 (2013) 150e162. An environmental life cycle assessment comparison of single-use and conventional process technology for the production of monoclonal antibodies. Matthew Pietrzykowski, William Flanagan, Vincent Pizzi, Andrew Brown, Andrew Sinclair, Miriam Monge https://www.sciencedirect.com/science/article/pii/S0959652612005197
[3] https://www.gelifesciences.com/en/us/solutions/bioprocessing/knowledge-center/single-use-and-sustainability 2017, Single-use technology and sustainability: quantifying the environmental impact in biologic manufacturing
[4] https://www.acs.org/content/acs/en/greenchemistry/research-innovation/tools-for-green-chemistry.html
[5] Journal of Biotechnology 308 (2020) 87–95; Economics and ecology: Modelling of continuous primary recovery and capture scenarios for recombinant antibody production A.L. Cataldo, D. Burgstaller, G. Hribar, A. Jungbauer, P. Satzer https://www.sciencedirect.com/science/article/pii/S0168165619309290
