MIT LGO students can apply their engineering knowledge to sustainability problems that impact a global operations system. Students work with renewable energy sources, measure company’s environmental impact, and make suggestions based on rigorous data analysis. Many of the sustainable engineering projects we currently have focus on energy and have a sustainability component, usually working with renewable energy sources.
Establishment of Novel Pichia pastoris Host Production Platforms
Ellen Coleman (LGO ’20)
Problem: The Cell Line Development group at Amgen is responsible for manufacturing and optimizing the cell lines utilized in production of Amgen’s biologic drug portfolio. Traditionally, these cell lines are produced from mammalian host organisms, primarily Chinese Hamster Ovary (CHO) cells. Advancing alternative hosts offer a unique opportunity to manufacture biologics at fractions of current speed and costs.
Approach: Advancing Pichia (alternative yeast host) strain engineering technology will eventually drive broader utilization in commercialized products and help curb the rising cost of biologic medicines. Ellen’s project objective was to perform Pichia cultivations to provide proof-of-concept process data. She aimed to quantify the strategic advantage of the Pichia host in Amgen’s pipeline, and determine when, why and how such a product would be manufactured.
Impact: Overall, Pichia offers an entirely new operational challenge for the scientists’, engineers and strategists at Amgen to consider. A few of the key outcomes from Ellen’s project include:
- Alternative host materials produce similar productivity as published results
- Pichia has potential to reduce raw material cost per lot by ~ 40%
- Operational cost savings must be evaluated on a per facility basis
Enabling Dematerialization of Product Development, Transfer and Manufacturing
Janelle Heslop (LGO ’19)
Problem: Amgen competes globally to advance important medicines in a highly competitive marketplace facing increasing pressures from pricing and regulatory scrutiny. To prepare for this changing business environment, Amgen needs to develop a manufacturing strategy that can enable the production of high-quality products with significant reduction in timelines and cost. Biomanufacturing of tomorrow must enable speed to market, flexible manufacturing, reduced footprint and improved efficiency.
Approach: Janelle’s project followed a structured approach to develop knowledge and tools that can be used to improve decision-making around next generation manufacturing technologies for both Drug Substance and Drug Product in Process Development. Her project used four major work-streams:
- Technology landscaping for process, prioritizing process units for evaluation
- Development of criteria for technology evaluation
- Evaluation of selected tech based on criteria
- Development of playbooks to capture technology assessment and use cases
Impact: Janelle identified three critical evaluation areas for assessing next generation manufacturing technologies: economic, environmental, and operational attributes. She demonstrated that the evaluation framework helped in meeting a critical need for technology decision-makers at Amgen: the need for an objective and standard methodology for evaluating and deploying new technologies in the manufacturing network. Based on Janelle’s work, Amgen can further refine this framework to ensure that it reflects its most critical business priorities and that it can be used broadly across many process areas.