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Biopharma

Biologics are a growing sector of the pharmaceutical industry and have become a significant portion of many companies’ pipelines. The Roundtable seeks to improve the environmental footprint of biologics development and manufacture through the adaptation and implementation of green chemistry and engineering principles. To this end, the Roundtable 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. In addition, a Cleaning Mass Intensity(CMI) metric has been developed, that catalogs the amount of water and chemicals used to clean stainless steel equipment. Finally, the Roundtable is working to better understand the current end-of-life practices for single use technology.

Related Resources

Streamlined Life Cycle Assessment of Single Use Technologies in Biopharmaceutical Manufacture

Streamlined Life Cycle Assessment of Single Use Technologies in Biopharmaceutical Manufacture Budzinski, K.; Constable, D.; D’Aquila, D.; Smith, P.; Madabhushi, S.R.; Whiting, A.; Costelloe, T.; Collins, M. New. Biotech. 2022, 68, 28-36. https://doi.org/10.1016/j.nbt.2022.01.002

Introduction of a process mass intensity metric for biologics

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. New Biotechnology. 2019, 49, 37-42. DOI: 10.1016/j.nbt.2018.07.005.

Countercurrent Staged Diafiltration for Monoclonal Antibody Formulation

Andrew Zydney, Penn State, $50,000
“Countercurrent Staged Diafiltration for Monoclonal Antibody Formulation.”

Diafiltration of Monoclonal Antibody using pH Responsive Membrane with Positive Charge

Leo Choe Peng, Universiti Sains Malaysia, $16,000
“Diafiltration of Monoclonal Antibody using pH Responsive Membrane with Positive Charge.

Special Report: Toward Sustainable Engineering Practices in Biologics Manufacturing

Special Report: Toward Sustainable Engineering Practices in Biologics Manufacturing Kristen Brown, Kristi Budzinski, Sa Ho, Jeff Millard, Jeffrey Johnson, Phillip Dahlin, Barbara Owen, Robert Kottmeier. BioProcess International [Online]; 2015.