Contributed byChristiana Briddell, Communications and Outreach Manager, Green Chemistry Institute®
Accounting for 20% of today’s global pharmaceutical market, biopharmaceuticals have emerged as a significant share of pharmaceutical research and development. Responding to this trend, the ACS GCI Pharmaceutical Roundtable (GCIPR) formed a biopharma focus group in 2012 to incorporate the principles of green chemistry and engineering into biopharmaceutical development and manufacturing. Active participants in the focus group include Genentech, Pfizer, Amgen, Johnson & Johnson, Merck Sharp & Dohme, Sanofi, Eli Lilly and Glaxo-Smith Kline.
Biologics production has an entirely different set of environmental challenges than traditional small molecule chemistry. The focus group has identified three main challenges—water, energy and solid waste—detailed in a special report published last year in BioProcess International, “Towards Sustainable Engineering Practices in Biologics Manufacturing.”
The Roundtable conducted preliminary bioprocess benchmarking among member companies using the Process Mass Intensity (PMI) metric applied to monoclonal antibodies, mAbs, as mAbs represent one of the fastest growing classes of biologics. They are used in over 40 FDA-approved therapies for treating diseases like cancer, autoimmune diseases, transplant rejection and others. The benchmarking exercise showed that of the total mass used, water accounts for 87%. In addition, 64% of that water is used in chromatography. Although water is in itself is often considered “green”, the sheer quantity used presents important environmental considerations.
To begin to address this issue the Roundtable issued a request for grant proposals to optimize water use in downstream processing steps for monoclonal antibody production. The winners of this grant are Professor Andrew Zydney from the Department of Chemical Engineering at Penn State and Professor Leo Choe Peng from the School of Chemical Engineering at the Universiti Sains Malaysia.
Professor Zydney’s proposal is titled, “Countercurrent Staged Diafiltration for Monoclonal Antibody Formulation.” Zydney is an expert in bioseperations and the purification of high value biological products. Zydney received his Ph.D. in Chemical Engineering from M.I.T. in 1985 and previously worked on the faculty of the University of Delaware.
Associate professor Peng’s proposal is titled, “Diafiltration of Monoclonal Antibody using pH Responsive Membrane with Positive Charge.” Peng, a membrane technology expert, is the first ACS GCI PR grant recipient from an Asian country. Peng received her Ph.D. in Membrane Technology for Environmental Pollution Control at the Universti Sains Malaysia in 2008.
The ACS GCI PR has issued over $1.8 million dollars of grants to fund green chemistry research of relevance to the pharmaceutical industry. The ACS GCI PR website shows a complete list grants issued and resulting papers published.
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