Biologics are a growing sector of the pharmaceutical industry and have become a significant portion of many companies’ pipelines. The BioPharma Focus group seeks to improve the environmental footprint of biologics development and manufacture through the adaptation and implementation of green chemistry and engineering principles.
Incorporating green chemistry into the biopharma industry
Developing Metrics to Measure Environmental Impact
The team has developed a process mass intensity (PMI) tool specifically for biologics which catalogs the amount of water, raw material, and consumable used per kg of product produced. Member companies participated in a PMI benchmark activity resulting in a manuscript published at New Biotechnology. The team is expanding the concept and have created a Cleaning Mass Intensity (CMI) metric which catalogs the amount of water and chemicals used to clean stainless steel equipment. Companies are currently using the CMI tool to benchmark cleaning of bioreactors, media/buffer tanks and product tanks.
Single Use Technology
- The team surveyed member companies to better understand current the end-of-life practices for single use technology.
- The team is working with Environmental Resources Management (ERM) to perform an LCA on the use-phase of single use technology to highlight environmental hot spots.
Updated: September 2021
- PMI benchmark and publication
- LCA for Bioprocess w Single Use Components
- Excel LCA tool drafted
- Manuscript drafted (response to reviewers underway)
- Finalize LCA Publication and Excel LCA tool
- Consider publishing Cleaning Data—water consumption; cleaning agents, e.g., Phosphorus. Determine if assessing chemicals is valuable.
- ACS Analytical guest speaker (October) to determine relevance & gaps for BioProcess Analytical Methods
- Redefine PMI for early process development
- Consider presenting at ACS BIOT
- Establish baseline of industry sustainability initiatives to inform Industry Strategy and opportunities for collaboration
- Integrate LCA tool with PMI—possibly Carbon Footprint
- Wastewater – testing, acceptable levels, issues; treatment options
- Procurement – evaluate bioprocess RM’s, feedstocks, supply chain PSCI?
- Digital Sustainability, e.g., digital twins (reduce actual experiments)
Publications & Presentations
Cataldo, A. L.; Sissolak, B.; Budzinski, K.; Shirokizawa, O.; Luchner, M.; Jungbauer, A.; Satzer, P. Water related impact of energy: Cost and carbon footprint analysis of water for biopharmaceuticals from tap to waste. Chem. Eng. Sci. 2020, 8, 100083. https://doi.org/10.1016/j.cesx.2020.100083
Introduction of a process mass intensity metric for biologics
Kristi Budzinski, Megan Blewis, Philip Dahlin, Daniel D’Aquila, Julia Esparza, Jack Gavin, Sa V. Ho, Clarice Hutchens, David Kahn, Stefan G. Koenig, Robert Kottmeier, Jeff Millard, Matt Snyder, Brad Stanard, Lixin Sun
Introduction of a process mass intensity metric for biologics, New Biotechnology, Volume 49, 2019, Pages 37-42, ISSN 1871-6784, https://doi.org/10.1016/j.nbt.2018.07.005.
Abstract: Biopharmaceuticals (or biologics), large molecule therapeutics typically produced using biotechnology, are a rapidly growing segment of the pharmaceutical market. As such, the environmental footprint of the production of these molecules is coming under scrutiny from various stakeholders such as healthcare providers, investors, and even employees. Process mass intensity (PMI), originally adopted for small molecules by the Green Chemistry Institute Pharmaceutical Roundtable, is a simple metric that can also be applied to evaluate the process efficiency of biopharmaceutical production. PMI for biologics is defined as the total mass input in kg of water, raw materials and consumables, required to make 1 kg of active pharmaceutical ingredient. Six large pharmaceutical companies participated in a benchmarking exercise to calculate the PMI for monoclonal antibody (mAb) production. On average, 7700 kg of input is required to produce 1 kg of mAb. Over 90% of the mass is due to water use, highlighting the water-intensive nature of biologics production.
ACS National Meeting in Orlando:
- Hosted ACS BIOT Frontiers in Sustainable Production session.
- Sponsored BIOT division coffee break
March, 2018 ACS National Meeting in New Orleans:
- Presented benchmark PMI data. GSK and Merck also presented on their respective green biopharma work.
- Sponsored BIOT division coffee break
Joint FDA/PDA Conference:
- Panel discussion on green chemistry for health authorities