Biomanufacturers must take active measures to minimize their environmental footprints and promote environmental sustainability. The collateral benefit of reducing environmental footprint often is viewed as only a secondary consideration after cost of goods and product quality. Biopharmaceutical processes are 80% defined by the time of proof-of-concept studies (clinical trial stage 2b). This milestone is before the official technical transfer to commercialization or manufacturing organizations and almost always before the environmental evaluation of a production process. This step is considerably earlier in the development lifecycle than it is for the development of pharmaceutical products. Consequently, an urgent need exists to rebalance current process evaluation criteria and advance evaluation timing to raise emphasis on environmental footprint reductions early in biopharmaceutical product development.

Because the number of biopharmaceutical products is increasing and bioprocess productivity is rising, several biomanufacturers are redefining their missions or in some cases constructing new facilities. Therefore, the opportunity is expanding now to examine these environmental footprints. I’ve developed an initial framework for assessing microbial and animal cell biopharmaceutical processes, focusing on opportunities in early stage process development. Part 1 of this article identifies the impact of solid waste disposal. In an upcoming issue, Part 2 will discuss waste water, electricity, and air emissions.

PRODUCT FOCUS: ALL BIOLOGICS

PROCESS FOCUS: UPSTREAM AND DOWNSTREAM

WHO SHOULD READ: PROCESS DEVELOPMENT AND MANUFACTURING

KEYWORDS: SINGLE-USE, DISPOSABLES, SUSTAINABILITY, ENVIRONMENTAL IMPACT

LEVEL: INTERMEDIATE

About the Author

Author Details
Beth Junker is senior scientific director at Merck and company, RY808-130, PO Box 2000, Rahway, NJ 07065; [email protected].

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