The biopharmaceutical and cell therapy industry requires cost-effective, scalable production of cytokines and growth factors, which are currently the most expensive components of synthetic media, costing $1,000–$30,000 per milligram and limiting the affordability and accessibility of advanced therapies.
Focusing on IL-2 and FGF2 cytokines, Potomac Affinity Proteins teamed with the University of Maryland to scale cytokine production reliably and at a fraction of the cost. The team aimed to use Potomac Affinity Proteins’ e. Coli expression system to create a platform process for cytokine production and purification that integrates molecular machinery into traditional manufacturing technologies. The process would allow for greater scale up potential at a reduced cost, while expanding flexibility for the industry to adopt the novel purification process for other critical cytokines or proteins.
Develop a novel low-cost purification technology to purify difficult to express tag-free proteins
While initial projections were ≥50mg per run, the team was able to produce and validate 1 gram of IL-2 and FGF2 cytokines respectively from 5 Liters of cell culture.
In addition to the nearly 2,000% increase over expected production, the team achieved a significant cost reduction of 90% - 99.8%, from $1k - $50k per mg to less than $100 per mg.
Reduce the cost of growth factors (by 10 fold) for cell therapy manufacturing
This basic methodology can be applied across additional cytokines beyond IL-2 and FGF2, but it also can be scaled-up to manufacture significantly higher quantities, reducing cost to only dollars per mg, potentially resulting in significant manufacturing cost savings.
The E. coli–based expression system with affinity-tag purification for IL-2 and FGF2 demonstrated in this project, will reduce growth factor production costs by more than 90% (from $1,000–$30,000/mg to under $100/mg), enabling scalable, one-day purification of gram quantities of cytokines and lowering the cost of cell therapy media.
Purification media was produced economically in a simple process.
Purification media was used to purify > 1 g of cytokine (IL2 or FGF2) from a 5L fermentation in a simple, one day process.
Purified IL2 and FGF2 passed all biophysical and biological validations using commercially available proteins as controls.
Bryan, P., Chen, Y., & Ruan, B., Enzymatic Purification Machines, NIIMBL National Meeting, Washington, DC, June 27, 2019.
Bryan, P., Chen, Y., Ruan, B., & Toth, E. A., Low-cost Production and Purification of Cytokines and Growth Factors for Cell Therapy Products, NIIMBL Member Forum, Virtual, July 25, 2019.
Bryan, P., Chen, Y., Ruan, B., Toth, E. A., & Simmerman, R., Fast, flexible, and economical system for affinity-tag protein purification and tag removal, NIIMBL National Meeting, Washington, DC, June 27, 2019.
Chen, Y., Bryan, P., Ruan, B., & Toth, E. A., Low-cost production and purification of cytokines and growth factors, NIIMBL National Meeting, Washington, DC, June 28, 2019.
Low-cost Production and Purification of Cytokines and Growth Factors for Cell Therapy Products (PC2.1-067), NIIMBL Member Forum, Virtual, February 26, 2021.
Low-cost Production and Purification of Cytokines and Growth Factors for Cell Therapy Products (PC2.1-067), NIIMBL Member Forum, Virtual, March 26, 2020.
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Potomac Affinity Proteins
University of Maryland College Park
