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Introduction of a process mass intensity metric for biologics

Publication Date
Authors
Author Name
Kristi Budzinski
Author Name
Megan Blewis
Author Name
Philip Dahlin
Author Name
Daniel D'Aquila
Author Name
Julia Esparza
Author Name
Jack Gavin
Author Name
Sa V. Ho
Author Name
Clarice Hutchens
Author Name
David Kahn
Author Name
Stefan G. Koenig
Author Name
Robert Kottmeier
Author Name
Jeff Millard
Author Name
Matt Snyder
Author Name
Brad Stanard
Author Name
Lixin Sun

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.

Source
New Biotechnology
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